Equipment Engineer, Biotech USP & cGMP Operations

360Pharma; Sassenheim; On-site; EUR 65,000 - 90,000; Full time

Job summary

360Pharma in the Netherlands seeks an Equipment Engineer to support general equipment (fridges, freezers, TSCUs) and Upstream Processing LV Operations. You will act as system owner, troubleshoot cGMP batches and ensure equipment is validated, with up-to-date documentation and reliable performance.

You will lead improvements, manage changes, and collaborate with Operations, Maintenance and Engineering across sites to enhance safety, quality and efficiency.

Qualifications

• Bachelor's degree in biotechnology, biochemistry, biomedicine or process technology (or equivalent).
• 3–4 years of manufacturing experience in biotech/biopharma.
• Knowledge of fridges/freezers (TSCUs), cell culturing, incubators and single-use bioreactors.
• Experience with cGMP environment and EHSS standards; familiarity with Annex 1.
• Willingness to perform 24/7 troubleshooting on a rotational basis; strong communication in English (B2) and Dutch (basic).

Responsibilities

• Ensure production equipment is validated, documentation is up to date, well maintained and production capacity meets planning.
• Identify, plan and control changes for system and process robustness.
• Lead/owner system- or facility-related projects in collaboration with operations and maintenance teams.
• Generate process equipment reports and KPIs; monitor uptime, downtime, lifecycle and capacity.
• Support interaction between Operations and Maintenance/Engineering across sites.

Skills

Troubleshooting

English Proficiency

Teamwork

Communication

Education

Bachelor's degree in biotechnology/biochemistry/biomedicine/process technology

Tools

Fridges/Freezers (TSCUs)

Single-Use Bioreactors

Incubators

Wave Bioreactors

Job description

360Pharma in the Netherlands seeks an Equipment Engineer to support general equipment (fridges, freezers, TSCUs) and Upstream Processing LV Operations. You will act as system owner, troubleshoot cGMP batches and ensure equipment is validated, with up-to-date documentation and reliable performance.

You will lead improvements, manage changes, and collaborate with Operations, Maintenance and Engineering across sites to enhance safety, quality and efficiency.