Sr. Staff Program Manager, Commissioning & Qualification

• Steriles

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

About Thermo Fisher Scientific

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 $143,000.00–$180,000.00. This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy.

We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs
• Employee assistance and family support programs, including commuter benefits and tuition reimbursement
• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
• Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards

Equal Opportunity

Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.