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CQV Engineer (Downstream Process Engineering)

Employer
Proclinical Staffing
Location
Visp, Switzerland, Zermatt
Salary
Negotiable
Start date
14 Sep 2021
Closing date
28 Sep 2021

View more

Discipline
Manufacturing, Engineering
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

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.

#LI-SH

Company

At ProClinical we have one aim: to support life science companies in the many challenges they face while combatting unmet medical need worldwide.

Ageing populations, rare diseases, epidemics and the millions of patients without access to medication are just a few of the pressing issues that life science companies contend with. The industry is under increasing pressure to develop new and innovative ways to save and improve patients’ lives. 

ProClinical’s mission is to support their work by connecting life science companies with the highly skilled professionals they need to continue innovating. 

Internal recruitment and HR teams often struggle to continuously source skilled, experienced professionals to fill highly-specialised and niche roles. ProClinical combines a deep understanding of the industry with extensive candidate networks to provide both a technical and cultural fit for our life science partners.

 

Company info
Website
Telephone
0800 988 4437
Location
Eldon House
Eldon Street
London
EC2M 7LS
United Kingdom

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