Sr. Validation Engineer

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 the U.S. MTO MS&T Team, you will be responsible for implementing process validation, primary packaging validation, cleaning validation and revalidation activities to meet cGMP requirements on time, on budget and quality to ensure that programs are compliant with inspection agencies' requirements and Alcon Quality Modules at our ASPEX Manufacturing Facility in Fort Worth, TX.

In this role, a typical day will include:

• Ensures that assigned validation activities are performed timely and in line with the current Alcon requirements and cGMP, handling any deviations associated with these activities.
• Authors validation protocols and technical reports (e.g., Pre-Validation Studies, Performance Qualifications, Requalifications, Annual Monitoring Batches).
• Performs process qualification for new equipment and new technologies.
• Participates in transfers and launches.
• Contributes to providing experimental data obtained during the validation activities, which will be used to prepare the related registration documentation.
• Performs risk assessments for Validation.
• Participates in improvement and remediation of products.
• Provides Validation oversight review and approval of Production documentation, e.g., Master Batch Records (MBRs) and Standard Operating Procedures (SOPs).
• Maintains assigned documentation and work area in inspection readiness level and provide necessary support in any internal or external audit.
• Owns the Training Curriculum for assigned Job Profile and provide training and support to new associates joining related functions.

WHAT YOU'LL BRING TO ALCON:

• Bachelor’s Degree or Equivalent years of directly related experience (or high school +8 yrs.; Assoc.+4 yrs.)
• The ability to fluently read, write, understand, and communicate in English.
• 2 Years of Relevant Experience.
• Work hours: Monday-Friday; 8:00am-5:00pm; occasional weekends
• Travel Requirements: None
• Relocation assistance: No
• Sponsorship available: No

PREFERRED QUALIFICATIONS:

• Experience in manufacturing/manufacturing science and technology/technical development/Quality.
• Thorough understanding of manufacturing processes and related process equipment.
• Working knowledge of applied statistics, quality systems and regulatory requirements across multiple health authorities.
• Experience in executing process validation.
• Advanced in writing and reviewing protocols and technical reports.
• Fundamental understanding of standard pharmaceutical analytical testing.
• Recognized Subject Matter Expert (SME) in at least two validation topics.

HOW YOU CAN THRIVE AT ALCON:

• Collaborate with teammates to share standard processes and findings as work evolves.
• 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, and much more!

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.