CQV Engineer: Solid Dosage GMP Commissioning Lead

Life Science Recruitment; Athlone; On-site; EUR 90,000 - 120,000; Full time

Job summary

Life Science Recruitment advertises an exciting CQV Engineer role in Athlone within an award-winning pharmaceutical organization. The role focuses on life cycle qualification documentation for process equipment in a solid dosage environment and requires leadership of commissioning activities.

The candidate will manage CQV strategy, schedule, quality, safety and compliance across commissioning lifecycle, and will have a minimum of seven years in pharma commissioning with strong risk-based

Qualifications

• Degree in Engineering, Science or related discipline.
• Minimum 7 years GMP experience in pharma commissioning.
• Proven track record managing commissioning partners and contractors.

Responsibilities

• Develop and own CQV activities aligned to project schedule and GMP requirements.
• Act as Client C&Q Lead for the project.
• Coordinate all CQV activities and serve as single point of contact for CQV interfaces.
• Plan and lead system commissioning and qualification of equipment per schedule.
• Oversee and coordinate commissioning sub-contractors and partners.
• Interface with Quality, Manufacturing, EHS, QC and other stakeholders.
• Provide CQV status reporting to Senior Project Manager and governance forums.
• Manage risk registers and mitigation for the CQV lifecycle.
• Support turnover activities and handover to CQV and Operations with documentation.

Skills

CQV

Commissioning

Qualification

Validation

GMP

Stakeholder mgmt

Education

Engineering degree

Science degree

Job description

Life Science Recruitment advertises an exciting CQV Engineer role in Athlone within an award-winning pharmaceutical organization. The role focuses on life cycle qualification documentation for process equipment in a solid dosage environment and requires leadership of commissioning activities.

The candidate will manage CQV strategy, schedule, quality, safety and compliance across commissioning lifecycle, and will have a minimum of seven years in pharma commissioning with strong risk-based