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Validation Engineer

Paisley, Renfrewshire
£35,000 to £45,000
Job Type
2 Sep 2022
The Role: In your role as Validation Engineer you are going to assist with the definition and implementation of operation validation activities that ensure effective oversight of the verification and validation activities are in compliance with EU/FDA regulatory requirements associated with an aseptic cleanroom process. You will also support process validations onsite and act as a subject matter expert in customer and regulatory audits. Role Responsibilities: • Support Software , Cleaning, Shipping , Room and Equipment qualifications in line with training and experience • Own and develop validation master validation plan and documentation onsite • Provide technical expertise and knowledge on validation to manufacturing group and beyond. • Drive continuous improvement throughout the site with respect to validation activities • Knowledge of current guidelines and regulatory requirements • Support during internal / external and third party audits Skillset & Experience: • BS Degree or higher in technical / scientific discipline • Excellent oral and written communication skills • Excellent knowledge of computer packages including ERP systems , Minitab , Microsoft project • Excellent Technical knowledge of process and equipment • Excellent knowledge of Validation processes ( IQ/OQ/PQ) and current regulatory requirements related to ISO13485/FDA CFR. • Experience working within a medical device manufacturing environment or cGMP manufacturing environment. • Good working knowledge of the Cell Culture and Bio production business or similar manufacturing process
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  • Job Reference: 702535042-2
  • Date Posted: 2 September 2022
  • Recruiter: Selexa Consulting Ltd
    Selexa Consulting Ltd
  • Location: Paisley, Renfrewshire
  • Salary: £35,000 to £45,000
  • Sector: Healthcare & Medical
  • Job Type: Permanent