CQV Lead (f/m/d) -Upstream Process Equipment

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.

• Function as a key member of the CQ Team, and provide guidance regarding Upstream Process Equipment

• 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 Upstream Systems-related matters.

• Adherence to 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.

• 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 Upstream system and CIP / 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.