Validation Engineer – Vaccines IPT – Co. Cork
Role Summary:
- An amazing opportunity has arisen for a contract Validation Engineer – Vaccines IPT at our clients Co. Cork facility.
- The successful candidate will provide 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 and provide technical support for a building upgrade project during the C&Q phase.
- Execute the validation of equipment, cleaning, utility systems, facilities, processes and/or automation systems for projects and post OQ activities. 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, statistical analysis of data
- Support the completion of validation projects through 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 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.
Minimum Qualifications and Experience:
- B.Sc. Degree or other qualification in Biochemistry, Microbiology, Chemistry, Engineering or a related field.
- Minimum 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.
To Apply: Quote – PE23060
If you would like to discuss this vacancy or to discuss your career and other job opportunities in confidence, contact us:
GC North Valley Business Centre, Cork, T23 KC67, Ireland.
+353 21 2066178
recruitment@prochem.ie
Please note, we do not require agency assistance with this role.
