CQV Engineer (Pharma/Biotech)

Share: Information

• Location: Berne, Switzerland
• Position: CQV Engineer (Pharma/Biotech)
• Sector: Life Science
• Type of contract: Permanent
• Starting date: Within 3 months

Agap2 is a European engineering and operational consulting group founded in 2005 and specialized in the industry. We work in the Life Science, Energy, Infrastructure, Transportation, Chemicals sectors.

As a consultant, you will have to support our clients in the realization of their projects on site by bringing your expertise and your skills.

You are agile and eager to adapt to different work environments that will fuel your curiosity of seeing what’s behind closed doors of the biggest projects of our client’s portfolio.

Your main missions are:

The CQV Engineer is primarily responsible for the preparation and the execution of the Commissioning & Qualification activities, including the following:

• Responsible for ensuring the milestone dates for commissioning and qualification are achieved
• Design Qualification preparation, execution and approval, including release for IQ.
• Commissioning preparation, execution and approval. Includes vendor supervision on their testing scope and quality.
• Installation & operational Qualification preparation, execution and approval. Including release for OQ / OPS.
• Provide support in execution of Design Qualification for other direct impact systems.
• Maintain control over the activities and schedule 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.

This job is made for you if...

• You hold a diploma in Life Sciences or Engineering, or similar
• You have 2 years minimum of experience in commissioning / qualification / validation (DQ, IQ, OQ, Commissioning) activities in the pharmaceutical/biotech environment
• You have a good knowledge of cGMP and regulatory requirements
• You are fluent in English & German

Working with us means...

• Joining a group with strong development potential that aims to improve your employability on challenging and varied projects
• Joining a structure that has been established in Switzerland for a long time with a client portfolio that includes the leaders in the sector
• Having a sustainable job with stability and access to a real collaboration
• Benefit from training with accredited and certified centers
• Having a local management to support you in the achievement of your missions and in the development of your career
• Being part of a dynamic, committed team with real human values that we live by every day

Only applications from Swiss and EU citizens will be considered. Please note that due to Brexit we are no longer accepting applications from the UK.