An exciting 12-month contract opportunity (x2 roles available) for experienced Process Development Engineers to support the development and implementation of drug product formulation and filling processes, with a focus on syringe filling and single-use technologies. The role involves working on large-scale expansion projects and supporting both small and large molecule manufacturing operations. The position requires close collaboration with cross-functional teams, a strong background in aseptic processing, and expertise in qualification and validation of formulation and filling systems.
Responsibilities
- Support the development and characterisation of single-use systems and filling technologies.
- Lead the creation and verification of qualification protocols for single-use systems.
- Support formulation and filling process development, including protocol creation, execution, and reporting.
- Lead cross-functional teams to drive complex projects to completion.
- Perform risk assessments and implement CAPAs for drug product operations.
- Provide technical support for drug product manufacturing and technology transfer activities.
- Investigate and troubleshoot equipment or processing issues using data-driven approaches.
- Participate in deviation resolution and root cause investigations.
- Collaborate with site teams, engineering, and vendors on new equipment impacting validated processes.
- Contribute to validation protocols, quality documentation, and product quality assessments.
- Ensure compliance with regulatory requirements and internal quality standards.
Qualifications
- Bachelor's degree in Science, Engineering, or related discipline with 5+ years of relevant experience, or
- Master's degree with 3+ years of relevant experience, or
- Associate's degree with 10+ years of relevant experience.
- In-depth knowledge of cGMP and aseptic manufacturing practices.
- Strong communication and technical writing skills.
- Experience in developing formulation and filling systems using engineering and scientific principles.
Preferred:
- 10+ years of experience in commercial drug product processing, including sterile processing, tech transfer, and validation.
- Background in protein drug product formulation and filling technologies.
- Experience with peristaltic and time-pressure filling systems.
- Familiarity with protein stability and biochemistry.
- Strong understanding of quality systems and regulatory compliance.