QA Validation Expert

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving sophisticated analytical challenges, growing efficiency in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our distributed team of more than 100,000 colleagues delivers an outstanding combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.

The state-of-the-art multi-purpose manufacturing facility is crafted for large-scale production of biologics and has high expansion potential. After completion of construction activities, our site in Lengnau will offer highly flexible biomanufacturing technologies, from development to large-scale production including stainless steel equipment to meet our customer needs.

**QA Validation Export**

**Location: Lengnau**

As a **QA Validation Expert** you are part of the Quality Management team at our new Lengnau facility. In this position you are playing a meaningful role for the start-up and successful licensure of our facility. Your core responsibility lies in the establishment of validation concepts and acceptance criteria of Steaming in Place Processes (SIPs) and qualification of autoclaves.

During ramp up of the facility, the role plays an active part in ensuring Quality oversight of qualification and validation activities as well as meeting the demanding project achievements.

**Your responsibilities**:

- You will have quality oversight of all steaming in place processes (SIPs) and qualification of autoclaves driven in Lengnau site.
- You are responsible to set up the overall strategy for Validation activities of SIPs and qualification of autoclaves performed during initial qualification and will ensure the deployment of the requalification program. For Steaming-In-place, autoclave, microbial process control and Equipment Hold Time,
- Develop the overall qualification and validation concepts, establish acceptance criteria and generate associated risk assessment as SME (Subject Matter Expert).
- You ensure the review and approval as quality function for protocols, reports, procedures and other relevant documents required for qualification & validation, re-qualification and routine operation in scope of the QM Validation Expert.
- Actively supply to implementation of Lifecycle Validation concepts at Lengnau and act as the Subject Matter Expert for the area of responsibility to health authority inspections and customer audits.

**Your qualification**:

- Validated experience (at a minimum 3 years) in sterilization by moist heat, dry heat, depyrogenation processes gained on a Life Sciences / Pharma / Biotech manufacturing facility.
- Validated experience in Project implementation starting from design phase until the end of the qualification and submission.
- Deep knowledge of cGMP including current knowledge of industry mentorship documents and standards focusing sterilization processes.
- Able to work collaboratively with others to ensure successful outcomes.
- Able to work well both independently and in a functional management/oversight role to ensure successful outcomes
- Excellent time management skills, with the flexibility to handle changing priorities and multiple tasks.

**We offer** driven 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 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve sophisticated scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Agency note