Validation Engineer

Summary:
An amazing opportunity has arisen with our client a bio pharma company in Cork, for a Validation Engineer. The successful candidate will provide validation and technical support to the Vaccines Operations team.

Responsibilities:

• Execute and provide technical support for Building 8 upgrade project during the C&Q phase.
• Execute the validation of equipment, cleaning, utility systems, facilities, processes and/or automation systems for projects and post OQ activities.
• This includes adhering to validation strategies, coordinating with outside vendors, writing protocols independently, sample submission, analysing test results, and preparing technical reports.
• Part-take in cross-functional problem-solving teams for troubleshooting and investigations within Vaccines Operations.
• Technical report writing, statistical analysis of data.
• Support the completion of validation projects through adhering to validation schedules, master plans, validation protocols and reports for systems that may be complex in nature, to support clinical and commercial manufacturing.
• Adherence to the latest regulatory guidelines.
• Apply Lean Six Sigma and Lean methodologies to drive a culture of Continuous Improvement within the Operations.
• Represent the Operations on cross-functional project teams.
• Provide technical input and support and present as an SME on relevant topics during regulatory inspections.
• Assess and align Technical Operations priorities to the Operations and in turn site strategic map.
• Adherence to highest standards for Compliance (Quality and Safety).
• Ensure compliance with site EHS policy, cGMP and other business regulations and support Technical Operations 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.

Qualifications & Experience:

• B.Sc. Degree or other qualification in Biochemistry, Microbiology, Chemistry, Engineering or a related field.
• 3-5 years’ experience as a validation specialist in a pharmaceutical or a highly regulated environment.
• Experience in at least three of the following areas: C&Q validation, Cleaning Validation, Equipment validation, Process operations or manufacturing, 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.