Sr. Manager, Commissioning, Qualification, and Validation

Thermo Fisher
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Job Details

  • Location: Austin, TX, 78716
  • Date Posted: 5 months ago
  • Employment Type: Full Time
  • Category: Engineering
  • Req Number: 190256BR-1
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Description

Job Title: Sr. Manager, CQV
Requisition ID
:190256BR


When you’re part of the team at Thermo Fisher Scientific, you’ll do important work. And you’ll have the opportunity for continual growth and learning in a culture that empowers your development. With revenues of more than $35 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.


Position Summary:

The Sr. Manager of CQV/ Validation will help build a divisional team to lead a professional support staff and contractors responsible for commissioning, qualification, and validation of GMP facilities, equipment and critical building and utility systems within Bioscience Division. This includes the design, implementation, and documentation of these validations and their lifecycle management in compliance with FDA and EU regulations.

Key Responsibilities:

  • Establish and improve mechanisms to ensure the CQV team provides the required support in a timely, efficient and quality manner.
  • Develop a team accountable for all aspects of validation and re-validation activities to maintain performance as required by schedule and/or project timelines.
  • Define and implement divisional standards that will be used across the newly forming CQV team.
  • Oversee generation, review, approval and control departmental documentation (e.g., SOPs, protocols, final reports, data trends). Mentor in document revisions, providing input, as necessary.
  • Drive accountability towards operational excellence within CQV workstream.
  • Oversee the generation and execution of Validation life cycle documentation such as Systems Commissioning, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Design Qualification (DQ) Validation Summary Reports, and Deviations reports for Manufacturing and process Equipment & Utilities as per Thermo Fisher guidelines.
  • Support Computer System Validation activities!
  • Actively engage as a member of the divisional Engineering Leadership Team, collaborating with Capital Projects, Facilities, Utilities, and Maintenance Engineering counterparts to drive department strategy, innovation, and action.
  • Establish and maintain cross-site relationship with other Thermo Fisher sites to promote and maintain standard methodologies.
  • CQV team will represent the company at regulatory inspections (internal, external including FDA & MHRA), respond to questions, co-ordinate responses and corrective actions as appropriate validation impact assessments.

How to get here?

  • Bachelor’s Degree in Engineering, Science or related technical field highly preferred or an equivalent combination of education and experience.
  • Proficient with computers (MS Office). Solid understanding of controlled documentation and data systems.
  • In depth knowledge of cGMP regulations.
  • 10+ years within a GMP Environment
  • 8 + years of experience within Validation
  • 5 + years of supervisory experience is preferred.
  • Extensive knowledge of validation activities including plan and protocol generation, execution, final report approval/closeout, change control and performing validation impact assessments.
  • Experience with performing qualifications in the Biotech industry.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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