Validation (Process) Engineer – 12-Month Contract
Overview
We are supporting a pharmaceutical manufacturing client with a significant process change and equipment upgrade project within a GMP-regulated environment. The project involves transitioning an existing powder handling and transfer process from six individual barrels per pallet to a one-ton bag (FIBC) system, mounted on a frame above processing tanks, supported by a new powder transfer system feeding the tanks as required.
A planned site shutdown at the start of July will be used to fully implement and commission the new system. During this critical phase, the Process Validation Engineer will be required to be fully on-site to support execution, issue resolution, and real-time validation activities.
Key Responsibilities
* Develop and author the Validation Master Plan (VMP) for the project.
* Lead validation strategy and execution for new powder handling and transfer equipment, including:
* One-ton bag (FIBC) handling and dispensing system
* Frame-mounted feed system above process tanks
* New powder transfer system
* Author, review, and execute validation documentation, including:
* User Requirement Specifications (URS)
* Risk assessments (e.g. FMEA)
* Installation Qualification (IQ)
* Operational Qualification (OQ)
* Performance Qualification (PQ)
* Support commissioning and shutdown execution activities, ensuring alignment between Engineering, Manufacturing, and Quality.
* Be fully on-site during the July shutdown to support:
* Equipment installation and changeover
* IQ/OQ execution
* Deviations and troubleshooting
* Rapid documentation updates where required
* Ensure validation activities are compliant with GMP, site quality systems, and regulatory expectations.
* Produce clear, inspection-ready documentation.
Required Experience & Qualifications
* Proven experience in process or equipment validation within a GMP-regulated pharmaceutical environment.
* Strong hands-on experience with IQ, OQ, PQ execution.
* Experience working on equipment upgrades, process changes, or shutdown activities.
* Solid understanding of EU GMP validation requirements.
* Comfortable working on-site during critical execution phases and independently managing validation deliverables.
Desirable Experience
* Experience with powder handling systems, FIBC / big bag systems, or powder transfer technologies.
* Prior experience supporting plant shutdowns or major changeovers.
* Experience authoring Validation Master Plans.
* Experience working cross-functionally with Engineering, Manufacturing, and Quality teams.
Important Notes for Contractors
Full on-site presence will be required during the July shutdown period to support system implementation and validation execution.
***This is a contract position only.
This role is an independent contractor position. Candidates must operate through their own limited company, invoice monthly, and be eligible to contract in Ireland. No employment benefits or statutory entitlements apply, and work is under a standard contractor agreement.