About the company
Our client is a global organization operating in a highly regulated pharmaceutical manufacturing environment. The site supports complex production and packaging operations and is committed to quality, compliance, and continuous improvement across engineering and validation activities.
About the role
As a CQV Engineer, you will support engineering and technical projects within a GMP environment, focusing on commissioning, qualification, and validation of manufacturing and packaging systems. You will develop and execute CQV strategies, lead testing activities, and ensure systems are compliant with regulatory and internal quality standards. The role operates with a high degree of autonomy while being closely aligned with site engineering and validation stakeholders.
What you’ll do
- Develop, update and maintain CQV documentation such as system criticality assessments, CQV plans, risk assessments, test protocols, requirement traceability matrices and summary reports
- Lead and execute commissioning, qualification and validation activities for manufacturing and packaging systems
- Provide validation and technical guidance to project teams to ensure solutions are implemented according to validation plans and site procedures
- Support project execution across multiple phases including design, implementation, testing, commissioning and validation
- Ensure GMP compliance and alignment with internal procedures throughout all project activities
- Identify risks, manage priorities and escalate issues to ensure timely project delivery
What you’ll bring
- Minimum of 3 years of hands-on experience in Commissioning, Qualification & Validation within the pharmaceutical industry
- Experience with secondary packaging systems, including print and inspection systems
- Proven experience with Computerized Systems Validation (CSV)
- Solid understanding of GMP requirements, validation practices and regulated manufacturing environments
- Strong technical writing skills in English
- Ability to work independently while managing multiple activities in parallel
- Strong communication skills and the ability to collaborate with cross-functional stakeholders
- Analytical mindset with strong problem-solving and critical thinking capabilities
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About us
Since 2012, SIRE Life Sciences is the most innovative and engaged consultancy company for the life sciences industries.
SIRE Life Sciences is proud of its ability to adapt to changing trends while always maintaining the highest level of quality for both our clients and our candidates.
Our team of knowledgeable professionals provides customized staffing services to clients and candidates, including secondment, direct hire, temporary-to-hire, temporary staffing, brokering, Statement of Work and we approach each type with the same degree of professional assessment. Our refined and collaborative style is unmatched in the staffing industry. We’re able to see beyond the surface to create matches that result in successful careers for our candidates and valuable talent for our clients.
Effective employment solutions need to put the right person in the relevant place every time, using advanced systems to streamline costs and time-frames for clients.