Validation Engineer

Role Purpose:

• An amazing opportunity has arisen for a Cleaning Validation Engineer – Vaccines IPT to join our client’s busy pharmaceutical site based in Co. Cork.
• The successful candidate will provide validation (primarily cleaning cycle development and cleaning validation) and technical support to the Vaccines IPT team.
• The role will be reporting to the Vaccines IPT Associate Director.

Core Duties and Responsibilities:

• Execute cleaning cycle development, cleaning validation and PQ of equipment.
• 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, change control, risk assessments.
• Provide support during commissioning phase by reviewing and approving documents. Ensure documentation complies with standards.
• 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 the Manufacturing Division Quality Management System (QMS) requirements, including ownership, as relevant.

Education & Qualifications Required:

• Sc. Degree or other qualification in Chemical Engineering, Biochemistry, Microbiology, Chemistry 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.

Please note, we do not require agency assistance with this role.