Process Validation Subject Matter Expert

vor 1 Monat

Lengnau, Schweiz Thermo Fisher Scientific Vollzeit

Thermo Fisher Scientific Inc. is a global leader in serving science with annual sales of more than $40 billion. Our mission is to help our customers make the world healthier, cleaner and safer. We support our customers advance life science research, solve complex analytical challenges, increase efficiency in their laboratories, improve patient health through diagnostics, or develop and manufacture life-enhancing therapies.

We are more than 100,000 colleagues to offer an unmatched combination of innovative technologies, convenient purchasing processes and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.

The brand new multi-purpose manufacturing and development site in Lengnau is designed for large scale biologics manufacturing and has high expansion potential. After completion of the construction phase, our Lengnau site will offer highly flexible biomanufacturing technologies, from process development to large-scale production, including stainless steel equipment, in order to successfully meet the needs of our customers.

Location: Lengnau

In this position, you will be responsible for the execution of Process Validation and ensure compliance to regulatory requirements and industry standards. The role establishes and maintains Validation Master Plans, Validation Protocols, Reports and supportive risk assessments and is accountable of the validation strategy definition. You will develop the scientific content relating to validation activities with an emphasis on risk-based, science-based approaches to Process Validation and to current Good Manufacturing Practices.

Your Responsibilities:

- Plan and perform validation studies for the Lengnau Site, currently for one dedicated bulk drug substance production line at a scale of 14,000 L bioreactor fed-batch processes including ancillary validation activities for recombinant protein manufacturing, Resin Lifetime Validation and Continuous Process Verification. The role will extent to additional suites of production.
- You will be responsible for the timely preparation of validation documentation, such as study protocols, sampling plans and generation of the validation reports.
- Manage the validation schedule and the coordination and execution of process validation activities including training of operations.
- Be a key contributor to issue resolution arising from validation activities in cooperation with Operations (e.g., deviation handling, change requests).
- Serve as the primary point of contact for our customers’ requests on process validation.
- Support regulatory inspections by presenting validation strategies (per products) and related validation documents.
- Interact with other sites validation teams through the global team, participate to global validation strategy definition and implementation, ensuring aligned approaches and knowledge exchange management.

Your profile:

- Degree (Bachelor, Masters or higher) in Life Sciences (Biology, Chemistry, etc.), Dipl. Ing. or M.Sc. or B.Sc. or equivalent
- Proven experience (7+ years of experience preferred) in process validation preferably gained within on a Life Sciences / Pharma / Biotech Upstream/Downstream/ manufacturing facility.
- A documented track-record and hands-on knowledge in biotech or pharmaceutical manufacturing processes.
- Fundamental understanding of biopharmaceutical analytical methods.
- Proven experience in cGMP and GxP and regulations and guidelines related to process validation.
- Language skills: English (Fluent) and German (beneficial)

Our offer:
You can expect a varied job in a dynamic and international environment. A culture in which integrity, intensity, involvement and innovation are lived. A well-founded induction and task-specific training are a matter of course for us. You will define your future in our company - make your contribution to our joint success

**Are you interested?**

Each of our 100,000 outstanding individuals at Thermo Fisher Scientific has a very personal story. Join us and contribute to our unique mission.

Thermo Fisher Scientific is committed to equal opportunity as an employer and does not discriminate on the basis of ethnicity, color, religion, sex, sexual orientation, gender identity, national origin, disability or legally protected status.

Agency notice

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