Process Engineer Role
The process engineer will provide project leadership and technical expertise for a new Fill/Finish facility with terminal sterilisation.
Client-side lead to work with equipment vendors to support the equipment lifecycle activities as part of a new facility start-up project.
Project management & subject matter expertise for a pharmaceutical fill / finish facility with terminal sterilisation operations.
Equipment lifecycle support from concept design, vendor selection, detailed design, build, CQV through to commercial operation.
In-depth knowledge of primary vendor equipment and technology including; a bulk drug product compounding suite supplying a filling system (vial/syringe/bags) with open RABS technology and terminal sterilisation.
In-depth knowledge of secondary vendor equipment and technology including; Parts washer, autoclave technology and clean utility services.
Responsible for developing and executing the equipment lifecycle activities. This will include writing URS documents, review / approval of Design Specifications, input into the control strategy, development and execution of the test matrix (leveraged) to support offsite / onsite execution (as per ASTM E2500).
Experience of working with equipment vendors through the key stages of the equipment lifecycle, including; procurement, design, build, FAT, install and SAT.
Knowledge of supporting a ‘best practise’ methodology to help deliver a science and risk-based approach to CQV for a green field project start-up.
The candidate should have strong leadership, direction and organisational planning skills to support the team through each stage of the project.
The role includes the need to develop and support the implementation of site procedures for robust and compliant GEP systems.
Self-motivated and passionate starter.
Team player who embraces collaboration for project success.
Ideally degree qualified; in Engineering, technical or science related field.
5+ years of progressive experience in project engineering role within a pharmaceutical (fill / finish) operation, including a thorough working knowledge of EU GMPs, FDA cGMP, GAMP 5, ICH guidelines, and GEP guidelines.
For further information, please contact Brenda Fitzgerald at firstname.lastname@example.org
Renew Health Ltd. Is an equal opportunities employer.