Associate Process Engineer, Technical Operations - Small Molecule Drug Substance

About the role

We are seeking an Assoc. Process Engineer, Technical Operations – Drug Substance to join our dynamic team. This role offers an opportunity to contribute to the development and manufacture of active pharmaceutical ingredients (APIs) in a forward-thinking, research-intensive biopharmaceutical setting.

Responsibilities

• Support the Capital Project Team, contributing to design, commissioning, qualification, and startup readiness
• Take ownership of assigned process equipment and manufacturing processes
• Support technology transfer, and validation activities (e.g. pre-PPQ, PPQ)
• Analyse process data to support performance monitoring, troubleshooting, and improvement
• Provide on-the-floor technical support during manufacturing campaigns
• Execute technology transfers for new products and processes into the facility
• Contribute to process fit assessments, scale-up readiness, and manufacturability evaluations
• Support development and review of batch documentation and process instructions
• Aid in integration of new technologies into manufacturing operations
• Identify and implement improvements in process robustness, product quality, and plant performance
• Contribute to cleaning and turnaround optimisation activities
• Assist in deviation investigations, root cause analysis, and implementation of CAPAs
• Maintain process performance, yields, and cycle times to identify improvement opportunities
• Ensure all activities are conducted in compliance with cGMP, safety, and environmental standards
• Support campaign preparation, execution, and post-campaign review activities
• Aid in regulatory and inspection readiness activities
• Ensure accurate documentation of process knowledge, investigations, and improvements
• Work closely with Manufacturing, Quality, Engineering, Supply Chain, and R&D teams
• Provide technical input into projects, process changes, and ongoing operations

Qualifications

• Bachelor's Degree in Chemical or Process Engineering or related discipline
• Typically 1–4+ years’ experience in API manufacturing, process development, or related pharmaceutical environment
• Exposure to API processing operations and scale-up
• Understanding of cGMP manufacturing and regulatory expectations
• Experience in one or more of: Process support or development, Technology transfer, Manufacturing operations

Skills

• Strong analytical and problem-solving capability
• Effective communication and collaboration across cross-functional teams
• Proactive, self-driven approach to continuous improvement