A leading pharmaceutical manufacturer is seeking a Process Equipment Engineer to join its engineering and project teams, supporting capital and sustaining projects across Drug Substance, Vaccines, Bioprocessing and Parenteral manufacturing operations. The successful candidate will provide technical engineering expertise throughout the project lifecycle, ensuring equipment and process systems are specified, designed, installed, commissioned and maintained in compliance with GMP and regulatory requirements.
Key Responsibilities
- Provide engineering and technical support for manufacturing process equipment and systems across project and operational activities.
- Support capital projects through all lifecycle phases, including specification, design, installation, commissioning, qualification and validation.
- Implement equipment and system modifications through established change control processes.
- Maintain the validated state of process equipment and manufacturing systems.
- Participate in the development and maintenance of equipment lifecycle documentation.
- Support continuous improvement initiatives across manufacturing operations.
- Provide technical solutions to complex engineering and process challenges.
- Work closely with cross-functional teams to ensure projects are delivered safely, on schedule and in compliance with GMP requirements.
- Support equipment reliability, performance optimisation and operational excellence initiatives.
- Ensure adherence to all site safety standards and engineering procedures.
Requirements
- Bachelor's Degree in Chemical Engineering, Pharmaceutical Engineering, Biotechnology, Mechanical Engineering or a related discipline.
- 2-5 years' experience within a GMP-regulated pharmaceutical, biopharmaceutical or biotechnology environment.
- Strong technical engineering background with knowledge of manufacturing process equipment and systems.
- Experience supporting engineering projects or process equipment throughout the full lifecycle.
- Knowledge of GMP requirements, change control and validation principles.
- Ability to troubleshoot technical issues and provide effective engineering solutions.
- Strong communication, stakeholder management and teamwork skills.
- Experience working within cross-functional engineering and manufacturing teams.
Preferred Experience
- Capital project delivery experience within pharmaceutical manufacturing.
- Familiarity with Commissioning, Qualification and Validation (CQV) activities.
- Experience within a highly automated manufacturing environment, including PLCs, HMI, SCADA or DeltaV systems.
- Experience with process equipment such as:
- Process Vessels
- Chromatography Systems
- Ultrafiltration Systems
- CIP/SIP Systems
- Autoclaves
- Parts Washers
- Sterilisation and Decontamination Equipment
- Experience presenting qualification packages to internal and external auditors.
- Exposure to Drug Product, Drug Substance, Vaccines, API or Medical Device manufacturing environments.