Pharmaceutical & Biotechnology
PE Global is currently recruiting for CQV Engineers for an initial 12-month contract with a leading multinational biopharmaceutical client based in Switzerland. Fully onsite roles.
There are 10 x CQV Engineer roles available, offering very lucrative rates.
The CQV Engineer is primarily responsible for the preparation and the execution of the CQV activities as per below responsibilities. Responsibilities (includes but is not limited to)
• Execution of the following activities for the relevant systems in accordance with Vibe-X Project procedures/guidelines:
o System Boundary development + approval.
o Design Qualification preparation, execution and approval. Includes release for IQ.
o Commissioning preparation, execution and approval. Includes vendor supervision on their testing scope and quality.
o Installation Qualification preparation, execution and approval. Includes release for OQ.
o 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 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
The list of the systems for which the CQV Engineer is responsible, depends on the assigned equipment group and will be shared with the holder of the position at job start. The equipment group for which the candidate will get assigned to, will be evaluated during the interview and will be communicated to the candidate with the job offer. The system scope for which the CQV Engineer will be responsible may evolve over time and may gets updated as the project progresses.
• Minimum Bachelor’s degree in Life Sciences or Engineering
• Minimum of 2+ years of experience in commissioning / qualification / validation (DQ, IQ, OQ, Commissioning) activities in the pharmaceutical/biotech industry.
• Proven Process or Utility Equipment experience (either DSP, USP, Bioconjugates or Clean Utilities)
• Minimum 2+ years of experience in commissioning / qualification / validation of Clean 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.
• Fluent German is a distinct preference.
• Experience with Lonza Commissioning / Qualification Approach.
• Experience with COMOS/KNEAT platforms.
Interested candidates should submit an updated CV.
Please click the link below to apply, call Paul Wheatley on 083 094 0199 or alternatively send an up-to-date CV to email@example.com
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***