
Validator Expert
5 days ago
We are seeking a skilled professional to manage and execute validation activities, ensuring the successful delivery of validation projects. The ideal candidate will possess strong analytical, problem-solving, and organizational skills, as well as excellent communication skills and the ability to work in a team-oriented environment.
The Validation Engineer will develop and support the creation of validation documentation, apply a science-based approach to validation, analyze data, and assist with investigating deviations. Collaboration with cross-functional teams and adherence to safety, quality, and regulatory standards are key aspects of this role.
Key Responsibilities- Develop, execute, and document protocols (IQ, OQ, PQ) and reports for new qualification.
- Coordinate the completion of cleaning performance qualification.
- Investigate and resolve discrepancies/incidents arising from qualification activities.
- Perform Periodic review Site Validation Maintenance Program, ensuring systems remain in a validated state throughout their lifecycle.
- Support change control activities, ensuring proper validation assessments and documentation.
- Support other day-to-day validation activities, ensuring adherence to approved Validation SOPs, Plans, and Policies.
- Work closely with End-Users, Quality, and Engineering functions to ensure validation activities are completed as planned.
- Fair knowledge and experience of the practical and theoretical requirement of validation program in a GMP facility.
- Relevant experience in validation of facility, equipment, utility, cleaning, and/or sterilization.
- Familiarity with Regulatory requirements and Standards (e.g., FDA, EMEA, GAMP and ICHQ7).
- Ability to read and interpret technical documentation, system specifications, and validation protocols.
- Strong analytical, problem-solving, and organizational skills.
- Excellent communication skills and ability to work in a team-oriented environment.
- Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook).
- Willingness to learn and adapt in a fast-paced, regulated industry.
- Generous Leave Policy including 3 days to care for aging family members, reflecting our commitment to family wellbeing.
- Comprehensive Health & Wellness Coverage: Receive robust medical and dental coverage to support your health needs.
- Professional Development Opportunities: Access continuous learning programs and resources for career growth within the company.
- Inclusive Culture: Work in an environment where innovation, collaboration, and diverse perspectives are encouraged and celebrated.
- Shape the Future: Make a real difference in the pharmaceutical industry while advancing your career.
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