Process Engineer
4 weeks ago
About the Role
We are seeking a highly experienced Senior Process Engineer to join a leading pharmaceutical manufacturing facility. This role will focus on supporting API (Active Pharmaceutical Ingredient) manufacturing through process engineering, tech transfer, and commissioning and qualification of process equipment. The successful candidate will play a key role in ensuring operational efficiency, regulatory compliance, and successful implementation of new processes.
Key Responsibilities- Lead and execute process engineering activities to support API manufacturing, including troubleshooting, optimisation, and scale-up.
- Manage and support technology transfer of new products and processes into manufacturing.
- Plan, develop, and execute commissioning and qualification (C&Q) activities for process equipment and systems.
- Ensure compliance with GMP standards and regulatory requirements in all process engineering activities.
- Provide technical support to production and maintenance teams to resolve process-related issues.
- Analyse process data to identify opportunities for continuous improvement and increased efficiency.
- Develop and maintain process documentation, including SOPs and validation protocols.
- Collaborate with cross-functional teams, including QA, Manufacturing, and Engineering, to ensure seamless integration of new processes and equipment.
- Bachelor's or Master's degree in Chemical Engineering or a related field.
- 5+ years of experience in process engineering within pharmaceutical manufacturing, with a focus on API production.
- Proven experience in technology transfer and commissioning and qualification (C&Q) of process equipment.
- Strong knowledge of GMP regulations and industry standards.
- Excellent problem-solving skills and ability to work with cross-functional teams.
- Strong analytical and project management skills.
Management Skills
Troubleshooting
Regulatory Compliance
HAZOP
Technology Transfer
GMP
Process Engineering
Compliance
Project Management
Regulatory Requirements
API
Process Control
Manufacturing
Chemical Engineering
Commissioning
Technical Support
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