Tasks

- Lead (overall responsibility) for all Black Utilities Systems (e.g. HVAC-System, Steam-System, Cooling Water / Hot Water Systems, Potable Water & Sanitary Systems, Diesel System)
- Lead Commissioning & Qualification activities during different project phases (Design input, Support/execute IC, Execution Phase)
- Execution of the following activities for the relevant systems in accordance with Project procedures/guidelines: System Boundary development + approval and commissioning preparation, execution and approval
- Maintain control over the activities and schedule with respect to the relevant systems
- Function as a key member of the CQ Team, and provide guidance regarding Black Utilities Systems
- Actively participate in the development and delivery of deliverables with respect to the relevant systems
- Participate in sessions to define/agree work breakdown structure with respect to the relevant systems and assist in assessing project risk and evaluating the effectiveness of mitigation strategies applied
- Coordination and communication with other resources for Black Utilities Systems-related matters
- Assist in assessing project risk and evaluating the effectiveness of mitigation strategies applied

Qualifications

- Bachelor’s degree in Life Sciences or Engineering
- 6+ years of experience in commissioning / qualification / validation (DQ, IQ, OQ, Commissioning) activities in the pharmaceutical/biotech industry
- Proven Black Utilities knowledge
- 6+ years of experience in commissioning / qualification / validation of Black Utilities Systems
- Experience with DeltaV (Emerson) and with COMOS/KNEAT platforms
- cGMP knowledge and knowledge of regulatory requirements
- Able to work with minimum oversight fulfilling deliverables within target dates
- Fluent English language written and verbal communication skills, fluent German is a distinct preference