Job Description
Job Title: Validation Technician
Department: Validation
Reports to: Validation Manager
Position Summary
The Validation Technician plays a crucial role 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
* Execution of Validation: Ensure that manufacturing and laboratory equipment, computer systems, cleaning, sterilization/sanitization 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 analyze 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.
Estimated Salary: $70,000 - $90,000 per year.