Validation Specialist

• Execute 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 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 Vaccine manufacturing.
• Technical report writing, statistical analysis of data.
• Adherence to the latest regulatory guidelines.
• Represent Operations 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 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.

• 3-5 years' experience as a validation specialist in a pharmaceutical or a highly regulated environment and a B.Sc. Degree or other qualification in Chemical Engineering, Biochemistry, Microbiology, Chemistry or a related field.
• Experience in at least three of the following 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.

Tandem Project Management