Sr. Program Manager, Commissioning and Qualification - Steriles; Hybrid

Position: Sr. Staff Program Manager, Commissioning and Qualification - Steriles (Hybrid)
Location: St Louis

This job is with Thermo Fisher Scientific, an inclusive employer and a member of my Gwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.

Work Schedule
Standard (Mon-Fri)  Environmental Conditions
Office

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner, and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe, or helping find cures for cancer.

POSITION SUMMARY
As a Sr. Staff Program Manager, Commissioning & Qualification - Steriles,  you will engage with and support the sites within the PSG network. We are seeking a professional with in-depth knowledge of the commissioning, qualification and validation lifecycle. As part of the PSG global engineering team, this hybrid role provides CQV oversight to PSG sites having significant effect on the organization, complex site(s) and projects.

The Sr. Staff Program Manager will have good knowledge of manufacturing processes and equipment, regulations, quality management principles, and Facilities, Utilities, and Equipment (FUE) Qualification requirements to be effective in the conduct of responsibilities. The incumbent will be viewed as a subject matter expert for commissioning and qualification programs, regulations, and requirements.

** This is a hybrid position and this person needs to be in close proximity to one of the following sites - Plainville, MA;
Greenville, NC, St. Louis, MO.

KEY RESPONSIBILITIES
Ensuring site adherence to global validation policies and procedures
High level support for Capital Project validation within the network
Provide support for regulatory/customer audits, documents and engagements as needed to foster successful business outcomes
Support sites as needed with pre-inspection readiness within CQV space
Commissioning, Qualification and Validation SME

QUALIFICATIONS AND REQUIREMENTS:

Education:

• Bachelor's Degree in Engineering or related field.
In some cases an equivalency, consisting of a combination of appropriate education, training, and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Experience:

• 10+ years of related experience in the Pharmaceutical or related industry including experience in validation, engineering, operations, program and project management

• Extensive knowledge of full validation lifecycle requirements for Steriles Manufacturing, Biologics, Clean Utilities and Support Services.

• Audit experience strongly preferred

Knowledge, Skills and Abilities:

• Advanced knowledge of CQV for pharmaceutical equipment and systems (e.g Filling lines, Isolators, Autoclaves, Lyophilizers, Single Use Bioreactors and Mixers, WFI, Clean Steam, Process Gases, and ancillary equipment)

• Proven track record leading medium to large-scale capital projects through commissioning and qualification

• Advanced knowledge of applicable regulatory requirements (FDA, EMA, WHO, Annex 15, ISO, etc.) related to commissioning, qualification and validation

• Strong analytical and problem-solving capabilities

• Strong communication and presentation skills at all organizational levels

• Experience with risk management and mitigation strategies

• Ability to lead and influence in a matrix and global environment effectively

• Willingness to travel up to 20% as required, domestic/international

• Working knowledge of deviation and quality record platform (i.e. Track Wise)

• Experience qualifying systems using Kneat or other paperless validation tools is highly preferred.

• Ability to manage multiple high-priority initiatives simultaneously

• Experience working with global, geographically dispersed teams

Compensation and Benefits
The salary range estimated for this position based in Massachusetts is $–$.
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