Senior Compliance and Validation Egineer

Thermo Fisher Scientific
07 Oct 2016
20 Oct 2016
Contract Type
Job Title: Senior Compliance and Validation Engineer Reports To: Facilities and Engineering Director Group/Division: BioPharma Services Career Band: 8 Job Track: Management Position Location: Horsham, UK Number of Direct Reports: 2 Position Summary: To Manage and drive validation/qualification and change control activities for FCS Horsham Engineering and Facilities Department Manage all aspects of quality within the Facilities and Engineering Department Own and drive the Good engineering Practice management system Key Responsibilities: To drive and own validation and qualification activities including equipment, facilities, systems, The preparation, review and issuing of Validation protocols Devise the relevant qualification and validation plan, URS, DQ,IQ,OQ,PQ , FAT,SAT, Traceability Matrix, and summary reports Reviewing and approving the relevant documents on validation processes and quality attributes of the department Ensure that the Validation / Qualification and quality systems are working in accordance with any changing and current regulations. To support change control activities, deviations and SOP's within equipment and facilities, To coordinate validation/qualification and change control activities With direct reports, be responsible and accountable for all equipment and facilities qualification plans and Good Engineering Practices Manage the quality aspects within all internal facilities and engineering projects Minimum Requirements/Qualifications: (Bullets) Bachelor's Degree in Quality Assurance, Electrical Engineering, Mechanical Engineering, Biomedical Engineering, or degree in biological science, or extensive career history within this or equivalent role Strong technical proficiency of Quality Management Systems with focus on Engineering qualification / validation functions Non-Negotiable Hiring Criteria: (Bullet 3-5 key quantifiable skills or position requirements that the candidate must have to be considered for this position.) Ability to work within a team providing support to other members Ability to work without direct supervision, on own initiative within the remit of the role The successful Senior Validation Engineer will need to demonstrate management in validation and qualification within a Pharmaceutical or GMP environment This role will require excellent communication skills High degree of accuracy, concentration, verbal and written communication