Position Description

Job Summary

If you want to discover your greatest potential, Saint-Gobain provides one-of-a-kind opportunities for innovative problem solvers.

We're one of only two companies in the world that is consistently recognized as both a top Global Employer and a Top 100 Global Innovator, but Saint-Gobain's remarkable story and culture of innovation begins with a team of nearly 200,000 creative, diverse and passionate team members collaborating across the globe. We are committed to our mission to improve lives because, every day, we witness the enormous impact of our efforts on the world around us.

The Validation Engineer will provide support and guidance and execute the plan for validating equipment and processes to meet requirements for Life Sciences Systems. Will work on problems of diverse scope where analysis of data requires evaluation of identifiable factors.

While managing a team, will implement, maintain, and facilitate continuous quality improvement objectives, primarily cGMP and ISO 13485 for the plant.

Key Accountabilities:

Equipment and Process Validation: For both Portage and Poestenkill facilities.

• Writes and/or approves critical validation test document IQ/OQ/PQ or Process Validations as applicable.
• Manages the validation document approval process.
• Collects and interprets critical process and equipment data in support of test protocol development.
• Understands and develops process flow diagrams associated with equipment operation and manufacturing processes.
• Develops and maintains standard operating procedures in support of the validation and release of the process or system to manufacturing.
• Oversees and closely aligned with the execution of the validation testing per the approved test protocols.
• Ensures that the validation design outlined in the respective protocols is aligned with the respective risk assessment and statistical rationale for the process/ equipment under the scope of validation.
• Oversees measuring program generation, program modification, and associated validation activities required.
• Ensures compliance with software validation, process validations, equipment qualification, and test method validation procedures.
• Writes and manages approval of validation summary reports.
• Provides feedback to the plant leadership and project teams on best validation practices and approaches for project planning purposes.
• Oversees and executes facility and utilities validation activities in operational settings.
• Provides quality and validation-related training/education for company personnel

Quality Systems Support

• This position will perform special projects as assigned and review relevant regulatory guidance to identify gaps within site programs and develop remediation strategies with functional leads.
• Review change request documents as applicable.
• Ensures that project and process development documentation are compliant with requirements and objectives.
• Review design, change specifications, and plan against process requirements.
• Leads investigation as it relates to the assigned area of support.
• Ensures compliance with all customers', QSR, cGMP, ISO 13485, and Medical Device Directive requirements, as applicable.
• Reviews and approves updates needed to product specifications.

Metrology

• Manages the Metrology personnel and processes for both Portage and Poestenkill facilities.
• Understands Nikon programming.
• Understand various measurement systems and recommend the best solutions for projects.

Required Qualifications

REQUIRED QUALIFICATIONS:

Education:

Bachelor's Degree - Engineering, Biology, Microbiology, Chemistry or related degree with scientific, engineering or regulatory course of study; Required.

Master's Degree - Engineering, Biology, Microbiology, Chemistry or related degree with scientific, engineering or regulatory course of study; Preferred.

ISO 13485 - Internal Audit Training - Preferred.

Experience:

• 5+ years of Quality Experience within a highly-regulated manufacturing environment; Required.
• 5+ years of Engineering Experience; Preferred.
• 3+ years of Managing People Experience; Required.
• 3+ yeares of Management of customer interaction with appropriate written & verbal communication; Required.

• Strong Medical or Pharmaceutical quality experience with validation & Routine control devices; Required.
• Technical Writing Experience; Required.
• Travel ability upwards of 10%; Required.

Additional Description

Employees have the flexibility to choose the benefits that best fit their individual needs.

Health and Wellbeing - Supporting your wellbeing, to thrive in life and work.

• • Medical, Prescription Drug, Vision, and Dental Insurance
  • Healthcare Saving Account and Flexible Spending Account options
  • LiveWell Wellness Program
  • Employee Assistance Program (EAP)
  • Paid Time Off and Paid Parental Leave

Retirement and Protection - Helping to make the future life you want a reality.

• • • 401(k) with Company Match, Retirement Accumulation Plan (RAP), Cash Balance Pension Plan
    • Company-provided Life Insurance, AD&D, Short-Term Disability
    • Voluntary employee and dependent life insurance, Long-Term Disability, Critical Illness and Accident Insurance

Additional Benefits - Helping shape the experience and impact you want

• • Commuter Benefits
  • Group Legal
  • Identity Theft Protection
  • Auto and Home Insurance
  • Pet Insurance and Discounts
  • Back-up Child & Elder Care
  • PerkSpot Employee Discount Program

Company Summary

Saint-Gobain's innovations touch almost every major industry around the world. Within its Life Sciences division, teams are solving critical problems for customers who are getting life-saving medical devices to the frontlines of healthcare, discovering essential medications, and nourishing and connecting the world through consumer, industrial and electronics applications. As one of the world's leading producers of high-performance polymer products, we improve lives by making simple experiences better and being there in life's critical moments.

Our team members recognize that we all create the environment for people to succeed, with a culture built on respect, open and honest communication, and honoring our commitments to our customers and each other. And at the heart of our culture, we've learned working together makes good ideas, great ones.

With a legacy dating back more than 350 years, Saint-Gobain offers employees the stability and security of a leading Global 500 corporation while operating like multiple small and agile start-ups, where entrepreneurial spirit, pioneering teamwork, and bold, forward-thinking ideas pave new paths.

Every team member is encouraged to develop and leverage their unique expertise and strengths to make the greatest impact on the company and our end users. At Saint-Gobain, you're empowered and equipped with countless opportunities and resources for professional development. You will find the support you need to create a vision and roadmap for your career, and make that vision a reality.

Join Us at Saint-Gobain Life Sciences. Together, we'll create a better life.

Click here to Explore more opportunities within Saint-Gobain Life Sciences.

Legal Statement

Saint-Gobain provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. Saint-Gobain is an equal opportunity employer of individuals with disabilities and supports the hiring of veterans.