Equipment Engineer General / USP LVV

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

We are looking for an Equipment engineer for general equipment (fridges, freezers, TSCUs) and Upstream Processing (USP) LV Operations with who will strengthen our team of specialists with knowledge and expertise of TSCUs, Cell culturing, Wave bioreactors, Single use Bioreactors, Shaker flask incubation and Cell counts.

As Equipment engineer you ensure that we meet the unmet needs of today by supporting the operations in making operational processes safer, easier, simpler and more stable. In this role you act as system owner, in which you are the first responsible person to perform acute troubleshooting and support of cGMP batches in the LV Operations. As system owners we enable operations to process first time right with our equipment and guidance. This varies from qualifications of the systems and processes, initial training, writing procedures and instructions till working together in project teams. We enable Operations to excel in production reliability through continuous innovation.

Besides this you will be playing a key role in the further development of the Business Unit in terms of new product introduction, efficiency, and reliability. The duties of the Equipment Engineer general and USP include:

You will be responsible for:

• Manage and use the business processes, with which the equipment performance is analyzed and makes proposals for improvement points with the greatest impact on a specific objective (safety, quality, reliability/efficiency and costs).
• Identify, plan and control changes for system and process robustness (team task allocation and prioritization 0-3 months timeframe);
• Lead/owner business processes and projects that are mainly system or facility related, with peers in service oriented or operating departments.
• Ensures that the production equipment is in validated state, documentation is up to date, well maintained, and production capacity meets planning.
• Will play a key role in the interaction between our Operation Department on one site and the Maintenance and Engineering teams including the other sites.
• Generate the process equipment related reports and KPIs. You will have the overview and knowledge of the status of the equipment (e.g. uptime, downtime, breakdowns, lifecycle management, occupancy rate and capacity).
• Initiate and execute test protocols that help to improve the system or process.

Qualifications/Requirements

• Bachelor's degree in biotechnology, biochemistry, biomedicine, process technology (or equivalent education).
• Manufacturing specialist 3-4 years' experience in a biotechnology or biopharmaceutical industry environment.
• Proven knowledge in the following aspects: Fridges / freezers (TSCUs) Cell culturing, Incubators, Single Use Bioreactor control.
• Experience with cGMP environment and EHSS standards is required.
• Experience with Annex 1 guidelines is preferred.
• Able to perform trouble shooting 24/7 every 4 weeks.
• Positive attitude, proactivity, decisive, and organized with an ability to work individually and in a team.
• Excellent communication skills, written and verbal in English (B2 required) and Dutch (pre)

Preferred Skills

• Agile Manufacturing, Analytical Reasoning, Analytics Dashboards, Business Behavior, Chemistry, Manufacturing, and Control (CMC), Communication, Data Analysis, Data Compilation, Data Savvy, Execution Focus, Gap Analysis, Good Manufacturing Practices (GMP), Manufacturing Standards, Operational Excellence, Plant Operations, Process Optimization, Project Administration, Technical Credibility