We are seeking a Senior Process Engineer with proven expertise in small molecule Active Pharmaceutical Ingredient (API) manufacturing. This hands-on role will be responsible for driving process improvements, supporting operations on a rotating shift basis, ensuring safe and efficient plant performance, and mentoring operations and engineering staff. The ideal candidate is an experienced leader with the technical acumen and operational flexibility to thrive in a dynamic, 24/7 manufacturing environment.
Key Responsibilities:
- Provide daily process engineering support for small molecule API manufacturing operations during assigned shifts.
- Serve as a subject matter expert (SME) for process troubleshooting, deviation investigation, and root cause analysis.
- Monitor, analyse, and optimize process parameters to ensure safety, compliance, quality, and efficiency targets are consistently met.
- Lead and support commissioning, qualification, and validation activities for new or modified equipment and processes.
- Initiate and implement continuous improvement projects to maximize throughput, yield, and operational reliability.
- Develop and update process documents, SOPs, batch records, and risk assessments.
- Mentor and train operations personnel on process equipment, changes, and troubleshooting methodologies.
- Act as a key interface between Production, Quality, Maintenance, and Engineering teams during shift hours.
- Participate in and support safety programs such as hazard reviews, HAZOPs, and incident reporting.
- Support regulatory inspections and audits as required.
Qualifications & Experience:
- Bachelor’s or Master’s degree in Chemical Engineering, Process Engineering, or related field.
- Minimum 5 years of experience in Small Molecule API manufacturing in a GMP-compliant environment.
- Deep understanding of GMP, EHS, and regulatory requirements for pharmaceutical manufacturing.
- Demonstrated success working in a fast-paced, shift-based operations environment.
- Significant experience in troubleshooting, process optimisation, and deviation management within chemical or pharmaceutical manufacturing.
- Excellent interpersonal and communication skills.
- Ability to work independently and make effective decisions during off-hours and emergencies.