AMC0007
Validation Engineer
12 months
On site - South Dublin

An exciting opportunity has opened in the validation team of a leading biopharmaceutical manufactuer based in South Dublin.

In this role, you will be responsible for delivering on the qualification and validation program, which will include planning and execution of sterilisation validation / requalification activities on critical sterilisation/decontamination equipment. The sterilisation team perform /validation/ re-qualification on equipment such as VHP isolators, autoclaves, CIP/SIP systems and Lyophilisers and provide validation oversight on aseptic processing simulations.

This role will focus on HVAC requalification in the production environments, including managing the routine re-qualification program of airflow visualisation and filter integrity testing activities as well as testing in response to changes to the production environment.

If you have 3+ years experience in Validation in pharma/biopharmaceutical manufacturing with experience in HVAC this could be the role for you!

Responsibilities

• Provide technical validation support to meet site objectives, comprising of the full validation lifecycle process.
• Develop, review and approve validation plans, protocols, discrepancies summary reports in the area of sterilization validation.
• Provide support for the aseptic process simulation program, including aseptic intervention review, protocol generation, execution and summary report generation.
• Provide support for airflow visualisation studies and HVAC requalification program.
• Provide support for the execution of cycle development, performance qualifications and requalification program in line with projects and site validation masterplans.
• Collate and report on relevant validation data and metrics.
• Assist in the development and improvements of the validation lifecycle process while ensuring continued compliance to all applicable regulations and company standards. In addition, provide input and guidance into multisite and local procedural requirements.
• Provide validation support for company quality management system, including change control, deviation and CAPA processes.
• Coordinate projects and prioritize workload in line with site priorities.
• Participate, when required, as a member of multidisciplinary site and multisite teams, e.g. cross functional investigation teams and change control
• Update and maintain validation Standard Operating Procedures (SOPs) in accordance with site and corporate requirements.
• Participate in regulatory inspections, regulatory filings
• Attend and contribute to staff meetings and attend appropriate training sessions, as required.
• Comply with the responsibilities as outlined in the Site Safety Statement and champion safe working practices and initiatives within their functional area.
• Perform all tasks with due care and attention and in accordance with Good Manufacturing Practices and requirements, policies and procedures.

• Bachelor of Science/Engineering degree or equivalent.
• 3+ years’ experience in a similar role in a GMP environment

• Experience in equipment qualification and the validation lifecycle process in line with ASTM E2500.
• Experience qualifying sterilisation equipment, isolators, HVAC systems and/or providing validation support for aseptic process simulation.
• Experience of Quality and Document Management Systems including Trackwise Deviations, CAPA and Change Controls, Maximo, CDOCs, Kneat.
• Independent, self-motivated, proactive, organized, able to multi-task in project environments and skilled in communication and collaboration.
• Team player, prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making.