We are seeking aSeniorProcess Engineerto support ongoing process developmentwithin aGMP‑regulated environment. This role will play a key partindefining and managing process requirements for pharmaceutical projects, supporting system design, technology transfer, risk assessments, and compliance activities to ensure successful project execution and operational readiness.
- Provide technical leadership in the development and implementation of process technologies across capital projects, operational improvements, and manufacturing support activities.
- Develop andmaintainprocess design requirements, ensuring they are clearly defined, measurable, and aligned with projectobjectivesand regulatory expectations.
- Review and interpret process data, technology transfer packages, and manufacturing requirements to support equipment and system design decisions.
- Partner with project, operations, quality, and engineering teams to ensure process solutions are effectively integrated into manufacturing environments.
- Lead technical evaluations and risk-based assessments toidentifyprocess improvement opportunities and mitigate operational risks.
- Support the design, commissioning, qualification, and validation of new and modified process systems to ensure they meet performance and compliance requirements.
- Provide subject matterexpertiseduring design reviews, troubleshooting activities, investigations, and processoptimisationinitiatives.
- Ensure process changes are appropriately assessed, documented, and implemented through established quality and change management systems.
- Facilitate risk assessments, FMEAs, and process hazard analyses to support project
- Ensure compliance with quality, validation, engineering, and regulatory standards.
- Partner with cross-functional teams to resolve technical issues and drive continuous improvement initiatives.
Requirements
- Proficient in authoring and executing DQ, FAT, SAT, IQ, OQ, PQ, and PV documents.
- Proficient in developing SOPs, finalreportsand validation & quality policies.
- Strong experience developing and executing CQV protocols.
- Strong experience creating and maintaining CQV policies and processes.
- Has good understanding and compliestocGMPsand CFR21 Part 11 guidelines.
- Exposure todigital and paper-based validation systems, including platforms such asKneat.
- Background inPre-filledsyringe (PFS) technology, Vial Filling, Sterile Filtration, Bulk Product, New Product Initiative (NPI) manufacturing, Plasma Manufacturing