Job PharmaCell - Manager Quality Engineering and Logistics

You will be responsible for the coordination, supervision and execution of the main engineering activities of the equipment and infrastructure within PharmaCell’s GMP quality systems (operate EMS/ BMS). The activities will include installation, maintenance, calibration and qualification of lab and GMP-production equipment. You will work closely with the department managers and team members to ensure timely maintenance and (re-) qualification of equipment to ensure uninterrupted operation of the facility at all times with minimal downtime. Furthermore, you will have responsibility for warehousing and international logistics.

You have affinity with GMP guidelines and you like to work in a quality-oriented environment. A willingness to work flexible hours and perform on call duties when required is important.

• Arrange planning for preventive maintenance, calibration and re/-qualification activities internaly and with suppliers (first contact person for suppliers)
• Perform small engineering and maintenance activities by daily/ weekly/ yearly checking/ monitoring of the equipment status (e.g. testing power back-up system, first contact person for breakdown maintenance)
• Accurate documentation and control of maintenance, calibration and qualification activities on equipment according to GMP (logbooks, equipment management system (EMS), equipment dossier etc.)
• Operate the Building Management System (BMS) and associated installations; follow-up on alarms as main contact person (incl. schedule for TD). Main contact person for all operation activities related to BMS/ datalogger. Support in budget planning for engineering and maintenance activities
• Writing, reviewing and approval of qualification documents, user requirement specification (URS), qualification/ re-qualification report, Standard Operation Documents, training documents
• Assist in improvement of new processes and contribute in solutions for process bottlenecks with respect to equipment related activities
• Responsibility for warehousing (incoming and outgoing goods, inventory management) and international logistics (delivery of cell samples/vials to and from hospitals and client facilities).

• BSc. (HLO) in biotechnological/pharmaceutical engineering, or technical (MLO) degree with 5 years of experience.
• Experience with equipment qualification tasks (IQ, OQ, PQ), writing URS
• Experience with HVAC, water systems, alarm systems,data logging systems and basic biotechnology equipment (centrifuges, incubators, LAFC, pumps, balances etc.) is recommended
• Experience in working with GMP quality systems
• Prior experience with warehousing and logistics a plus
• Good proficiency in English
• Good knowledge in standard MS-Office products
• Good knowledge in process engineering,
• Good knowledge of equipment management systems and building management systems

Please contact Marianne Hellwig for details.

PharmaCell is an energetic, young company acting as a Contract Manufacturing Organization (CMO) in the area of cell therapy and regenerative medicine (tissue culturing). The company works with European and US-based biotechnology companies on clinical development projects and offers GMP and regulatory consultancy, cell culturing process development, fill and finish, QC-testing and GMP production services, as well as storage and distribution of clinical trial materials. The company is based in Maastricht (Netherlands), conveniently located at approximately 1 hour driving distance from Brussels, Antwerp, Cologne and Dusseldorf.

Can be obtained from Marianne Hellwig
Telephone:+31 43 3509910