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Process Validation Engineer

  1. Ireland, Cork
Cork
  1. Contract
Competitive
  1. Commissioning, Qualification and Validation
36640
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Process Validation Engineer, Drug Substance - Cork, Ireland - 12 Months Contract

Are you interested in joining a world leading biopharmaceutical company, focused on developing advanced and innovative treatments for those suffering with rare diseases?

This is a fantastic opportunity to work in a state-of-the-art facility in Cork. You will be joining a leading Biopharmaceutical company who focus on a range of products which are life-changing for individuals.

Our client is currently seeking Process Validation Engineer - Drug Substance

Responsibilities include:
  • Perform process validation activities related to Client’s drug substance and drug products, through defined clinical and commercial stages.
  • Execute (protocol generation, execution, and final package preparation) process validation activities related to the implementation of process changes and new processes while exercising supervised judgement within broadly defined procedures and practices to establish acceptance criteria, and to identify and implement solutions to meet Client’s and Health Authority requirements.
  • Assist with preparation of regulatory filings, with answering questions from regulatory agencies, and with presentations of materials during regulatory inspections/partner audits.
  • Development and implementation of SOPs/Guideline documents with systemic procedural improvements.
  • Determine methods and procedures on new assignments with supervision and in accordance with developed practices and procedures. 
  • May participate on sub-teams.
  • Gain/maintain knowledge of industry standards and regulatory requirements for products developed and manufactured by the Client, validation techniques/approaches and systems utilised by the Client.
Requirements:
  • Experience in a cGMP regulated manufacturing environment, with exhibited knowledge or proficiency in process validation, process sciences and change control.
  • Experience in a position utilising formal project management a plus.
  • Organisational and management skills to participate in multi-discipline project groups
  • Ability to communicate with, present data to, and defend approaches in front of variable hierarchical audiences, scientific disciplines and health authority reviewers/inspectorate.
  • Ability to comprehend scientific/technical information related to equipment, processes, and regulatory expectations.
  • Understanding and demonstrated knowledge of regulatory requirements, guidelines, and recommendations for process validation expectations. 
If this role is of interest, please apply now!

 #LI-JS5

 



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