Technical Validation Specialist
2 days ago
The Technical Validation Specialist role at Next Phase Recruitment is a critical position that ensures the effectiveness and reliability of our equipment, processes, and systems across manufacturing and laboratory environments. This involves validation activities to guarantee regulatory compliance.
Key Responsibilities- Develop and execute validation protocols for manufacturing and laboratory equipment, computer systems, cleaning, sterilization/sanitization processes, and manufacturing procedures in accordance with established standards.
- Maintain responsibility for specific areas within the department's requalification schedule, ensuring all processes remain validated through certificates and regular reviews.
- Author, review, and approve validation protocols and reports, including vendor-provided documentation, to meet established standards both pre- and post-execution.
- Conduct test protocols, collect samples, record data, and observations, perform calculations, and analyze results within cleanrooms across various manufacturing locations, producing comprehensive reports.
- Organize, prioritize, and deliver individual work schedules, routine, and project-based, ensuring timelines and deadlines are met by adapting work patterns as needed.
- Provide training, advice, and best-practice guidance in validation topics to colleagues across departments, sharing expertise in team meetings, projects, and presentations.
- Maintain familiarity with Validation department systems to ensure validation documentation is audit-ready.
- Adhere to Good Manufacturing Practice (GMP) principles and Health & Safety guidelines in all activities, ensuring personal and team safety.
- Effective problem-solving abilities with a methodical scientific approach.
- Ability to work independently and as part of a team.
- Skilled in documentation, test writing, and using test instruments and computer systems.
- Background in Science, Engineering, or a technical discipline with relevant certifications or experience.
- Familiarity with quality control and pharmaceutical GMP practices.
The estimated salary for this role is $65,000 - $85,000 per annum, depending on location and experience.
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