Lead C&Q Engineer

CAI
Limerick, Munster, Ireland
Full Time, Contractor
On Site
Senior
0+
Bachelor Degree
Engineering Healthcare Life Sciences

Posted 5 months ago

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Excellent 4.7

Job summary

Seeking a Lead C&Q Engineer for a biopharma project responsible for overseeing commissioning and qualification activities on bioprocess systems, ensuring compliance with GMP and regulatory standards, managing resources, coordinating with vendors and teams, and providing leadership for complex biopharma systems.

Responsibilities

Lead the full lifecycle of Commissioning and Qualification activities for upstream and downstream bioprocessing systems on a large-scale biopharma project. Coordinate with cross-functional teams and vendors to ensure system readiness, regulatory compliance, and seamless handover to operations.

Qualifications

Bioprocess systems Bioreactors Commissioning & Qualification Concentration systems EMA regulations FDA regulations Filtration systems GMP regulations Project management Validation

Requires a degree in Engineering, Biotechnology, or Pharmaceutical Sciences with over 5 years of experience in CQV and validation. Must possess strong knowledge of GMP, FDA/EMA regulations, and hands-on experience with bioreactors and filtration systems.

English

Company

CAI
Pharmaceutical Manufacturing
Location
Limerick, Munster, Ireland
Website
cai.io

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Excellent 4.7
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