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U341 Alcon Research, LLC. Company

Senior Engineer I - Validations

Full-time

Sinking Spring - Columbia...

Engineering

8 months ago

At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the.....

At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers.

We foster an inclusive culture and are looking for diverse, talented people to join Alcon. As a Sr. Validation Engineer supporting Manufacturing Science & Technology, you will be trusted to work on design, develop, and implement new or revised production processes for the efficient/economical mass production of goods at Sinking Spring, PA.

In this role, a typical day will include:

Use principles based on validation and risk management tools (e.g. FMEA) to lead in the development and maintenance of Validation Master Plan(s)/Validation document(s)for process, systems, cleaning, and packaging.
Maintain the validation program for the manufacturing site in liaison with corporate/industry standards.
Establish and maintain an overview of the state of validation for assigned projects and product platforms and assist in establishing the project prioritization including leading resources for validation efforts.
Be responsible for the translation of critical quality attributes and critical process parameters into a focused risk-based approach for validation.
Collaborate with internal partners, including Quality Assurance, Engineering, Manufacturing, and Regulatory Affairs, to ensure alignment and consistency to validation procedures and timelines.
Support engineering activities, (e.g. support the Change Control creation) to ensure appropriate validation work is clearly defined resulting from technical changes.
Serve as the Lead validation representative for all internal, external, or regulatory inspections/audits to ensure site readiness in support of successful inspections e.g. no critical observations related to validation activities.
Lead commissioning, qualification, and validation activities related to medical device manufacturing and facility systems including custom automation equipment
Build validation protocols such as FAT/SAT/IQ/OQ/PQ ensuring compliance with regulatory compliance and industry standards as needed
Develop and implement measurement systems analysis protocol including Gage R&R (GR&R) and Attribute Agreement Analysis (AAA).
Analyze validation data, generate validation reports, and detail any deviations or non-conformances, implementing corrective and preventive actions as needed.
Stay up to date with current regulations, industry trends, and technological advancements in validation practices, ensuring compliance and suggesting process improvements when appropriate.
Mentor and guide junior validation engineers, promoting professional development and collaboration.

WHAT YOU'LL BRING TO ALCON:

Bachelor’s Degree or Equivalent years of directly related experience (or high school +10 yrs.; Assoc.+6yrs; M.S.+0 yrs.)
The ability to fluently read, write, understand and communicate in English
2 Years of Relevant Experience
1 Years of Demonstrated Leadership
Work hours: M-F
Travel Requirements: Minimal
Relocation assistance: None
Sponsorship available: None

PREFERRED QUALIFICATIONS/SKILLS/EXPERIENCE

Strong Equipment qualification and process validation experience, shown experience with custom automation is desired.

HOW YOU CAN THRIVE AT ALCON:

A career at Alcon offers focused growth and development opportunities!
Join Alcon’s mission to provide outstanding, innovative products and solutions to improve sight, improve lives, and grow your career!
Alcon provides robust benefits package including health, life, retirement, flexible time off for exempt associates, PTO for hourly associates, and much more!

ATTENTION: Current Alcon Employee/Contingent Worker

If you are currently an active employee/contingent worker at Alcon, please click the appropriate link below to apply on the Internal Career site.

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Alcon is an Equal Opportunity Employer and participates in E-Verify. Alcon takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to alcon.recruitment@alcon.com and let us know the nature of your request and your contact information.

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