Job Title: Senior Process Engineer - API Manufacturing
Overview
We are seeking a Senior Process Engineer to provide technical leadership in API manufacturing operations. The role will be responsible for process optimization, technology transfer, scale-up, process safety, cost reduction, and ensuring reliable and compliant production within a GMP environment.
Key Responsibilities
Process Engineering & Optimization
- Lead process design, scale-up, and optimization of synthetic chemistry and API production processes.
- Monitor, analyze, and improve key process parameters to maximize yield, productivity, and efficiency.
- Apply DOE, statistical analysis, and process modeling for troubleshooting and continuous improvement.
- Drive implementation of new technologies and automation to enhance reliability and reduce downtime.
Technology Transfer & Scale-Up
- Lead technology transfer from R&D or pilot plant to commercial manufacturing.
- Support scale-up activities including process mapping, risk assessments (HAZOP, FMEA), and design reviews.
- Ensure process knowledge and control strategy are handed over effectively to manufacturing operations.
Validation & Compliance
- Develop and execute process validation strategies, including BMR/BPR review, batch execution, cleaning validation, and equipment qualification.
- Ensure adherence to cGMP, ICH Q guidelines, and regulatory requirements for APIs.
- Maintain process documentation, SOPs, and change controls.
Process Safety & Risk Management
- Conduct and participate in process safety activities including HAZOP, safety reviews, and risk assessments.
- Support implementation of safety improvements for reactors, crystallization, filtration, and drying processes.
- Lead root cause analysis for deviations and support CAPA implementation.
Operational Technical Support
- Act as a technical SME for API operations such as:
- Chemical synthesis
- Crystallization
- Distillation
- Filtration and drying
- Solvent handling
- Provide real-time technical troubleshooting and continuous manufacturing support.
Cross-Functional & Project Leadership
- Work closely with Production, Quality, HSE, Supply Chain, and Engineering teams.
- Lead cross-functional projects including debottlenecking, yield improvement, and waste reduction initiatives.
- Support audits and regulatory agency inspections.
Qualifications
- Bachelor's or Master's degree in Chemical Engineering, Process Engineering, or related field.
- 4-6 years experience in API, pharmaceutical, chemical, or fine-chemical production environment.
- Hands-on experience with unit operations and equipment in chemical/API production.
- Strong knowledge of GMP, process validation, and regulatory expectations.
- Competent in statistical analysis tools (e.g., Minitab, JMP) and process modeling.
Preferred Skills
- Experience in continuous processing, automation, and PAT tools.
- Familiarity with ICH Q8/Q9/Q10 and QbD principles.
- Experience leading scale-up from lab/pilot to commercial scale.
- Lean Six Sigma certification is advantageous.
Soft Skills
- Strong analytical and problem-solving mindset.
- Able to communicate clearly with operators, scientists, and leadership.
- Leadership qualities with ability to influence and drive improvement.
- Proactive, hands-on, and results-oriented attitude.
