Validation Engineer - Medical Device - London - £60 per hour

Recruiter
Optimus Search Limited
Location
London, UK
Salary
Competitive
Posted
21 May 2019
Closes
23 May 2019
Ref
1157632180
Sector
Engineering
Contract Type
Permanent
Hours
Full Time
Validation Engineer
Location: London, England, United Kingdom
Job Type: 9 Month Contract
Rate: £60 per hour
Start Date: ASAP

I am currently recruiting for an exciting opportunity within a Medical Device company based in Sligo. This is an excellent opening for anyone who is looking to join an awarding Medical Device company.

The primary purpose of this job is to support major Manufacturing Engineering Projects. The position is part of a team within the Engineering department that contributes to the overall business metrics. This position will provide project leadership on continuous improvement, and risk mitigation initiatives and will also include liaison with outside suppliers and other sites to ensure all goals and targets of the manufacturing process are achieved.

Duties
  • Competent in validation requirements on new processes, equipment introductions & process changes
  • Responsible for performing process validation studies by following approved standard operating procedures (SOPs), current Good Manufacturing Practices (GMPs) and all other regulatory requirements
  • Process Validation for process creation
  • Process Validation for the transfer of processes within the facility
  • Defines the requirements for Process Validation studies in alignment with approved SOPs
  • Executes test plans according to approved procedures, performs sampling, tabulates test results, and organizes data packages
  • Compiles and analyses validation data, prepares reports and makes recommendations for changes and/or improvements
  • May also investigate and trouble-shoot problems which occur, and determine solutions
  • Coordinates and executes validation change control and preparation of draft protocols, reports and data tables
  • Maintains and archives all documentation pertaining to validation
  • Participates on cross-functional project teams with the support of Development, Manufacturing, Engineering, Quality, and other groups
  • As required, prepares summaries of validation testing for regulatory submissions, and presents validations to regulatory agencies
  • Independently applies validation principles to work assignments, reviews and approves documents and resolves problems
  • Coordinates assigned projects and represents department on project teams
  • Resolves validation issues of moderate scope with limited direct supervision

Requirements:
  • Previous experience in the Medical Device, Pharmaceutical or Biotechnology industry
  • Bachelor's degree (or equivalent) in a relevant Engineering or Science discipline (Manufacturing, Mechanical, Electronic, Production etc...)
  • Working knowledge ISO 9001/2000 and/or ISO 13485
  • Fluent in English (written and spoken)
  • Investigation and report writing skills
  • Proficient in Microsoft Office applications
  • Experience in Statistical analysis
  • Experience in regulated industry, FDA, ISO, etc.
  • Demonstrated leadership skills and the ability to make effective decisions

If you are interested in this position then apply now, or contact me directly via telephone or email:

Cameron Huntington
Specialist Recruiter - Pharmaceuiticals and Medical Devices (UK and Ireland)
Optimus Life Sciences
+44 (0) 203 439 2247

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