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Job ID :
40252BR
Location :
United Kingdom - Horsham
:
Job Description

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





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