Beschreibung
Job Title: Lead CQV Engineer Lab SystemsLocation: Switzerland
Duration: 12 months
The client manufactures a wide range of products for the pharmaceutical, agrochemical, electronics and aerospace industries and is developing a new biomanufacturing complex at its biopark. The site is the biggest site and hosts the majority of its manufacturing and research and development (R&D) operations.
Main responsibilities
The CQ Engineer role (Lab + Small Equipment Systems) is primarily responsible for the preparation and the execution of the CQ activities relating to Lab + Small Equipment Systems:
- Function as a key member of the CQ Team, and provide guidance regarding Lab + Small Equipment Systems
- Self-manage CQ development and execution activities with respect to the relevant systems
- Maintain control over the activities and schedule with respect to the relevant systems
- Participate in sessions to define/agree work breakdown structure with respect to the relevant systems
- Assist in assessing project risk and evaluating the effectiveness of mitigation strategies applied.
- Coordination and communication with other resources for Lab + Small Equipment Systems-related matters.
- Adherence to ORCA project procedures/requirements with respect to Health/Safety/Environmental, Quality (including GDP/GMP), CQ (including MCP, MQP, DQ, IQ, OQ, Commissioning).
- Liaise closely with the relevant vendors/providers/contractors, project Automation/CSV representatives and Construction-phase representatives to ensure integration of activities and schedules with respect to the relevant systems.
- Actively participate in the development and delivery of deliverables with respect to the relevant systems.
- Report on key deliverable and dates and align with key milestones within the project's critical path.
- Report and aid in the resolution of project issues, including maintaining the non-conformance records
- Assist in assessing project risk and evaluating the effectiveness of mitigation strategies applied.
- Prioritize and execute tasks in a fast-paced environment
Qualification & Experience Requirements
- Minimum Bachelor's degree in Life Sciences or Engineering
- Minimum of 2 - 6 years of experience in commissioning / qualification / validation (DQ, IQ, OQ, Commissioning) activities in the pharmaceutical/biotech industry
- Proven Lab + Small Equipment Systems knowledge.
- Minimum 6+ (Lead) / 4+ (Senior) / 2+ (Intermediate) years of experience in commissioning / qualification / validation of Lab + Small Equipment Systems.
- Experience with DeltaV (Emerson). O
- Fluent English language written and verbal communication skills.
- cGMP knowledge and knowledge of regulatory requirements.
- Able to work with minimum oversight fulfilling deliverables within target dates
Key Performance Indicators
- Experience with Commissioning / Qualification Approach.
- Experience with COMOS/KNEAT platforms.
- Experience with DeltaV (Emerson)
- Biopharmaceutical knowledge.
- Fluent German is a distinct preference
If you are interested in discussing further details about this or similar positions,
kindly contact me as soon as possible.
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Sthree Switzerland is acting as an Employment Business in relation to this vacancy.