Job Summary

Responsibilities

·       Performs visual inspection of lot numbers, expiration dates, inserts, trays, partitions, over packs, packing and palletizing over packs

·       Will work on assembly lines with high speed computer-based equipment with HMI applications

·       Assures that the packaged product meets all [100%] of specifications

·       Responsible for complying with all SOP’s and cGMP’s.

·       Responsible for complying with training.

·       Maintains a clean and organized work environment and strives to meet daily goals

·       Makes minor adjustments and assists with changeover and set-up to equipment, as necessary

·       Performs and documents line clearances before and after the running of each batch.

·       Assures a safe working environment and wears appropriate safety equipment/apparel at all times as well as alerting the supervisor to unsafe conditions in the department

·       Performs other duties as assigned

·       Works overtime as needed

REQUIREMENTS

·       High school diploma or equivalency required

·       One – Three years of manufacturing/packaging experience

·       Basic problem solving, mechanical skills required

·       Good communication skills are necessary

·       Attention to detail is essential

·       Ability to lift up to 40 lbs to waist high regularly is required

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

Job Summary

Responsibilities

PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT

·       Supervises daily activities of scientists and technicians.  Assures that job activity deadlines are met on a timely basis.

·       Hires and oversees the training of department personnel.  Assures that steps are taken to maintain positive personnel morale and development.

·       Conducts performance evaluations.

·       Assures execution of monitoring and testing programs to assess the quality of raw materials, components, in-process and finished goods, environmental systems/utilities systems and effectiveness of production processes.

·       Establishes goals for the timely release of product and performance of projects.  Monitors performance of the group against the goals to identify and implement needed corrective action.

·       Generates new/revise Standard Operating Procedures for Microbiology test procedures.

·       Ensures that raw material, component, product, or monitoring results that do not meet specifications or expectations are promptly investigated.  Identifies possible source and corrective action needed and evaluates the impact upon the product.

·       Identifies significant adverse quality trends by preparing and analyzing summary reports.  Addresses quality control test results, microbial profiles of environmental/utilities systems, and customer complaints.

·       Reviews work performed by department staff for accuracy, completeness and conformance to specifications.

·       Oversees training of departmental personnel in appropriate technique and related topics.

·       Mentors and develops new department personnel including training in Standard Operating Procedures and training checklists.

·       Assures department is equipped with functional, calibrated equipment and necessary supplies.

·       Supervises investigations of non-conforming raw material, product or components and determines disposition.

·       Works closely with Production, Quality Assurance, Chemistry, Maintenance, Metrology and Validation departments to ensure area environmental monitoring, product testing, PM, calibration and re-qualification schedules are met.

·       Supervises qualification/requalification program for production and laboratory personnel.

·       Investigates and resolves non-conforming test results by completing thorough Deviation, OOS/OOT, EE and Investigation.

·       Ensures adequate evaluation of new product processes. 

·       Supervises validation activities for responsible area.

·       May act as a Manager in the absence of the manager.

·       Represents the department in cross functional teams and meetings.

·       Assumes other duties and responsibilities as assigned

REQUIREMENTS

·        B.S. in Microbiology or related Science with five (5) to ten (10) years of progressive pharmaceutical lab experience. 

·        Associates degree in related field with 12-15 years of progressive experience including 1-2 years of supervisory experience.

·        Equivalent combined of education and experience in pharmaceutical manufacturing, related industrial or clinical experience accepted.

·        Excellent verbal and written communication skills are essential.

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

Job Summary

Responsibilities

PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT

• Responsibilities include active partnership with others to select and manage vendors, design, select, and modify equipment and processes.
•     Repairs and maintains machinery and equipment used in the manufacturing of process utilities according to standards.
•     Checks and inspects equipment periodically to determine the need to repair or conduct preventative maintenance.
•    Carries out preventive maintenance on equipment and or systems as required by Standard Operating Procedures (SOP’s).
• Implement peripheral equipment used in the facilities and utilities process.  Supports the integration of purchased equipment during acceptance, installation, and validation. Responsible to lead other technicians to plan equipment maintenance, PMs, and performance improvements.
• Key contributor to support/ author workplace documentation.
• Identifies and implements significant continuous improvement projects on existing processes. 
• Provides leadership to enable improved manufacturing technology and process outcomes.

• Provides coverage for other mechanics and helpers as within one’s abilities, such as daily readings, changing expendable items and other tasks as requested by the maintenance supervisor.
• Uses critical thinking skills to determine possible causes of equipment failures.
• Assumes other duties and responsibilities as required.

REQUIREMENTS

• Position requires 5 or more years or relevant experience serving in a mechanic role.
• Must be an expert in the maintenance and troubleshooting of facility/utilities equipment, including a working knowledge of automated control systems boilers, HVAC system, refrigeration, compressed gases, steam and WFI generation.
• Must possess excellent documentation, communication and planning skills.
• Must be able to teach and train others.
• Must be able to work overtime as necessary.

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

Job Summary

Responsibilities

PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT

·       Be able to articulate work related issues clearly and effectively to management and peers

·       Completes testing and documents in compliance with Good Documentation Practices.

·       Maintains accurate records of all work performed

·       Completes assessment of testing results and recognizes results not meeting acceptance criteria. Promptly reports data discrepancies and out of limits conditions to supervision.

·       Carries out documentation, investigation, author incident reports, and conducts corrective actions as assigned.

·       Manages work and time based on departmental properties using own judgement and objective reasoning.

·       Performs good housekeeping practices

·       Follows safety related policies.  Makes recommendations.

·       Performs peer review of data to ensure compliance and accuracy

·       Maintains current training compliance through KabiLift

·       Assumes additional responsibilities as assigned

REQUIREMENTS

·       Bachelor of Science degree in biological sciences, or microbiology or Associates degree with 0 – 2 years of laboratory experience. 

·       Proficiency in Microsoft Office

·       Excellent verbal and written communication skills are essential.

·       Planning and organizational skills necessary for primary responsibilities.

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

Job Summary

Responsibilities

PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT.

·       Responsibilities include active partnership with others to select and manage vendors, design, select, and modify equipment and processes.

·       Implement peripheral equipment used in the manufacturing/packaging/material conveyance process.  Supports the integration of purchased equipment during acceptance, installation, and validation. Responsible to lead other technicians to plan manufacturing equipment maintenance, PMs, and performance improvements.

·       Key contributor to support/ author workplace documentation.

·       Prepares and analyzes process and equipment layouts, helps optimize staffing efficiency, material flows, and quality improvements.

·       Identifies and implements significant continuous improvement projects on existing processes.  Performs individual engineering activities as directed.

·       Provides leadership to enable improved manufacturing technology and process outcomes.

REQUIREMENTS

·       Position requires 5 or more years or relevant experience serving in a technician role.

·       Must be an expert in the maintenance and troubleshooting of production equipment, including a working knowledge of automated control systems and design of machine tooling and equipment layout.

·       Must possess excellent documentation, communication and planning skills.

·       Must be able to teach and train others.

·       Must be able to work overtime as necessary.

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

Job Summary

Responsibilities

·       Performs visual inspection of lot numbers, expiration dates, inserts, trays, partitions, over packs, packing and palletizing over packs

·       Will work on assembly lines with high speed computer-based equipment with HMI applications

·       Assures that the packaged product meets all [100%] of specifications

·       Responsible for complying with all SOP’s and cGMP’s.

·       Responsible for complying with training.

·       Maintains a clean and organized work environment and strives to meet daily goals

·       Makes minor adjustments and assists with changeover and set-up to equipment, as necessary

·       Performs and documents line clearances before and after the running of each batch.

·       Assures a safe working environment and wears appropriate safety equipment/apparel at all times as well as alerting the supervisor to unsafe conditions in the department

·       Performs other duties as assigned

·       Works overtime as needed

REQUIREMENTS

·       High school diploma or equivalency required

·       One – Three years of manufacturing/packaging experience

·       Basic problem solving, mechanical skills required

·       Good communication skills are necessary

·       Attention to detail is essential

·       Ability to lift up to 40 lbs to waist high regularly is required

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

Job Summary

Responsibilities

• Manage and supervise the installation of equipment and/or facility modifications or additions to include selecting and coordinating suppliers, procuring equipment and services, scheduling, rigging, set-up, start-up, troubleshooting, de-bugging, training and budgeting.
• Develop and manage site projects by employing experience, research, design and concept sketches, layouts, drawings, supplier interaction, preparation of specifications, and discussions with appropriate management and site personnel.
• Understand the overall process sequences beyond individual equipment and impact on product quality.
• Analyze production and processing issues and initiate activities to resolve them.
• Develop product and process knowledge in process areas.
• Prepare and maintain process technical investigative reports for knowledge management.
• Identify, promote, and support the operation team on tasks/projects to improve product quality and yield.
• Design evaluation studies/ analysis of manufacturing equipment and systems, collect data, interpretation and report writing with supervisor guidance.
• Identify variances to assist in developing strategies to improve process performance and reduce cost.
• Promote strategies for efficiency improvements to operations.
• Support implementation of organization process improvement initiatives and evaluate results.
• Investigate deviations from standards of manufacturing process using effective root cause analysis tools.  Recommend effective corrective and preventative actions to operations team and support the implementation if required.
• Understanding of Critical Process Parameters (CPPs) and other process conditions needed to reliably manufacture product which consistently meets its Critical Quality Attributes (CQAs).
• Participate in risk assessments and validation activities.
• Maintains the interfaces with support functions (i.e., QA, QC, Engineering Services) and the production function to ensure availability of equipment and continuous improvement of the process.
• Assist with fundamental operation/equipment functionality training as appropriate.
• Set up and maintain process instruction for training and troubleshooting purposes.
• All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities

Requirements:

• Must have a bachelor’s degree in Engineering.
• Must have at least 3-years manufacturing experience in a cGMP environment.
• Must have at least 3-years hands on experience with validated manufacturing process systems.
• Desirable to have Project Management experience in a food, pharmaceutical or regulated environment.
• Must be able to generate reports, deviations, or other technical documents.
• Must be PC literate with standard office applications (Word, Excel, PowerPoint, Project, Access) competency.
• Must have Knowledge and understanding of cGMPs, industry guidance, and aseptic techniques.
• Must have understanding of statistical analysis tools and methods.
• Desirable to have knowledge of cGMP Process and Product Validation requirements and techniques.
• Desirable to have knowledge and experience in cGMP CA/PA, root-cause analysis, risk assessment and investigation tools and techniques.
• Experience in Automated Batch, Continuous Process and Formulation systems is preferred.
• Experience in pharmaceutical instrumentation is preferred.
• Desirable to have experience with critical utilities (WFI, OFCA, Clean Steam, HVAC).
• Desirable to have CIP/SIP experience.
• Desirable to have Clean Room experience.
• Desirable to have Process Control and instrumentation experience.
• Desirable to have experience in Decontamination process in aseptic manufacturing.
• Knowledge of Clean Room Classifications is a plus.

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

Job Summary

Responsibilities

• Support project execution by partnering with project managers to lead project activities and deliverables.
• Learn and assist with coordination, improvement, and training on project management tools, templates, and processes.
• Participation in site Gemba walks and cross-functional meetings as a core team member and contributor, proposing and implementing small-scale solutions/improvements.

Requirements:

• Intern candidates must be permanently authorized to work in the U.S.
• Our internships are unable to accommodate OPT. 
• Interns are responsible for their own housing.
• Working toward a Bachelor's degree in a scientific or engineering program
• Currently enrolled as a student at an accredited college or university program
• Must be planning to return to school at the end of the summer break
• Must be solution-oriented, organized, and eager to learn. Experience with digital tools and systems is a plus.

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

Job Summary

Responsibilities

• Work on projects that improve key sustainability metrics at the site (water use reduction, energy reduction, waste reduction).
• Learn about ISO systems (14001, 45001, & 50001) and help us organize and manage our integrated system.
• Find, report, investigate, and lead corrective & preventative actions on environmental incidents such as leaking pipes, at risk stormwater drains, etc.  
• Attend meetings, be vocal and active, & help our employees see the benefits of sustainable practices.

Requirements

• Intern candidates must be permanently authorized to work in the U.S.
• Our internships are unable to accommodate OPT. 
• Interns are responsible for their own housing.
• Working toward a Bachelor's degree in Sustainability, electrical, chemical science or engineering programs
• Currently enrolled as a student at an accredited college or university program
• Be classified as a minimum of a sophomore
• Must be planning to return to school at the end of his/her break

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

Job Summary

Responsibilities

PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT

·        Responsible for describing problems, identifying possible causes, collecting and organizing existing data, comparing causes to facts, identifying probable root causes, and determining the best solutions in order to control the manufacturing process.

·        Responsible for managing multiple deviation investigations simultaneously.

·        Provides follow up and scheduling to ensure batch release process is not impacted by outstanding deviations.

·        Ensures investigations will withstand regulatory scrutiny and are compliant with cGMP regulations.

·        Works with process experts and production personnel to fully understand and solve problems,

·        provides technical expertise and recommends improvements.

·        Writes Impact Assessments and Investigation Reports, works within TrackWise.

·        Assigns corrective/preventive actions (CAPAs) as necessary in order to resolve problems.

·        Performs continuous review and follow-up on investigations to minimize overall product impact and ensure the timely disposition of product that is directly affected.

·        Informs Management on the progress of on-going investigations, provides information to and takes direction from the Deviation Review Board.

·        Utilizes Word, Excel, Documentum and other electronic systems to complete tasks.

·        Maintains compliance with company policies, training requirements, cGMPs and safety standards.

REQUIREMENTS

·        BS/BA degree (experience may be considered in lieu of degree).

·        Must have at least three years of experience in a GMP manufacturing environment, writing standard operating procedures and protocols and/or reports

·        Requires advanced critical thinking skills

·        Must be familiar with regulatory (FDA) requirements

·        Good organizational, communication, and interpersonal skills are necessary

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

Job Summary

Responsibilities

PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT

• Supports the project team with respect to scaling up processes, new equipment and procedures, equipment and process validation, and manufacturing of development, stability, and process qualification batches.  Assigned projects will have a limited scope. Assists in preparing the manufacturing site for the manufacture of new products.  Communicates as necessary with the various plant departments, other support departments, project team members, and other internal customers.
• Prepares master batch records and protocols for the manufacture of development, stability, and process performance qualification batches.  Works with management to translate development findings into manufacturing processes. Technically assesses manufacturing processes by risk analysis method(s) and uses results to design robust manufacturing processes.
• Provides information and documentation needed for regulatory submissions or responses as required. Provides technical assessment of changes in manufacturing through appropriate review of documentation and testing results. Executes necessary investigative studies to address product deviations and changes to a manufacturing process. Supports product life cycle through execution of continued process verification reports.
• Supports cleaning validation/verification program by calculating limits, acting as study director for protocols, swab sampling, and evaluating products for cross contamination. Assesses feasibility of simple research and design concepts related to modernizing a product/product family or enhancing knowledge of a product/product family which includes but not limited to compatibility studies for tubing, vials, and stoppers, thermal cycling studies, light studies, and studies which support product insert.
• Consult with senior peers on non-complex projects to learn through experience. Technical reviewer for tables and basic protocols and final reports. Updates Standard Operating Procedures based on supporting validation. Perform any other tasks/duties as assigned by management.

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

Job Summary

Responsibilities

PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT

·        Responsible for describing problems, identifying possible causes, collecting and organizing existing data, comparing causes to facts, identifying probable root causes, and determining the best solutions in order to control the manufacturing process.

·        Responsible for managing multiple deviation investigations simultaneously.

·        Provides follow up and scheduling to ensure batch release process is not impacted by outstanding deviations.

·        Ensures investigations will withstand regulatory scrutiny and are compliant with cGMP regulations.

·        Works with process experts and production personnel to fully understand and solve problems,

·        provides technical expertise and recommends improvements.

·        Writes Impact Assessments and Investigation Reports, works within TrackWise.

·        Assigns corrective/preventive actions (CAPAs) as necessary in order to resolve problems.

·        Performs continuous review and follow-up on investigations to minimize overall product impact and ensure the timely disposition of product that is directly affected.

·        Informs Management on the progress of on-going investigations, provides information to and takes direction from the Deviation Review Board.

·        Utilizes Word, Excel, Documentum and other electronic systems to complete tasks.

·        Maintains compliance with company policies, training requirements, cGMPs and safety standards.

REQUIREMENTS

·        BS/BA degree (experience may be considered in lieu of degree).

·        Must have at least three years of experience in a GMP manufacturing environment, writing standard operating procedures and protocols and/or reports

·        Requires advanced critical thinking skills

·        Must be familiar with regulatory (FDA) requirements

·        Good organizational, communication, and interpersonal skills are necessary

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

Job Summary

Responsibilities

• Cleaning, changeover, setup, startup, operation, and breakdown of production lines.
• Use of proper aseptic technique at all times while working in aseptic areas.
• Documenting work accurately and in a timely manner
• Minor maintenance and preventative maintenance of production lines.
• Routine cleaning of production lines and other clean rooms.
• Unloading sterilizers and ovens.
• Adheres to SOP’s, cGMP’s and Safety Requirements.
• Performs “shadow” training of new Aseptic Control Operators.
• Performs other duties as assigned by management.

REQUIREMENTS

• High school diploma or equivalency required.
• Mechanical aptitude required.
• Must be able to lift 50 pounds with assistance
• Must be able to wear personal protective equipment
• Must work overtime as necessary to support production (weekday and weekends).

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

Job Summary

Responsibilities

• Cleaning, changeover, setup, startup, operation, and breakdown of production lines.
• Use of proper aseptic technique at all times while working in aseptic areas.
• Documenting work accurately and in a timely manner
• Minor maintenance and preventative maintenance of production lines.
• Routine cleaning of production lines and other clean rooms.
• Unloading sterilizers and ovens.
• Adheres to SOP’s, cGMP’s and Safety Requirements.
• Performs “shadow” training of new Aseptic Control Operators.
• Performs other duties as assigned by management.

REQUIREMENTS

• High school diploma or equivalency required.
• Mechanical aptitude required.
• Must be able to lift 50 pounds with assistance
• Must be able to wear personal protective equipment
• Must work overtime as necessary to support production (weekday and weekends).

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

Job Summary

Responsibilities

• Cleaning, changeover, setup, startup, operation, and breakdown of production lines.
• Use of proper aseptic technique at all times while working in aseptic areas.
• Documenting work accurately and in a timely manner
• Minor maintenance and preventative maintenance of production lines.
• Routine cleaning of production lines and other clean rooms.
• Unloading sterilizers and ovens.
• Adheres to SOP’s, cGMP’s and Safety Requirements.
• Performs “shadow” training of new Aseptic Control Operators.
• Performs other duties as assigned by management.

REQUIREMENTS

• High school diploma or equivalency required.
• Mechanical aptitude required.
• Must be able to lift 50 pounds with assistance
• Must be able to wear personal protective equipment
• Must work overtime as necessary to support production (weekday and weekends).

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.