Senior Manager, Validation and Aseptic Processing

Thermo Fisher Scientific • Grand Island, NY

76d • $118,100 - $177,200

About The Position

At Thermo Fisher Scientific team, you'll discover impactful work, innovative thinking and a culture dedicated to working the right way, for the right reasons - with the customer always top of mind. The work we do matters, like helping customers find cures for cancer, protecting the environment, making sure our food is safe and delivering COVID-19 solutions. As the world leader in serving science, with the largest investment in R&D in the industry, our colleagues are empowered to realize their full potential as part of a fast-growing, global organization that values passion and unique contributions. Our commitment to our colleagues across the globe is to provide the resources and opportunities they need to make a difference in our world while building a rewarding career with us.

Requirements

• Bachelor's or Master's in a science/engineering field; advanced degree preferred.
• 5+ years in GMP environments with strong validation and aseptic manufacturing experience; multi-site experience preferred.
• Demonstrated expertise in validation lifecycle management, aseptic behavior programs, internal auditing, and CAPA leadership.
• Strong knowledge of applicable regulations and standards; excellent communication, influence, and ability to independently lead project teams.
• Good understanding of statistical techniques, with six sigma certification a plus.

Responsibilities

• Establish and maintain a standardized aseptic behavior framework, including procedures, training, observations, and metrics across all sites.
• Perform periodic risk assessments of aseptic operations; implement mitigation strategies, and verify effectiveness.
• Lead gemba/behavioral observation programs and raise systemic issues; manage and report key performance metrics to leadership.
• Explore and train on current industry knowledge and changing expectations to maintain status as a subject matter authority.
• Own QA oversight for process, cleaning, equipment, utilities, computerized systems, etc.
• Approve validation and qualification outputs; ensure documented rationale, statistical adequacy, and data integrity.
• Harmonize validation standards, templates, and practices; drive cross-site consistency and change control governance.
• Ensure alignment with corporate QMS, GMP, GxP, and relevant regulations/standards (e.g., ISO 13485, MDSAP, FDA/ICH).
• Partner with Operations, Engineering, MSAT, and QC on tech transfers, change controls, deviations, and investigations with validation impact.
• Review regulatory trends; update policies/SOPs and training to maintain compliance.
• Lead a matrixed cross-site team; provide mentoring, workload prioritization, and competency development in validation and aseptic practices.
• Present performance, risks, and improvement plans to senior leadership; secure resources and drive accountability.

Benefits

• Competitive remuneration
• Annual incentive plan bonus
• Healthcare
• 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
• Short- and long-term disability
• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Computer and Electronic Product Manufacturing
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees