Cqv Lead Npi

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On behalf of a client based in Switzerland - PM Group are currently looking to hire a CQV Lead for NPI. The CQV Lead will be primarily responsible for the CQV assessment and implementation of changes due to New Product Introduction (NPI) scope - working closely with a small team of NPI Engineers.

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- Lead the CQV NPI team through three distinct phases are foreseen for this role:

- Review proposed Engineering Change Notices and perform Commissioning and Qualification Impact Assessment. Support the development of new CQV Lifecycle documents or the generation of new CQV lifecycle documents
- Support the FATs for new equipment. Support the Construction team and Engineering team with the scheduling and planning of installation - tie ins to systems in Commissioning phase,
- Support with the Commissioning and Qualification of New scope
- Execution of the following activities for the relevant systems in accordance with Project procedures/guidelines:

- System Boundary development + approval.
- Commissioning preparation, execution and approval. Includes vendor supervision on their testing scope and quality.
- Support the execution of the following activities for the impacted systems in accordance with ORCA Project procedures/guidelines:

- Design Qualification preparation, execution and approval. Includes release for IQ.
- GMP-RA’s.
- Commissioning preparation, execution and approval. Includes vendor supervision on their testing scope and quality.
- Installation Qualification preparation, execution and approval. Includes release for OQ.
- Operational Qualification preparation, execution and approval. Includes release to OPS.
- Self-manage CQ development and execution activities with respect to the relevant systems.
- Function as a key member of the CQ Team, and provide guidance regarding New scope.
- Maintain control over the activities and schedule with respect to the relevant systems.
- Participate in planning and schedule 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 New scope 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 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.

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- Minimum requirements:

- Minimum Bachelor’s degree in Life Sciences or Engineering
- Minimum of 6+ years of experience in commissioning / qualification / validation (DQ, IQ, OQ, Commissioning) activities in the pharmaceutical/biotech industry.
- Proven Process, CIP, and SIP knowledge.
- Minimum 6+ years of experience in commissioning / qualification / validation of Downstream systems.
- Experience with DeltaV (Emerson).
- 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.
- Preferred requirements:

- Fluent German is a distinct preference.
- Experience with ASTMe2500.
- Experience with COMOS/KNEAT platforms.
- Lead experience
- Biopharmaceutical knowledge.