• Contract
  • Valais
  • Recruiter: Usha Rao

 

CQV Area Lead HVAC – 5615 URA

 

Our client, a global market leader in the production and process support of active pharmaceutical ingredients, both in the chemical and biotechnology sectors, is looking for CQV Area lead HVAC in Visp area for a 12 months contract (extension planned) based in the Valais area, Switzerland.

 

The CQV Area Lead role is primarily responsible for the preparation and the execution of the CQ activities relating to HVAC systems.

 

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.