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Clean & Process Validation Specialist

Expired
  • Salary: Negotiable
  • Job type: Contract
  • Location: Cashel, Tipperary
  • Sector: Science
  • Date posted: 03/08/2018
  • Job reference: BBBH15254

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Validation Specialist
Summary
A Clean & Process Validation Specialist is required to join a leading pharmaceutical company. This position offers an impressive and unique opportunity for interested candidates. This position requires people who want to be challenged, have a passion for success, and a constant drive to exceed expectations.

This role will be responsible for ensuring the qualification and validation of equipment, facilities, utilities, computerised systems, processes and process cleaning procedures are carried out in accordance with company procedures and policies, cGMP and relevant guidelines. This is a perfect opportunity to join a select team that has already established itself as a frontrunner leading the way in the Pharmaceutical industry.

Responsibilities

  • Preparation and review of SOPs related to Cleaning and Process Validation; Responsible for preparation, execution and coordination of Cleaning Development / Verification / Validation and Process Validation study protocols and reports
  • Overview of swab sampling (bioburden and chemical) as well as preparation and review of cleaning plans and closure reports Responsible for preparation of Cleaning / Process Validation protocols and reports for post approval
  • Responsible for generation of Project Plans, preparation and review of any other documents related to cleaning and process validation
  • Responsible for preparation of Equipment/Product Matrices to define MACO limits for new products
  • Preparation, review and approval of validation master plans and validation plans
  • Preparation, review and approval of qualification and/or validation documentation (specifications, protocols, reports etc.) in relation to instrument, equipment, facilities, utilities, manufacturing and laboratory based computerised systems, manufacturing processes and cleaning processes.
  • Preparation, review and approval of standard operating procedures and policies.
  • Perform periodic reviews of systems in order to maintain validation status.
  • Comply with all Ipsen procedures including safety procedures.



Education/Experience

  • Bachelor's Degree (BA/BS) BS: in Pharmaceutical manufacturing, Engineering, Science or relevant field Master Degree (MS/MA) (MS/MA): Pharmaceutical manufacturing, Engineering, Science or relevant field
  • 3-5 years-experience in engineering, pharmaceutical industry, cGMP environment preferably in a manufacturing/quality capacity
  • Develop as SME in Cleaning 7 Process Validation High level of ownership and accountability
  • Understanding of cleaning or process validation requirements in a GMP environment



Interested?

  • Do not hesitate to reach out to Jack on 01-6455250 or email your CV to jack.conway-kenny AT experis.ie
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