Cqv Commissioning Engineer

2 weeks ago

Dublin, Ireland Dps Group Global Full time

Overview
We are seeking a contract CQV Engineer with proven experience in commissioning and qualification of equipment and utilities within a drug substance (DS) manufacturing environment.
The successful candidate will play a key role in delivering a fast-paced CQV program in compliance with GMP, project timelines, and regulatory expectations.
You will work independently and as part of a cross-functional CQV team to author and execute qualification protocols, manage deviations, and support system handover for GMP operations.
Responsibilities
Author and execute qualification protocols for equipment and utilities in a drug substance manufacturing environment.
Manage deviations and support system handover for GMP operations.
Collaborate with a cross-functional CQV team to drive a fast-paced CQV program in compliance with GMP, project timelines, and regulatory expectations.
Required Experience & Qualifications
5+ years of experience in commissioning, qualification, or validation roles in a pharmaceutical manufacturing environment.
Bachelor's degree in Engineering, Life Sciences, or related technical discipline.
Exposure to generation, execution and completion of validation documentation.
Familiar with impact assessing project requirements, risk assessing processes and implementing strategies for qualification plans.
Competent in working to tight deadlines and reporting updates to project managers and department supervisors.
Experience using temperature mapping systems and familiarity with CTU qualifications.
Previous experience working with autoclaves and sterilisation systems is a bonus.
Previous experience working with utility systems and processing systems in a commissioning environment is beneficial.
Relevant transferable skills from similar disciplines will be considered.
Strong knowledge of CQV best practices, ISPE Baseline Guides, GAMP 5, and ASTM E2500.
Experience working on capital projects from construction through to handover.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Quality Assurance, Engineering, and Science
Industries
Pharmaceutical Manufacturing and Biotechnology Research
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