The posting
Shape Manufacturing Processes from Development Through Commercialisation
Are you a Process or Manufacturing Engineer with experience in pharmaceutical, biotechnology, biopharmaceutical or other regulated production environments?
Join a multidisciplinary engineering team supporting the development, transfer, scale-up and optimisation of manufacturing processes. You’ll work across technical development, equipment implementation, process validation and continuous improvement, partnering with Manufacturing, Technical Services, Quality, R&D, Automation and Project teams.
This role offers broad technical exposure across new product introduction, technology transfer, manufacturing readiness, process improvement and engineering project execution.
Your Key Responsibilities
- Lead process and manufacturing engineering activities associated with capital projects, new product introductions, technology implementation and continuous improvement initiatives.
- Provide technical support throughout process development, technology transfer, scale-up, manufacturing implementation and commercial production.
- Plan and execute engineering trials, process studies, experiments and technical assessments for new or modified processes.
- Work with Technical Services and project stakeholders to define Critical Process Parameters (CPPs) and Key Process Parameters required for process and equipment validation.
- Act as a technical resource for assigned processes and manufacturing equipment, supporting troubleshooting, investigations, design reviews, change controls and future capital requirements.
- Develop process concepts, manufacturing schemes, feasibility assessments, Process Flow Diagrams (PFDs) and detailed technical project scopes.
- Identify opportunities to improve process robustness, safety, product quality, yield, productivity, operating costs and material utilisation.
- Support process and automation engineering deliverables, including control strategies, instrumentation specifications, alarm requirements and equipment shutdown or emergency philosophies.
- Draft, review and maintain technical procedures, master batch records and other manufacturing documentation in accordance with GMP requirements.
- Develop study plans, analyse process and engineering data, and prepare technical reports, development documents, study summaries and supporting memoranda.
- Assess new technologies and engineering solutions for potential implementation within existing commercial manufacturing processes.
- Coordinate scale-up and technology transfer activities from R&D or development environments into manufacturing, ensuring processes remain controlled and robust following implementation.
- Investigate manufacturing deviations and process-related problems using structured troubleshooting and root-cause analysis techniques.
- Recommend and track Corrective and Preventive Actions (CAPA) to address identified process or manufacturing issues.
- Participate in User Requirements Specifications (URS), equipment modifications, retrofit projects, Factory Acceptance Tests (FATs), Site Acceptance Tests (SATs) and equipment qualification activities.
- Contribute to Quality Risk Assessments (QRA) and process hazard reviews, identifying potential risks and supporting appropriate mitigation measures.
- Prepare project scopes, preliminary budgets and cost estimates to support CAPEX planning and engineering investment proposals.
- Manage several engineering assignments simultaneously while balancing technical priorities, project schedules and operational requirements.
- Collaborate with cross-functional teams and adapt effectively to changing manufacturing, project and business needs.
What We’re Looking For
- Degree or higher qualification in Biomedical Sciences, Life Sciences, Engineering or a related scientific/technical discipline.
- Approximately 2–5 years of relevant experience in Process Engineering, Manufacturing Engineering, Process Development or a related field.
- Experience in pharmaceutical, biotechnology, biopharmaceutical or other regulated manufacturing environments will be advantageous.
- Strong technical analysis, troubleshooting, investigation and problem-solving capabilities.
- Good interpersonal and collaboration skills, with the ability to work effectively across multidisciplinary teams.
- Strong written, verbal and presentation skills.
- Demonstrated ability to manage multiple assignments, establish priorities and deliver technical work within agreed timelines.
- Good understanding of manufacturing processes, process development, technology transfer, scale-up and technical operations.
- Proactive and accountable approach with strong attention to detail and a commitment to quality, compliance and continuous improvement.
Build Your Manufacturing Engineering Experience
This opportunity provides broad exposure to process development, technology transfer, scale-up, validation, manufacturing engineering and process optimisation within a regulated production environment.
You’ll work alongside technical and operational teams on a variety of engineering initiatives, gaining experience in both day-to-day manufacturing support and longer-term process and technology improvement projects.
If you’re looking to broaden your process engineering experience and contribute to robust, efficient and compliant manufacturing operations, we welcome your application.
Please send your updated resume to [email protected] with the subject “Pharmaceutical Process Engineer”.
Leon Leong De Cong R1551708 Recruit Express Pte Ltd EA License No. 99C4599
