Position Summary
The Validation Technician provides essential support in validation activities across manufacturing and laboratory environments, ensuring that equipment, processes, and systems are effectively qualified for intended use and regulatory compliance.
Key Responsibilities
Validation Execution: Ensure that manufacturing and laboratory equipment, computer systems, cleaning, sterilization/sanitation processes, and manufacturing procedures are validated according to standards and schedules.
Requalification Management: Maintain responsibility for specific areas within the department’s requalification schedule, ensuring all processes remain in a validated state through certificates and regular reviews.
Documentation and Reporting: Author, review, and approve validation protocols and reports (including vendor-provided documentation) to meet established standards, both pre- and post-execution. Develop and update Standard Operating Procedures (SOPs).
Test Execution: Conduct test protocols, collect samples, record data and observations, perform calculations, and analyse results within cleanrooms across various manufacturing locations, producing comprehensive reports.
Workflow Management: Organize, prioritize, and deliver individual work schedules (routine and project-based), ensuring timelines and deadlines are met by adapting work patterns as needed.
Knowledge Sharing and Training: Provide training, advice, and best-practice guidance in validation topics to colleagues across departments, sharing expertise in team meetings, projects, and presentations.
Documentation Systems: Maintain familiarity with Validation department systems to ensure validation documentation is audit ready.
Compliance and Safety: Adhere to Good Manufacturing Practice (GMP) principles and Health & Safety guidelines in all activities, ensuring personal and team safety.
Additional Duties: Participate in training sessions, conferences, or supplier site visits as necessary, both domestically and internationally. Perform other tasks as requested by management.
Minimum Qualifications & Experience
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.
Preferred Qualifications & Experience
Degree in a relevant field is preferred.
Experience in GMP aseptic manufacturing.
Validation experience in areas such as equipment, facilities, computer systems, cleaning, processes, sterilization, sanitization, or temperature management.