17746-Validation Engineer II-Cork Contractor

This role is an 11 month contract with a view to extension.

Purpose

An amazing opportunity has arisen for a Validation Engineer – Vaccines IPT. The Validation Engineer will provide validation and technical support to the Vaccines IPT team and the role will be reporting to the Vaccines IPT Associate Director.

Responsibilities

• Execute and provide support for transforming the business activities within the Vaccine IPT.

• Execute the validation of equipment, cleaning, utility systems, facilities, processes, and/or automation systems for projects. 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 IPT.

• Technical report writing, and statistical analysis of data.

• Support the completion of validation projects by 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 IPT.

• Represent the IPT 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 IPT priorities to the IPT and in turn site strategic map.

• Adherence to the 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

• 3-5 years of experience as a validation/qualification specialist in a pharmaceutical or highly regulated environment and a B.Sc. Degree or other qualification in Biochemistry, Microbiology, Chemistry, Engineering, or a related field.

• Experience in at least three of the following areas: Cleaning Validation, Process and Equipment validation, Process operations or manufacturing, Process Engineering, and Technology transfer.

• 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.