Process Validation Specialist
Company
Our client is a leading organization dedicated to advancing pharmaceutical manufacturing processes and ensuring compliance with industry standards. They prioritize quality, safety, and innovation to deliver the highest standards in their operations.
Job Description
We are seeking a skilled Validation Engineer to oversee and execute commissioning, qualification, and validation activities across equipment, utilities, and systems. The successful candidate will support the validation lifecycle, ensure compliant and efficient operations while work closely with cross-functional teams.
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, resolving any exceptional conditions that arise.
- Conduct investigations into deviations and implement corrective and preventive actions (CAPAs).
- Support calibration and certification activities for validation instruments.
- Review and approve technical documentation such as protocols, reports, test records, and SOPs related to validation.
- Create and maintain validation documents, including risk assessments, validation plans, user acceptance tests (UATs), and final reports.
- Collaborate with quality teams to establish validation strategies, standards, and procedures.
- Provide guidance on validation activities during project planning, design, and execution phases.
- Manage contractors involved in validation activities, ensuring compliance and timely completion.
- Develop or review technical specifications for validation of lifecycle documents.
- Support vendor protocol execution as needed.
- Perform other related tasks as assigned, delegating where appropriate.
Requirements
- MBO level 4 with a minimum of 6 years of relevant validation experience, or HBO with at least 4 years.
- Experience working within GMP environments in the pharmaceutical or comparable industries.
- Strong validation background, including knowledge of CSV and CQV processes.
Other Information
If you are interested and want to apply, please submit your application via the apply button below and contact me.
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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.
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