Reference : 586580

Quality Validation Engineer - OPEX, Life Sciences

  • Technical Production
  • United States CLEARWATER
  • Permanent / Regular (US)
  • Posting date : 06/10/2021

Position description

Quality Validation Engineer - OPEX, Life Sciences

Location:   Clearwater FL

If you want to reshape the world and 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 Quality Validation Engineer demonstrates quality in all actions.  This position will report through the World Wide Corporate Quality Validation Manager, but will directly support all validation work functions of the OPEX (i.e. Operational Excellence) Corporate Group. This position provides support and oversight to the Operational Excellence Program/Group at Saint-Gobain Life Sciences.  The focus of Senior Engineers within this job description, will be the support of large capital projects, and Technology Transfer projects (products and or processes) which include Facilities Validation, Utilities Validations, Product/Process Validations, and Equipment Validations.  This candidate will provide critical aspects of the Validation work-function supporting the OPEX team in: requirements development, test protocol writing and approvals, all protocol executions, validation testing exceptions with root-cause investigations and resolution through corrective actions, and final validation report/ package compilation.  Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Demonstrates good judgment in selecting methods and techniques for obtaining solutions. Networks with senior internal and external personnel in own area of expertise.

 

Essential Functions

Facility and Utilities Validation Programs:

•           Oversees and executed facility and Utilities validation activities in Operations settings.

•           Continually analyzes environmental and/or utility monitoring data from the manufacturing areas for purposes of remediation of any developing trends.

•           Ensures adherence of manufacturing activities to program requirements and regulatory expectations.

•           Ensures quality of product through observation/auditing, investigations, training and management of procedures.

•           SA objectives are achieved through this position’s active involvement and leadership in SA / EM related deviations, procedure revisions, training programs, CAPA and Change control management systems, as well as through informal and formal auditing. In addition, this position helps ensure operations understanding of SA program through meetings and other means of communication.

Equipment and Process Validation:

 

  • Collects and can interpret critical process and equipment data in support of test protocol development

     

  • Understands and Develops process flow diagrams associated equipment operation and the manufacturing process

 

  • Develops Standard operating procedures in support of the release of the process or system to manufacturing

     

  • Writes critical validation test document IQ/OQ/PQ or Process Validations

     

  • Manages the validation document approval process

     

  • Executes the validation testing per the approved test protocols

 

  • 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

REQUIRED QUALIFICATIONS

  • Bachelor’s degree in Engineering, Biology, Microbiology, Chemistry, or a related degree with scientific, engineering, clinical or regulatory course of study optimal. Degree in Biology strongly preferred.
  • Technical certification/training in HVAC systems and sterilization sciences preferred.
  • 3-5 years’ experience in facility, utility, equipment IQ, OQ, PQ and PV required.
  • Regulatory environment experience of medical devices (validation and routine control of devices), CFR 820, 210/211 and/or ISO 13485 required.
  • Must be able to travel 75-80% to support all LS plants.  May need to support longer campaigns of 3 to 6 months in specified project locations

Who are we ?

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.

 

Invent yourself at Saint-Gobain Life Sciences; and together, we’ll create a better life.

Legal Statement

Saint-Gobain provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, 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.

Top Employer 2021