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CQV Engineer (Downstream Process Engineering)
View: 190
Update day: 20-03-2024
Category: Executive management Production / Operation
Industry: Research Biotechnology Pharmaceuticals
Position: Entry level
Job type: Full-time
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Job content
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
- 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.
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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