Senior Process Expert Aseptic Filling​/Isolator Technical Writing

Job Title: Sterility Assurance Expert - Fill & Finish / Isolator Technical Writing

Company: Inova ((Use the "Apply for this Job" box below).)

Contract Type: Full-time – On-site

Start Date: ASAP

We are seeking a Sterility Assurance Expert / Fill & Finish to support a pharmaceutical client in the Basel area, with a strong focus on technical writing and operational documentation for aseptic manufacturing activities. This role is particularly focused on isolator-based operations and will involve the creation, review, and improvement of GMP documentation such as SOPs, Work Instructions, training materials, and process-related documentation for activities including compounding, smoke studies, media fills, PQ phases, and routine fill & finish operations.

The ideal candidate combines deep hands‑on process expertise with the flexibility and precision required to write clear, compliant, and operationally relevant documentation for manufacturing teams.

• Write, review, and update GMP documentation related to fill & finish and aseptic processing activities
• Develop SOPs, Work Instructions, training materials, and operational guidance documents
• Support documentation for compounding, isolator operations, smoke studies, media fills, and PQ phases
• Translate hands‑on process knowledge into clear, practical, and compliant procedures
• Work closely with Manufacturing, MSAT, QA, Engineering, and Validation teams
• Support preparation and execution documentation for process qualification and aseptic process simulations
• Ensure documentation is aligned with GMP expectations, internal standards, and operational best practices
• Contribute to training readiness by preparing clear and structured training content for operators and technical teams
• Provide senior process expertise while remaining hands on and flexible in document execution activities
• Support start‑up, remediation, or improvement activities related to isolator‑based fill & finish operations

• Degree in Life Sciences, Pharmaceutical Sciences, Engineering, or a related technical discipline
• 10+ years of experience in pharmaceutical manufacturing, with strong expertise in fill & finish / aseptic processing
• Solid hands‑on experience with isolator-based operations
• Strong knowledge of GMP requirements for sterile manufacturing environments
• Experience with compounding, smoke studies, media fills, PQ phases, and aseptic process documentation
• Proven ability to write high‑quality SOPs, Work Instructions, training materials, and technical GMP documents
• Senior profile with the flexibility to perform detailed technical writing activities
• Strong collaboration skills and ability to interact with shopfloor, QA, Engineering, Validation, and Manufacturing teams
• Fluent in English;
  German is a plus
• Available to start ASAP in the Basel area

Inova is an equal opportunity employer. We welcome diverse perspectives and are committed to fostering an inclusive workplace.