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Job Description
Validation Engineer required for a leading multi-national Biologics client in Cork, Ireland. The role involves providing validation and technical support to the Vaccines IPT team.
Summary: Experienced Validation Engineer needed for a 11-month contract position to provide validation and technical support to the Vaccines IPT team.
Job Description:
- Provide validation (primarily cleaning cycle development and cleaning validation) and technical support to the Vaccines IPT team.
- Execute cleaning cycle development, cleaning validation and PQ of equipment.
- Write and adhere to validation strategies, coordinate with outside vendors, write protocols independently, sample submission, analyze test results, and prepare 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.
- Participate in cross-functional problem-solving teams for troubleshooting and investigations within Vaccines IPT.
- Write technical reports, perform statistical analysis of data, and adhere 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.
- Ensure compliance with site EHS policy, cGMP, and other business regulations.
- 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.
Requirements:
- 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 a related field.
- 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, including GLIMS and eVAL, electronic batch records.