Position: Entry level

Job type: Full-time

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Are you a CQV Engineer interested in working for one of the most interesting names in High-Tech Biopharmaceuticals?

Are you looking for something new?!

Title: CQV Engineer (Downstream Process Engineering)

Location: Visp, Switzerland

Rate: Open

Openings: 1 Engineer

Contract/Perm: Contract (12-Months)

A Fantastic new role has just opened up at one of our leading Swiss based clients offering the successful candidate the opportunity to join a hard-working team working on exciting projects in the pharmaceutical sector.

Responsibilities
  • Includes, but not limited to, execution of the following activities for the relevant systems in
  • accordance with ORCA Project procedures/guidelines:
  • System Boundary development + approval.
  • 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.
  • Provide support in execution of Design Qualification for other direct impact systems.
  • Provide support in the implementation of the Installation Commissioning process in accordance with Project ORCA 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 Downstream Buffer + Filtration 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 Downstream Buffer + Filtration Systems-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
Requirements
  • Minimum Bachelor’s degree in Life Sciences or Engineering
  • Minimum of 6+ (Lead) / 4+ (Senior) / 2+ (Intermediate) years of experience in commissioning / qualification / validation (DQ, IQ, OQ, Commissioning) activities in the pharmaceutical/biotech industry.
  • Proven Upstream system, CIP, and SIP knowledge.
  • Minimum 6+ (Lead) / 4+ (Senior) / 2+ (Intermediate) years of experience in commissioning / qualification / validation of Upstream 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.
  • Fluent German is a distinct preference.
  • Experience with Lonza Commissioning / Qualification Approach.
  • Experience with COMOS/KNEAT platforms.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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Deadline: 04-05-2024

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