• Join a Large and established Validation team working on both Sustaining and CAPEX projects
• Excellent opportunity to Broaden and Building Validation Experience
• Strong Hourly Rate

Elusav Recruitment is currently recruiting a Validation Engineer to join a multinational pharmaceutical company. This is a full-time position on a contract basis based in Brinny.

As a Validation Engineer, you will support several aspects of Validation such as Sterilisation, Cleaning, Isolator, CTU & Filter Validation. This is a great opportunity to join an industry leader that offers a great structure in CAPEX projects.

Responsibilities:
• Review of IOQ documentation for Utilities and Equipment e.g. Autoclave, Lyos, COP/SOP during C&Q phase. Ensure documentation complies with standards.
• Execute cycle development and PQ of utility systems and equipment, cleaning validation, facilities for post OQ activities. This includes writing and adhering to validation strategies, coordinating with outside... vendors, writing protocols independently, sample submission, analysing test results, and preparing technical reports.
• Execute run the business activities e.g. equipment periodic reviews, cleaning periodic review, CAPAs and deviations
• Part-take in cross-functional problem-solving teams for troubleshooting and investigations within Vaccines IPT
• Technical report writing, statistical analysis of data
• Adherence to the latest regulatory guidelines.
• Represent the IPT on cross-functional project teams.
• Provide technical input and support and present as an SME on relevant topics during regulatory inspections.
• Adherence to highest standards for Compliance (Quality and Safety)
• Ensure compliance with site EHS policy, cGMP and other business regulations and support Technical IPT input to risk assessments, audits, regulatory inspections and incident investigations.
• Ensure the highest Quality, Compliance and Safety standards by participating and complying with our Manufacturing Division Quality Management System (QMS) requirements, including ownership, as relevant.

Requirements:
• Relevant technical qualification(s) in Applied Pharmaceutical / Biological / Chemical sciences or applied Technical / Engineering qualification
• Experience in at least three of the following areas: C&Q validation, Cleaning Validation, Equipment validation, Process operations or manufacturing, and Process Engineering.
• A working knowledge of the GxP systems associated with this role would be advantageous. These include, but are not limited to: GLIMS and eVAL, electronic batch records.

Phone contact:

If you would like to learn more about the vacancy, apply now, or contact Stephanie Santana on [email protected] or +353 (069) 599 93
Cork Ireland

Salary Criteria