Senior Process Engineer - Sterile Polymer (Contract)
Overview
We are seeking an experienced pharmaceutical engineering professional to lead the development and implementation of a novel aseptic manufacturing process for biodegradable polymer-based implant products.
This role will take ownership of process design, equipment integration, supplier coordination, installation activities, and qualification support within an existing sterile manufacturing facility. The successful candidate will act as the technical authority for the project, ensuring the process can be successfully transferred into GMP operations while maintaining sterility assurance and operational efficiency.
The manufacturing process includes polymer gel preparation, extrusion, crosslinking, precision cutting, syringe assembly, and sterile packaging within an aseptic environment.
Responsibilities
- Develop and finalise the detailed manufacturing process design.
- Define equipment requirements and process flow for each manufacturing stage.
- Lead technical discussions with equipment vendors and technology suppliers.
- Evaluate and optimise polymer preparation, extrusion and crosslinking technologies.
- Design aseptic operations within Grade A environments using open RABS and laminar airflow protection.
- Support facility layout and equipment integration within constrained cleanroom space.
- Coordinate installation activities and supplier deliverables.
- Work directly with the customer as the primary engineering interface.
- Support GMP qualification activities including risk assessments, FAT, SAT, IQ, OQ and PQ.
- Collaborate with quality, validation, manufacturing and project teams to achieve operational readiness.
- Ensure compliance with pharmaceutical GMP and aseptic processing requirements.
Requirements
- Significant experience within pharmaceutical or medical device manufacturing engineering.
- Proven track record implementing new sterile manufacturing processes.
- Strong understanding of aseptic processing, cleanroom design and contamination control.
- Experience with polymer processing technologies including extrusion and crosslinking.
- Knowledge of sterile device or combination product manufacturing.
- Demonstrated experience managing equipment suppliers and technical project delivery.
- Familiarity with process qualification and GMP validation activities.
- Excellent stakeholder management and communication skills.
- Ability to operate as a technical lead across suppliers, customers and internal functions.
Experience with biodegradable polymers, implantable products, long-acting injectables, pre-filled syringes or advanced drug delivery technologies would be highly advantageous.
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