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

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