Senior Validation Engineer

At Alcon were passionate about enhancing sight and helping people see brilliantly. With more than 25000 associates we innovate fearlessly champion progress and act swiftly to impact global eye health. We foster an inclusive culture recognizing your contributions and offering opportunities to grow your career like never before. Together we make a difference in the lives of our patients and customers. Are you ready to join us

This role is part of Alcons Engineering function a team focused on improving quality processes products packaging and materials across our business to help deliver brilliant outcomes.

The Sr. Associate Validation (Science/Tech/Engineering Path) is primarily responsible for supporting and completing validation and qualification activities for processes equipment systems and facilities. You will prepare review and rectify validation protocols provide technical support and help manage department expenses.

Specifics Include:

• Handle technical tasks supporting operations and contributing to efficiency within defined procedures.
• Plan execute and document validation studies to ensure equipment systems and processes operate effectively and comply with regulations.
• Conduct risk assessments design protocols analyze data and prepare validation and qualification reports.
• Support validation activities in aseptic process management.
• Review and approve change control documentation.
• Provide audit support and collaborate with cross-functional teams to drive problem-solving and innovation through scientific principles.
• Make decisions within the scope of assigned tasks requiring advanced technical knowledge and analytical skills.
• Perform assigned validation activities on time.
• Handle deviations associated with these activities if required.
• Author complex validation protocols and technical reports (e.g. launches transfers weak point remediation).
• Perform process qualification for new equipment and new technologies.
• Participate in transfers and launches by providing data obtained during related validation activities which are needed for the registration documentation.
• Perform or oversee risk assessments for Validation.
• Participate in improvement and remediation of products.
• Update documents on an as needed basis.
• Provide Validation oversight review and approval of change control documentation.
• Adhere to GxP regulations by strictly following Standard Operating Procedures (SOPs) maintaining accurate and complete documentation.
• Ensure rigorous quality control complete all required training and meet individual job requirements to contribute to overall organizational compliance.
• Commit to continuous improvement and compliance with regulatory requirements.

WHAT YOULL BRING TO ALCON:

• Bachelors Degree or Equivalent years of directly related experience (or high school 10 yrs; Assoc.6 yrs; M.S.0 yrs)
• The ability to fluently read write understand and communicate in English
• 2 Years of Relevant Experience
• Work hours: Exempt
• Travel Requirements: None
• Relocation assistance: No
• Sponsorship available: No

PREFERRED QUALIFICATIONS/SKILLS/EXPERIENCE:

• Experience working in a regulated pharmaceutical biologics medical device or aseptic manufacturing environment.
• Experience with change control deviation investigations CAPA and quality management systems.
• Proficiency in data analysis statistical methods and trending of validation data.
• Experience using statistical analysis software such as Minitab.
• Experience with temperature mapping thermocouple data loggers and thermal validation studies.
• Experience with sterilization validation including E-Beam EO steam or other sterilization technologies.
• Demonstrated project management organizational and cross-functional collaboration skills.
• Ability to independently manage multiple validation projects and meet established timelines.

HOW YOU CAN THRIVE AT ALCON:

• Join Alcons mission to provide outstanding innovative products and solutions to improve sight improve lives and grow your career!
• Collaborate with teammates to share standard processes and findings as work evolves!
• See your career like never before with focused growth and development opportunities!
• Alcon provides a robust benefits package including health life retirement flexible time off for exempt associates PTO for hourly associates and much more!

This position may be offered at the Associate I or Associate II Engineering level depending on the candidates qualifications and experience.

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ALCON IS AN EQUAL OPPORTUNITY EMPLOYER AND PARTICIPATES IN E-VERIFY

Alcon takes pride in maintaining an inclusive environment that values different perspectives and our policies are non-discriminatory in recruitment hiring training promotion or other employment practices for reasons of race color religion gender national origin age sexual orientation 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 and let us know the nature of your request and your contact information.