The Company
Our client is a global leader in advanced cell therapy, specializing in developing and delivering cutting-edge treatments for patients with serious illnesses. The organization operates state-of-the-art manufacturing facilities and follows the highest GMP standards to ensure quality and safety.
Role Description
As a Validation Engineer you will responsible for executing commissioning, qualification, and validation activities for equipment, utilities, facilities, and computerized systems in a GMP-regulated pharmaceutical environment. The role supports the full validation lifecycle, including protocol development and execution (IQ/OQ/PQ), deviation management, CSV documentation, and coordination with Quality, Engineering, and external contractors to ensure compliance and inspection readiness.
Responsibilities
- Perform routine commissioning, qualification, and validation (CQV) tasks, including temperature mapping and related validation activities.
- Develop and execute validation protocols for equipment, utilities, facilities, and computerized systems, including IQ, OQ, PQ, and validation plans.
- Investigate deviations and exceptional conditions, implementing corrective and preventive actions (CAPAs) to resolve issues.
- Assist with calibration and certification of validation instruments to maintain accuracy and compliance.
- Review and approve technical documentation such as protocols, summary reports, test records, and validation SOPs.
- Create and maintain Computerized System Validation (CSV) documents like risk assessments, validation plans, user acceptance tests (UATs), and final reports.
- Collaborate with Quality Engineering to establish and update validation strategies and standard procedures.
Requirements
- MBO level 4 with at least 4 years of relevant experience, or HBO with at least 3 years of experience.
- Proven GMP experience within the pharmaceutical or related industries.
- Prior validation experience in a regulated environment.
Other Information
Apply to our vacancy for more information. looking forward to hearing from you.
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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.
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