Validation Manager

Manager, Validation Engineering

Thermo Fisher Scientific-Viral Vector Services (VVS) is a rapidly growing, dynamic gene therapy contract development and manufacturing organization (CDMO) that is seeking sharp individuals to bring the highest quality processes, products and testing to our clients. Placed in the forefront of our leading and groundbreaking Cell and Gene Therapy business enabling clients to cure genetic, rare, and otherwise untreatable diseases. Our employees are committed to making a difference in our organization, for our client partners and the patients we serve. We are looking for top talent with proven proficiencies and strong character to join our team and help lead our organization into the future.

The Validation Manager will own the overall strategy of the site Process engineering team, ensuring that the process engineering group maintains a key figure in driving tech transfers and site projects. The Manager will provide engineering leadership, mentorship, and will work closely with the Validation and Manufacturing teams.

Responsibilities

• Ensure all equipment and system design documentation is organized and meets cGMP regulatory standards.
• Establish and maintain key performance indicators in alignment with department and product supply goals, maintain and report applicable area or interpersonal metrics.
• Establish and detail the Plainville platform for client processes, enabling rapid tech transfers from clients to the site, while owning equipment readiness for all customer programs, including the generation of utilization heat maps and critical risk registers for all assets on site.
• Organize and lead ad hoc multi-functional teams to run investigations and implementation of changes.
• Drive continuous improvement and operational excellence through correcting processes and systems and instilling strong ownership and accountability.
• Ensure high levels of communication with team; Proactively identify and raise key risks and issues to system owners
• Drive technical leadership, program management and clients to implement product / process improvements; participates and / or may lead multi-functional projects.
• Acts as Engineering authority for assessments for change controls, validation protocols, and document changes.
• Generate, review and approve departmental documentation (e.g., SOPs, protocols, final reports, data trends).
• Plan, schedule, and resource with team members for validation project initiatives, including protocol generation, execution and closeout.
• Drive validation activities during the tech transfer of new products in the manufacturing facility, including the development of validation plans.
• Develop and maintain Requalification program for the site.
• Support client and regulatory audits.
• Establish and uphold cross-site relationships with other Thermo Fisher Scientific sites to develop and sustain collaboration and standard processes.

Qualifications

Bachelor's degree in Engineering or related field required. Master's degree or PhD desired.

B.S. with 8+ years' experience, or Master's degree with 6+ years' experience.

Preferred experience working in 2 or more functional areas.

Experience with biologic drug manufacturing.

Understanding of general cGMP standards and practices.

Knowledge, Skills, Abilities

Working understanding of general cGMP standards and practices.

Understanding of process equipment and unit operations (Bioreactors, Chromatography, TFF, Autoclaves, media / buffer preparation, etc.) and associated process utility systems.

Comfortable supporting concurrent issues and working in an exciting and fast-paced environment.

High ethical standards to support a professional business code of conduct.

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!

Other

Relocation assistance is NOT provided.

Must be legally authorized to work in the United States now and in the future, without sponsorship.

Must be able to pass a comprehensive background check, which includes a drug screening.

The salary range estimated for this position based in Massachusetts is $103,100.00$154,700.00. 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 :

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.