Process Validation Specialist

ALTEN; Biel; Vor Ort; CHF 110.000 - 150.000; Vollzeit

Zusammenfassung

ALTEN is seeking a Process Validation Specialist to join the Manufacturing Sciences team and support validation activities for biotech processes in a GMP environment.

The role requires strong technical writing skills, 3+ years of process validation experience, and the ability to work independently within a cross-functional team, ensuring compliance with regulatory guidelines.

Qualifikationen

• Bachelor’s or Master’s degree in Life Sciences, Biotechnology, Chemistry, Engineering, or a related field.
• 3+ years of experience in process validation within a GMP pharmaceutical or biotech manufacturing environment.
• Strong experience in process validation within a GMP pharmaceutical or biotech manufacturing environment.
• Strong technical writing skills, with demonstrated experience authoring validation protocols and reports.
• Knowledge of upstream and/or downstream bioprocessing is preferred.
• Working knowledge of cGMP and validation lifecycle principles.
• Ability to work independently while supporting a broader validation team.

Aufgaben

• Support the execution of process validation studies for biotech manufacturing processes, ensuring adherence to cGMP and internal quality standards.
• Prepare, review, and finalize validation protocols, reports, and risk assessments with a focus on completing outstanding validation deliverables.
• Work closely with Manufacturing, Quality Control, Engineering, and MSAT teams to coordinate sampling activities, shop floor execution, and deviation investigations.
• Guarantee that all validation documentation complies with regulatory guidelines (e.g., FDA, EMA, ICH) and internal quality requirements.
• Contribute to Continued Process Verification (CPV) activities, including data analysis, trend monitoring, and process optimization.
• Assist with change controls, risk assessments, and CAPA (Corrective and Preventive Actions) related to validation activities.

Kenntnisse

Technical writing

Process validation

Regulatory knowledge

Problem solving

Cross-functional collaboration

Ausbildung

Bachelor’s or Master’s degree in Life Sciences, Biotechnology, Chemistry, Engineering, or a related field

Jobbeschreibung

We are seeking for a Process Validation Specialist to join our client's Manufacturing Sciences team and play a pivotal role in validating biotech processes. In this role, you will work as part of the Manufacturing Sciences team, providing hands‑on support for the execution and documentation of process validation activities.

If you thrive in a collaborative, fast‑paced GMP environment and have a knack for technical writing and problem‑solving, this opportunity is for you!

Key Responsibilities

• Support the execution of process validation studies for biotech manufacturing processes, ensuring adherence to cGMP and internal quality standards.
• Prepare, review, and finalize validation protocols, reports, and risk assessments with a focus on completing outstanding validation deliverables.
• Work closely with Manufacturing, Quality Control, Engineering, and MSAT teams to coordinate sampling activities, shop floor execution, and deviation investigations.
• Guarantee that all validation documentation complies with regulatory guidelines (e.g., FDA, EMA, ICH) and internal quality requirements.
• Contribute to Continued Process Verification (CPV) activities, including data analysis, trend monitoring, and process optimization.
• Assist with change controls, risk assessments, and CAPA (Corrective and Preventive Actions) related to validation activities.

Qualification and Experience

• Bachelor’s or Master’s degree in Life Sciences, Biotechnology, Chemistry, Engineering, or a related field.
• 3+ years of experience in process validation within a GMP pharmaceutical or biotech manufacturing environment.
• Strong experience in process validation within a GMP pharmaceutical or biotech manufacturing environment.
• Strong technical writing skills, with demonstrated experience authoring validation protocols and reports.
• Knowledge of upstream and/or downstream bioprocessing is preferred.
• Working knowledge of cGMP and validation lifecycle principles.
• Ability to work independently while supporting a broader validation team.