CQV Lead (f/m/d) -Upstream Process Equipment
Key information
Publication date:
03 April 2024Workload:
100%Contract type:
Permanent positionLanguage:
English (Fluent)Place of work:
Region Waadt / Unterwallis
For Lonza SGIE AG in Visp we are looking für a CQV Lead 100% (f/m/d).
The CQV Lead Upstream is primarily responsible for the preparation and the execution of the CQV activities relating to Upstream Process Equipment.
Accountabilities
- Self-manage CQ development and execution activities with respect to the relevant systems.
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Function as a key member of the CQ Team, and provide guidance regarding Upstream Process Equipment
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Maintain control over the activities and schedule with respect to the relevant systems.
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Participate in sessions to define/agree work breakdown structure with respect to the relevant systems
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Assist in assessing project risk and evaluating the effectiveness of mitigation strategies applied.
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Coordination and communication with other resources for Upstream Systems-related matters.
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Adherence to project procedures/requirements with respect to Health/Safety/Environmental, Quality (including GDP/GMP), CQ (including MCP, MQP, DQ, IQ, OQ, Commissioning).
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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.
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Actively participate in the development and delivery of deliverables with respect to the relevant systems.
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Report on key deliverable and dates and align with key milestones within the project's critical path.
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Report and aid in the resolution of project issues, including maintaining the non-conformance records.
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Assist in assessing project risk and evaluating the effectiveness of mitigation strategies applied.
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Prioritize and execute tasks in a fast-paced environment.
Functie-eisen
- Minimum Bachelor's degree in Life Sciences or Engineering
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Minimum of 6+ years of experience in commissioning / qualification / validation (DQ, IQ, OQ, Commissioning) activities in the pharmaceutical/biotech industry.
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Proven Upstream system and CIP / SIP knowledge.
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Minimum 6+ years of experience in commissioning / qualification / validation of Downstream systems.
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Experience with DeltaV (Emerson).
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Fluent English language written and verbal communication skills.
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cGMP knowledge and knowledge of regulatory requirements.
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Able to work with minimum oversight fulfilling deliverables within target dates.