ASPEX Sr. Validation Manager

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 MANAGER , supporting our ENGINEERING CHEMICAL PROCESS TEAM, you will be trusted with  Developing, implementing, and managing site process validation, primary packaging validation, cleaning validation and revalidation strategies to meet cGMP requirements on time, on budget and quality to ensure that programs are compliant with inspection agencies’ requirements and Quality Modules at the ASPEX FORT WORTH MANUFACTURING FACILITY in FORT WORTH, TEXAS, US.  

In this role, a typical day will include:

• Establish and maintain the Validation Master Plan(s) (VMP) for process, product, aseptic manufacturing (media), cleaning, and packaging validation.

• Maintain overview of state of validation at site, ensure revalidation requirements are met, and establish the project prioritization across site.

• Partner with other functions (e.g., via division, regulatory inspection, changes in regulations) to establish and maintain common validation approach and translate that for the site.

• Partner with Engineering and QA to define the process validation/equipment/systems qualification interface. Support process qualification for new equipment and new technologies.

• Ensure that all site validation activities, including pre-validation and validation resulting from technical changes, are performed and are in line with the current Alcon requirements and cGMP.

• Establish and manage the respective validation plans by aligning, coordinating, and supervising the prioritization of activities against the business needs.  Reviews risk assessments for validation.

• Responsible to translate the critical process parameters and the process control strategy into a focused validation plan for process validation.

• Establish Risk Assessment program and provide guidance to site process owners for performing risk assessments.  Review risk assessments for Validation.

• Provide input to Quality Manual/Global Standard Operating Procedures to ensure the document is in line with global/local requirements and industry standards.

• Set local procedures and templates for respective validation documentation and validation master plan.

• Maintain assigned documentation and work area in inspection readiness level and provide necessary support in any internal or external audit.

• Ensure Validation oversight review and approval of Change Control documentation, Production documentation, e.g., Master Batch Records (MBRs) and Standard Operating Procedures (SOPs).

• Participate in transfers and launches for new products and align on the product validation approach. 

• Be a senior advisor in case of difficult validation challenges at site.

WHAT YOU'LL BRING TO ALCON:

• Bachelor’s Degree or Equivalent years of directly related experience (with high school diploma  +15 yrs; with Assoc. degree +11 yrs; M.S.+4yrs; PhD+3 yrs)

• The ability to fluently read, write, understand and communicate in English

• 7 Years of Relevant Experience

• 5 Years of Demonstrated Leadership

• Work hours: Monday through Friday – 8:00am – 5:00pm

• Travel Requirements: 0 to 10%

• Relocation assistance: No

• Sponsorship available: Yes

PREFERRED QUALIFICATIONS:

• Bachelor of Science in Chemistry, Pharmacy, Chemical Engineering, Pharmaceutical Technology, or equivalent/applicable scientific or engineering degree

• 8 years of experience in manufacturing/manufacturing science and technology/technical development/Quality, with 3 years direct supervisory or 5 years project management responsibility

HOW YOU CAN THRIVE AT ALCON:

• Collaborate with teammates to share standard processes and learnings as work evolve

• See your career like never before with 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!

ATTEN