Our client, an innovative and dynamic bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, committed into delivering products on the market over the next 5 years, is looking for an:
Equipment & Utilities Maintenance Engineer – 5556 (ADA)
This is an initial contract for 12 months, based in Basel, Switzerland, with a high possibility of an extension.
You will be working within Facility Compliance, which is a supportive function for clinical manufacturing units for Solids (CMU1) and Sterile, liquids and semi-solids (CMU2). Facility compliance team works in close collaboration with operations personal tying manufacturing processes to compliance requirements.
The role and responsibility of the Equipment & Utilities Maintenance Engineer is to ensure operational readiness for equipment, and installations for Clinical Manufacturing in time and in full compliance with cGMPs requirements, which includes planning, coordination, execution, reporting of activities for:
· Equipment and utilities maintenance, diagnoses, repair or modification under cGMP standard and in line with client's procedures.
· Record, Documentation of interventions within client's Quality system (Change management, actions, deviations).
· Establish maintenance plans for equipment and utilities.
· Order parts and components for jobs as needed. Controls spare parts inventory for new and existing equipment. Prepares purchase requisitions for service vendors, maintenance supplies and spare parts. Review invoices.
· Point of contact for internal and external issues relating to Clinical Manufacturing Units equipment and systems.
· Write, review, maintain, facility and equipment standard operating procedures (SOPs) including cleaning validation, health and safety concepts.
· Support Management of Health and safety system. Including emergency shower, eye wash and fire extinguisher maintenance and inspection.
Qualifications and Experience:
- Relevant Swiss working/residency permit and/or Swiss/EU-Citizenship required;
- Bachelor’s or Master’s degree in technical, electrical and Mechanical engineering.
- Minimum 2 years of experience in Pharmaceutical Industry manufacturing environment.
- Experience and knowledge of computerized systems.
- Expertise in cGMP drug product manufacturing and control as well as pharmaceutical safety procedures
- Skilled to collaborate with professionals effectively.
- Well-developed planning and organization skills.
- Good communication and team working skills.
- Fluent in English (German and French an advantage).