Validation Engineer

ref. 01197

Validation Engineer

Join a dynamic team and collaborate with our client, one of the world’s top Biopharma corporations as a Validation Engineer in this exciting contract role.

The successful candidate will provide validation (primarily cleaning cycle development and cleaning validation) and technical support. This role involves provide project validation support, conducting equipment performance qualifications, specifically cleaning and sterilization validation. Authoring project validation master plans; SOP and documentation updates; validation protocols and final reports. Executing validation studies, analysis of validation data; Troubleshooting technical issues encountered during study execution.

Responsibilities
• Perform 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.
• Part-take in cross-functional problem-solving teams for troubleshooting and investigations
• Provide technical input and support and present as an SME on relevant topics during regulatory inspections.
• Execute run the business activities e.g. equipment periodic reviews, cleaning periodic review, CAPAs and deviations, change control, risk assessments.
• Support during commissioning phase by reviewing and approving documents. Ensure documentation complies with standards.
• Guarantee 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 supporting and complying with the Manufacturing Division Quality Management System (QMS) requirements, including ownership, as needed.

Requirements
• Minimum of 3-5 years’ experience as a Validation specialist in a pharmaceutical or a highly regulated environment.
• B.Sc. Degree or other qualification in Chemical Engineering, Biochemistry, Microbiology, Chemistry or related.
• Experience across 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.