Senior Validation Specialist, Haarlem, Noord-Holland

The Company
A leading organization in the pharmaceutical sector, committed to maintaining the highest standards of quality, compliance, and operational excellence. They focus on innovative solutions and continuous process improvements to ensure the delivery of safe and effective healthcare products.

Role Description
We are seeking a skilled Senior Validation Engineer to join our client’s team. In this role, you will lead and oversee validation activities across various manufacturing equipment and systems, ensuring compliance with regulatory and Quality standards while supporting operational efficiency and product quality.

Responsibilities
- Lead and execute qualification activities for equipment, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Support validation protocols and plans for re-qualifications of sterilizers, autoclaves, lyophilizers, depyrogenation tunnels, and other manufacturing utilities.
- Document deviations, coordinate corrective actions, and ensure timely closure of issues.
- Provide technical guidance and expertise on validation-related topics to project teams and stakeholders.
- Collaborate with cross-functional teams to align validation activities with production schedules and project timelines.
- Perform risk assessments and impact analyses related to validation activities, proposing mitigation strategies as needed.
- Review and assess validation data, deviations, and change controls to ensure compliance with regulatory and internal quality standards.
- Prepare and evaluate periodic review reports.
- Ensure validation activities adhere to GMP and documentation best practices.
- Support internal and external audits and inspections as a subject matter expert, effectively communicating with regulatory authorities.
- Mentor and train junior validation team members, promoting knowledge sharing and best practices.

Requirements
- Bachelor's degree or higher in a scientific or engineering field.
- At least 4-5 years of experience in validation or change control within the pharmaceutical industry.
- Strong knowledge of GMP principles and validation methodologies, including V-Model and SDLC.
- Excellent problem-solving, organizational, and project management skills.
- Detail-oriented team player with a proactive, can-do attitude.
- Effective communicator, able to collaborate with multidisciplinary teams and communicate technical information clearly.

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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