Total 3 job vacancies by 1061 Amgen Technology (Ireland) UC

Career Category

Job Description

The Manufacturing Process Technician at Amgen plays a crucial role in the operation and maintenance of manufacturing equipment. This individual is responsible for monitoring and adjusting manufacturing processes, troubleshooting any issues, and ensuring the quality of final products. They work in compliance with company policies and safety regulations.

Career Category

Job Description

Job Description Summary

The Manufacturing Process Technician reports to the Shift Manager and will be responsible for one or more of a number of roles relating to the manufacture of sterile parenteral drugs to include but not limited to operation and set up of manufacturing equipment, processing of parts and components for manufacturing, performing transactions in electronic systems such as EBR, LIMS, SAP etc. and cleaning and sanitization of production areas.

This job specification outlines the general responsibilities associated with the role of Manufacturing Process Technician on the Amgen Manufacturing Site. The site is focused on continuous improvement of all work processes and practices and all colleagues are required to be flexible in this regard. This means that they may be asked to carry out additional work functions that are not described in this specification but are associated with their role.

Please note this is a Fixed Term Contract role for 24 months and successful candidates will be required to work a shift pattern.  Candidates must have previous aseptic experience.

Hiring Requirements:

• Manufacturing Process, Packing and Inspection Technicians are required to work a variety of shift patterns including days, 2, 3 and 4 cycle shifts.

• They will perform all operations with due care and attention and in accordance with Good Manufacturing Practices and Amgen requirements.

• They will be involved in problem solving and troubleshooting including initiation and documentation of investigations.

• They will be responsible for the performance of self-inspection Quality & Safety Audits within their functional area.

• They will be part of a learning and development program which will include annual reviews and goal setting via the Maximizing Amgen Performance (MAP) process. They will be responsible for the cross training of other colleagues.

• They will be responsible for the use, review, revision and upgrade of operational documentation and peer review of operations.

• They will play a key role in the development of the manufacturing systems and will be responsible for continuous improvement initiatives. Proactively identifying operational improvement opportunities or process related issues including escalation & follow up with area Sr. Associate Tech Engineers for effective resolution and implementation.

• They will be champions for safe working practices and safety initiatives within their functional area.

• They will carry out any sampling, testing and inspections that may be required.  They will also carry out calibration and maintenance of test equipment.

• Contribute and assist with Corporate, FDA, IMB Auditors and other regulatory bodies during company audits.

• They will carry out any other duty as may be designated by supervisor/ management from time to time.

Qualifications:

• Educated to Leaving Certificate standard or equivalent (minimum five passes including English and Mathematics required).

• A third level qualification in a relevant discipline would be an advantage.

• Applicants should have some relevant experience of operation of a manufacturing function in a sterile pharmaceutical manufacturing or similar environment.

• Be a results-oriented person with excellent organization, communication and team development skills with an ability to successfully interact with people, create a team environment and generate co-operation.

• Demonstrated ability to deliver to team, site and personal objectives.

• Demonstrated understanding and use of RFT techniques and lean manufacturing concepts.

Preferred Skills:

Experience working with equipment utilised in the manufacture of parenteral products such as autoclaves, filling lines, formulation vessels plus:

•Good mechanical aptitude

•Excellent problem-solving skills

•Ability to work in a team environment and on one’s own initiative

•Experience working in Grade A/B area.

Career Category

Job Description

Primary Responsibilities:

The Senior Maintenance Technician will report to a Maintenance Manager and will work within the Filling, Lyophilisation or Inspection & Packaging maintenance teams with the primary responsibilities laid out below.  As the site expands, development opportunities may exist to transfer between teams and to gain experience with the equipment in each area of the plant mentioned above.

Equipment Maintenance

• Execute advanced maintenance activities on process equipment in accordance with standard operating procedures across multiple production and packaging facilities.
• Perform troubleshooting and equipment investigation works while assuring minimal impact to plant operations and in compliance with good maintenance practices, SOP’s and GMP requirements.
• Ability to work independently and as part of a team, taking responsibility for completion and handover of work, GMP documentation and ongoing maintenance of training qualifications.
• Demonstrated ability to participate in cross-functional teams to investigate non-conformances, deviations, and troubleshoot issues to establish root causes and corrective actions.

Projects and Continuous Improvement

• Support projects and start-up of new process plant, inspection or packaging equipment.
• Support process investigations, trials, machine upgrades and testing in conjunction with the wider engineering team.
• Assist with the development, execution, and support of the CQV (Commissioning, Qualification, Validation) process.
• Identify and implement improvement ideas to enhance equipment operation, reliability and the efficiency of maintenance programs.

GMP and Compliance

• Maintain high levels of aseptic compliance and housekeeping standards in manufacturing areas, workshops and training areas whilst operating as part of a cross functional team to support the plant.
• Demonstrated ability to self-maintain online and practical training or qualification status in compliance with site operating procedures and key area metrics.
• Ensure work is undertaken in a safe, compliant manner in accordance with legislative, site and corporate safety and quality procedures.

Documentation

• Ensure that maintenance documentation is completed accurately and in accordance with applicable procedures such as ALCOA+ principles.
• Develop, revise & review relevant technical documents (Maintenance SOP’s, Job Plans, P&IDs etc.) in conjunction with the broader Engineering support team.
• Familiarity with the purpose and use of CMMS systems, Electronic Batch Records and electronic logs.

Primary Knowledge and Education:

• Recognised apprenticeship in an electrical / mechanical craft.
• Leaving Certificate or equivalent (minimum five passes including English and Mathematics).
• Ability to read and understand mechanical drawings, technical manuals, electrical wiring schematics, layout drawings and P&ID’s.

Preferred Qualifications and Experience:

• Combined education, training and experience in mechanical / electrical maintenance, experience in a regulated manufacturing environment would be an advantage.
• Any relevant experience in an automated inspection and packaging environment would also be an advantage.
• Knowledge and experience working in a pharmaceutical or aseptic manufacturing facility.
• Knowledge of pneumatic, mechanical, hydraulic systems and ability to effectively perform associated maintenance activities on these systems.
• Knowledge and experience of working with electrical panels.
• Experience executing and documenting maintenance work in a computerised maintenance management system.
• Ability to interpret P&ID's, identify hazards, isolation points and inter-dependancies between services for LOTO purposes.
• Ability to work with minimum direction, identify issues and effectively communicate the status of equipment or tasks in a timely manner.