Senior Manager, Validation and Aseptic Processing

Work Schedule

Environmental Conditions

Job Description

Senior Manager QA Validation Media Network

At Thermo Fisher Scientific team youll 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.

Role Intent

• Aseptic program leadership:Assess lead and continually improve the aseptic process/behavior program to ensure robust contamination control and GMP compliance.
• Validation governance:Lead the Quality review and approval of validation documents ensuring alignment to regulatory expectations. Conduct internal audits in the area of validation requirements seeking opportunities for systemic improvement.

Key Responsibilities

• Aseptic Excellence
  • 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.
• Validation Quality Oversight
  • 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.
• Quality Systems & Compliance
  • 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.
• Leadership & Partner Management
  • 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.

Qualifications

• Bachelors or Masters 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

Key Performance Indicators

• Aseptic behavior adherence and observation effectiveness across sites.
• Validation output quality (first-pass approval rate timeliness lifecycle review completion).
• Audit outcomes (findings severity CAPA closure on-time reoccurrence rate).
• Cross-site standardization adoption and sustained compliance metrics.

Benefits

We offer competitive remuneration annual incentive plan bonus healthcare and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative forward-thinking organization and outstanding career and development prospects. We offer an exciting company culture that stands for integrity intensity involvement and innovation!

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 100000 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.

Compensation and Benefits

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: Experience:

Senior Manager