Bioprocess Engineer

Barrington James; Genf; Vor Ort; CHF 90.000 - 120.000; Vollzeit

Zusammenfassung

Barrington James is seeking a Bioprocess Engineer for an 8-month on-site contract in Visp, Switzerland. The role focuses on reviewing and clearing a backlog of executed batch records and related GMP documentation, while supporting deviations, CAPAs, and change controls within a GMP framework.

Ideal candidates will have 3–4+ years in biopharma, German-language batch review experience, and Downstream Processing exposure, with hands-on DP and compliance activities.

Qualifikationen

• 3–4+ years in biopharma manufacturing or bioprocessing.
• Experience reviewing batch records in GMP.
• Fluent German; must review German batch docs.
• Experience with DP, CAPA, and change control.
• Aseptic fill-finish experience is desirable.

Aufgaben

• Review and clear executed batch records and GMP docs.
• Backlog clearance during first three months.
• Identify discrepancies and address missing information.
• Support deviations and CAPAs, heavy on documentation.
• Assist DP manufacturing and process activities.
• Coordinate change controls in GMP environments.
• Support autoclave and washing processes.
• Collaborate with manufacturing, QA and cross-functional teams.
• Ensure GMP compliance across activities.

Kenntnisse

GMP documentation

Batch records review

Deviation management

CAPA & change control

Downstream Processing

Autoclave processes

Cross-functional collaboration

Documentation discipline

Jobbeschreibung

Working Pattern: Full-time, 5 days per week on site

An exciting opportunity has arisen for a Bioprocess Engineer to join a biopharmaceutical manufacturing organisation in Visp on an initial 8‑month contract.

The successful candidate will support GMP manufacturing activities, with an initial focus on reviewing and clearing a backlog of executed batch records and associated documentation.

This is a hands‑on role suited to an organised and structured bioprocess professional who is comfortable working within a GMP manufacturing environment and managing documentation, deviations, CAPAs and change activities.

Key Responsibilities

• Review and assess executed batch records and associated GMP documentation.
• Support the clearance of an existing batch record/documentation backlog, particularly during the first three months.
• Identify documentation discrepancies, errors and missing information and ensure these are appropriately addressed.
• Support deviation and CAPA activities, with approximately 80% of the role focused around documentation/deviation‑related activities.
• Support manufacturing and process‑related activities within Downstream Processing (DP).
• Manage and coordinate change controls within a GMP environment.
• Support activities relating to autoclave and washing processes.
• Work closely with manufacturing, QA and other cross‑functional teams to ensure documentation and processes remain compliant.
• Ensure all activities are completed in accordance with GMP and relevant quality standards.

Requirements

• Approximately 3–4+ years of experience within biopharmaceutical manufacturing, bioprocessing or a related engineering function.
• Strong experience reviewing executed batch records within a GMP environment.
• Fluent German language skills are essential, due to the requirement to review German‑language batch documentation.
• Experience within Downstream Processing (DP).
• Experience with GMP documentation and deviation management.
• Good understanding of CAPA and change control processes.
• Aseptic fill‑finish experience is highly desirable.
• Experience with autoclave and washing processes is advantageous.
• Strong organisational skills with a structured and detail‑oriented approach.
• Clear communication skills and the ability to work effectively with cross‑functional stakeholders.

Ideal Candidate

The ideal candidate will be someone who is organised, methodical and comfortable working through large volumes of GMP documentation. You should be able to identify issues within executed batch records, understand their impact and work with the relevant teams to resolve them.

This is particularly suited to someone with hands‑on manufacturing, MSAT, process engineering or batch documentation experience who is comfortable working fully on site in Visp.

German language capability and relevant batch record experience are key requirements for the position.