My client is a world leader in the pharmaceutical industry. They have a large manufacturing facility here and are going through a phase of expansion. They now seek an experienced process engineer for their API plant to serve as a recognised engineering specialist and a subject matter expert (SME) for API Processes and Equipment
- Assume responsibility for leading product manufacturing campaigns from the start of production and providing technical supervision with respect to quality and EHS until completion and release of the material
- Develop Manufacturing/Operating Instructions and necessary Standard Operating Procedures
- Develop, maintain and troubleshoot the process control system recipes and models
- Investigate, report and troubleshoot findings on both quality and EHS related issues observed during manufacturing or during batch record review.
- Develop, implement and monitor robust preventive measures for processing issues.
- Proactively monitor, identify, develop and implement improvements in processes and equipment.
- Resolve technical issues which arise with initiation and day to day execution of processes including change control, out of spec (OOS), non-conformances
- Identify, evaluate and implement process improvements which benefit cost, quality and cycle time.
- Investigate non-conformances (NCR) and develop corrective and preventive actions and generate and implement change controls
- Train process technicians on the process and procedures as required
- Conduct Validation (Installation Qualification (IQ), Operation Qualification (OQ), as well as Performance Qualification (PQ) when required) on new GMP equipment/system.
- Own one or more multiple equipment/GMP systems in production and present the system overview with evidence compliance to internal and external auditors
- Participate in HAZOP meetings to identify and mitigate potential risks prior to any start of campaign.
- Advanced Degree in Chemical Engineering, Chemistry or equivalent with at least 5 years' experience in a process engineering role with a pharma/chemical manufacturing plant
- Prior experience working in a GMP related facility will be a big plus
- Prior expertise in process engineering and troubleshooting for an API manufacturing processing equipment will be a big plus
- Equipment and Process Equipment knowledge to perform complex troubleshooting of equipment failures
- Must be a self-starter, curious with strong analytical and organizational skills
- Able to work under pressure and negotiate with internal customers
- Proven track record of resourcefulness and team management
- Proficiency with MS software and manufacturing systems (e.g. SAP)
Please send your resume in WORD format by clicking the apply button below or contact Abhik Damani on +65 6701 1527 for a confidential discussion. Please note that only short-listed candidates will be contacted. CEI Reg. Number R1544061 (Abhik Damani).