Validation Engineer

DEP ON EXP
Newcastle under Lyme

KDL6XWX535
Permanent

Karen Dennis
01270 629090 ext 301

Working within the Quality Team, the Validation Engineer is accountable for the validation for Processes, Facilities, Equipment, Cleaning, Computer Software Validations and IT Projects within a medical device and pharmaceutical (cGMP) environment.

 

Key duties will include:

  • Prepare and issue Site Validation Master Plans (SVMP), Summary Reports and other documents for a validation exercise
  • Organise and lead validation activities
  • Plan validation activities, ensuring customer and business needs are met
  • Provide validation leadership, ensuring all operations are carried out in compliance with regulatory and company requirements.
  • Provide specialist knowledge on validations
  • Promote effective working relationships ensuring they are maintained through the validation working party
  • Support a continuous improvement culture within the business
  • Provide leadership, guidance and direction to staff consistent with ISO13485, 21 CFR 820 and relevant pharmaceutical requirements
  • Develop work plans, assign tasks and supervise teams to achieve validation requirements
  • Ensure staff have knowledge and training require to carry out validation activities
  • Maintain site validation status according to regulatory requirements
  • Identify resource requirements and rate limiting steps within the SVMP

 

Key skills and experience required:

  • Degree (or equivalent) within a science discipline preferred
  • Previous Validation experience within medical devices or pharmaceutical is essential
  • Proficient in Minitab or alternative software package is essential
  • Excellent communication and people management skills
  • Ability to work to deadlines, taking initiative within a controlled working environment
  • Strong attention to detail
  • Knowledge of Quality Management Systems would be beneficial
  • Experience of manufacturing process validation would be an advantage
  • ILM Level 5 would be beneficial

 

Hours of work: Monday – Friday, 35 hours between 7.45am and 5.15pm

Holidays: 25 days + bank holidays

 

Own transport required as you may be required to travel between sites

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