À propos
If you think you are the right match for the following opportunity, apply after reading the complete description.
The Validation Engineer will be responsible for the review, development, execution, and control of validation activities across all company projects. This role will support the full validation lifecycle, ensuring compliance with cGMP standards while working closely with project teams, validation consultants, and key stakeholders across the business.
Key Responsibilities
Validation Planning & Scheduling
- Evaluate validation requirements for new equipment, change controls, and evolving regulatory expectations
- Monitor project progress from a validation perspective, ensuring timely updates and alignment
- Support the preparation and maintenance of validation status reports, including monthly updates
- Work closely with Project Managers to ensure validation activities align with overall project timelines
Validation Standards & Compliance
- Assess current validation practices to ensure full compliance with cGMP requirements
- Stay up to date with industry developments and evolving validation standards
- Review and implement validation procedures, documentation, and reports in line with regulatory expectations
- Support the implementation of global and site-specific (including CSV) validation documentation
- Coordinate and support SDLC documentation activities
Validation Execution & Approval
- Execute validation protocols across a range of projects
- Review and approve validation protocols plant-wide
- Review and approve project change controls from a validation perspective
- Prepare validation documentation and reports as required
General Responsibilities
- Contribute to the ongoing development and improvement of company validation standards
- Support the growth and development of the validation function
- Act as a key point of contact during audits, presenting validation activities in a professional manner
- Support regulatory inspections and business partner queries as required
- Assist with xcfaprz validation initiatives and internal processes, including SLC activities
- Take on additional responsibilities as required in line with business needs
Key Requirements
- Experience in validation within a regulated environment (pharmaceutical or medical device preferred)
- Strong understanding of cGMP and validation lifecycle principles
- Experience with validation documentation, protocol execution, and change control processes
- Exposure to CSV and SDLC documentation is advantageous
- Strong stakeholder management and communication skills
- Ability to work across multiple projects in a fast-paced environment
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Compétences linguistiques
- English
Avis aux utilisateurs
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