• Contract
  • Valais
  • Recruiter: TargetRecruit Admin

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CQV Lead – New Product Introduction – 5385

Our client is looking for a CQV Lead – New Product Introduction to be responsible for the CQV assessment and implementation of changes due to New Product Introduction (NPI) scope. The Lead will be supported by 2 CQV NPI engineers. This role is an initial 15 months contract with extension to be based in Valais.

 

Main Responsibilities

  • 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.

  

Qualifications and experience:

·      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 and fluent German is a plus

·      cGMP knowledge and knowledge of regulatory requirements.

·      Able to work with minimum oversight fulfilling deliverables within target dates.

·      Experience with ASTMe2500.

·      Experience with COMOS/KNEAT platforms.

·      Lead experience

·      Biopharmaceutical knowledge.

Would you like to learn more about CTC and the opportunity outlined? Please, get in contact with us: you may either use the 'apply now' button, or write an email to us, or reach out to us on the phone.

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