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We are currently looking for a “Commissioning & Qualification (C&Q) Lead” to join a leading Drug Substance facility project based in the LOCATION area. As the Commissioning & Qualification (C&Q) Lead you will be responsible for overseeing the full lifecycle of C&Q for upstream and downstream bioprocess equipment. This high-impact role is situated within an international CAPEX environment, offering you the chance to make a significant contribution to a major project.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Commissioning & Qualification (C&Q) Lead will be varied however the key duties and responsibilities are as follows:
1. Lead the C&Q effort across a range of equipment including bioreactors, filtration systems, chromatography, formulation, and filling units.
2. Coordinate all related documentation such as QRA, DV, FAT, SAT, IOV, and summary reports.
3. Drive test execution, manage deviations, and oversee supplier activities.
4. Ensure project milestones are achieved safely and compliantly, with clear KPI reporting.
ROLE REQUIREMENTS:
To be successful in your application to this exciting role as the Commissioning & Qualification (C&Q) Lead we are looking to identify the following on your profile and past history:
1. Relevant degree in a technical engineering field.
2. Extensive industry experience in end-to-end C&Q on biotech/pharma CAPEX projects.
3. A working knowledge and practical experience with GMP (Annex 15), GAMP 5, ISPE, and ASTM E2500.
Key Words:
Commissioning & Qualification / C&Q Lead / Drug Substance / bioprocess equipment / CAPEX projects / GMP / GAMP 5 / ISPE / ASTM E2500 / biotech / pharma
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the Life Science sectors, combining recruitment expertise with scientific knowledge to help you advance your career.
We are currently looking for a “Commissioning & Qualification (C&Q) Lead” to join a leading Drug Substance facility project based in the LOCATION area. As the Commissioning & Qualification (C&Q) Lead you will be responsible for overseeing the full lifecycle of C&Q for upstream and downstream bioprocess equipment. This high-impact role is situated within an international CAPEX environment, offering you the chance to make a significant contribution to a major project.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Commissioning & Qualification (C&Q) Lead will be varied however the key duties and responsibilities are as follows:
1. Lead the C&Q effort across a range of equipment including bioreactors, filtration systems, chromatography, formulation, and filling units.
2. Coordinate all related documentation such as QRA, DV, FAT, SAT, IOV, and summary reports.
3. Drive test execution, manage deviations, and oversee supplier activities.
4. Ensure project milestones are achieved safely and compliantly, with clear KPI reporting.
ROLE REQUIREMENTS:
To be successful in your application to this exciting role as the Commissioning & Qualification (C&Q) Lead we are looking to identify the following on your profile and past history:
1. Relevant degree in a technical engineering field.
2. Extensive industry experience in end-to-end C&Q on biotech/pharma CAPEX projects.
3. A working knowledge and practical experience with GMP (Annex 15), GAMP 5, ISPE, and ASTM E2500.
Key Words:
Commissioning & Qualification / C&Q Lead / Drug Substance / bioprocess equipment / CAPEX projects / GMP / GAMP 5 / ISPE / ASTM E2500 / biotech / pharma
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the Life Science sectors, combining recruitment expertise with scientific knowledge to help you advance your career.
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the STEM sectors, combining recruitment expertise with scientific knowledge to help you advance your career.
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