CQV Area Lead HVAC

Main Responsibilities :

Lead (overall responsibility) for all HVAC systems. The following is a list of the systems for which the Commissioning & Qualification group is responsible :

HVAC-System, Relevant related HVAC systems

• Lead Commissioning & Qualification activities during the following project phases :
• Design input (URS, P&ID, process flows, COMOS data, etc.).
• Doc Prep (templates), DR FAT execution, Doc Prep, Doc Review
• Support / execute IC, Execution Phase Includes, but not limited to, 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.
• Provide support in the implementation of the Installation Commissioning process in accordance with Project procedures / guidelines.
• Shall be able to work / support another C&Q activity if deemed necessary.
• Carry out shift work, where required.
• Available for travel to vendors / contractors, were required.
• 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 Black Utilities 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 Black Utilities 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.

Qualifications and Experience :

• Relevant working / residency permit or Swiss / EU-Citizenship required
• 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 HVAC and relevant Clean / Black Utilities knowledge.
• Minimum 6+ years of experience in commissioning / qualification / validation of Black Utilities 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.

Nice to have :

• Fluent German is a distinct preference.
• Experience with Lonza Commissioning / Qualification Approach.
• Experience with COMOS / KNEAT platforms.
• Biopharmaceutical knowledge.
Vor 30+ Tagen