Job Description
- Key Responsibilities
- Preparation and execution of qualification protocols and related documents (risk management, periodic reviews, URS, FRS, IQ, OQ, PQ, PV, FAT, etc.) to support the following:
- Prepared Media Manufacturing, testing and Packaging Equipment
- Facilities / Utilities
- Process Validation
- Laboratory instruments
- Software programs
- Spreadsheet validation
- Transportation validation
- Re-qualification of existing equipment and utilities
- Assisting system owners with impact assessments and identifying qualification/validation requirements.
- Carrying out all validation activities on equipment before handover/return to system owner and updating all relevant records and schedules
- Arranging specialist services to qualify specialist equipment
- Supervising technicians, fitters and contractors as required when external support is utilised for qualification activities
- Maintaining validation equipment in a state of calibration and compliance to support the company’s validation efforts
- You will also represent the business in customer audits and regulatory inspections to demonstrate that we have compliant systems.
- Develop and write quality discrepancies and investigations associated with the validation studies.
- Creating/maintaining qualification related records, procedures, documents and drawings
- Maintaining the validation schedule and keeping all equipment and processes in a qualified state to support Medical Device ISO 13485 requirements
- Work within the team to design, maintain, and continually improve the validation systems in line with current national and international standards.
- Ensure all validation is compiled and approved to meet regulatory requirements
- Some travel may be required for Factory Acceptance Testing.
- Any other tasks/duties deemed to be within the competence of the post-holder
- Continuous collaboration with global counterparts to ensure alignment of validation documentation and processes.
Other Job Requirements:
- Ensuring compliance with safety, health and environmental (SHE) legislation
- Be a leader in role modelling Thermo Fisher 4i values: Innovation, Integrity, Intensity, Involvement
- Work overtime when needed
Minimum Requirements:
- At least 3 years validation experience within a GMP environment
- Demonstrable validation experience in a medical device ISO13485, biopharmaceutical, microbiology, consumer healthcare or related industry
- Knowledge of commissioning and equipment validation to include autoclaves, temperature-controlled storage and automated production lines, cleaning validation experience, Software validation and transport validation.
- Proven problem-solving skills/diagnosing faults/resolving qualification issues
- Excellent planning and time management ability
- The ability to adapt to rapid changes in project priorities and meeting aggressive timelines
- The ability to work independently and autonomously to support validation projects and communicate progress and any issues via team meetings and project meetings.
- Demonstrated effective interpersonal skills with an ability to interface well at all levels.
- Good oral and written communication skills
- Be confident, pro-active, hardworking and looking to make a difference
- Good knowledge of typical office computer systems and software.
- Sense of urgency on work related matters
- A valid driving license.
Minimum Qualifications:
- 5 years’ hands on experience in a validation role
- Degree in a Biological Science, QA discipline or Engineering Degree
- GMP and ISO 13485 knowledge and understanding