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Beschrijving vacature
About the Role
STRIKEBOX is an Irish SME specializing in the design and manufacture of stainless steel and plastic systems for the bioprocessing industry. We are seeking an experienced Fill-Finish Specialist to support process design, system validation, and technology development for aseptic filling and packaging operations.
Key Responsibilities
- Lead or support the design, optimisation, and validation of aseptic fill-finish processes, including filling, stoppering, and sealing operations.
- Provide technical expertise in aseptic techniques, contamination control, and GMP-compliant operations.
- Collaborate with the R&D and engineering teams on the development and testing of the Fill Finish systems, including prototype evaluation and process integration.
- Support equipment qualification (IQ/OQ/PQ) and preparation of validation documentation.
- Troubleshoot process deviations and propose continuous improvement solutions.
- Ensure compliance with certified standards.
- Train operators and technicians on aseptic process best practices.
- Contribute to customer trials, FAT/SAT activities, and technology transfer projects.
Functievereisten
Qualifications & Experience
- Bachelor’s degree in Bioprocessing, Biotechnology, Mechanical/Process Engineering, or a related field.
- Minimum 3+ years’ experience in aseptic filling, sterile manufacturing, or pharmaceutical process development.
- Strong understanding of GMP, aseptic techniques, and fill-finish equipment operation.
- Experience with liquid filling, vial/syringe systems, or single-use technologies is highly desirable.
- Familiarity with validation protocols, cleanroom environments, and barrier systems (Isolators/RABS).
- Excellent problem-solving, documentation, and communication skills.
