Our client is a global manufacturing organization operating in highly regulated industries, with a strong focus on quality, safety, and operational excellence. The company supports international customers across pharmaceuticals, specialty chemicals, and performance materials.
 
With modern production facilities and robust quality systems aligned with cGMP and ISO standards, the organization emphasizes process engineering, continuous improvement, and sustainable manufacturing. Employees work in a collaborative, engineering-driven environment that encourages technical ownership, continuous learning, and cross-functional teamwork.
 
Job Purpose
The Senior Production Engineer is responsible for optimizing manufacturing process flows to improve yield, productivity, and product quality. The role leads process analysis, equipment and process qualification, and continuous improvement initiatives while ensuring full compliance with cGMP and ISO9001 standards.
 
Key Responsibilities
 
Manufacturing Process Expertise:

• Analyze and optimize production processes to identify and eliminate bottlenecks.
• Monitor process performance and recommend improvements impacting quality, safety, and efficiency.
• Use process simulation and data analysis tools to support optimal production strategies.
• Conduct risk assessments (FMEA, HACCP, ICH Q9) to ensure regulatory compliance.
• Prepare and maintain technical documentation in accordance with cGMP and ISO9001 requirements.
• Present process qualification and validation results during audits and inspections.

Continuous Improvement & Qualification:

• Ensure equipment, utilities, and facilities consistently meet quality and regulatory requirements.
• Manage lifecycle qualification and validation documentation for production equipment.
• Propose and support continuous improvement and technology upgrade initiatives.
• Troubleshoot production issues in collaboration with manufacturing and maintenance teams.
• Lead, organize, and train teams on qualification and validation activities.

Quality, Safety & Environment:

• Actively support and comply with company Quality, Safety, Health, and Environmental (QHSE) policies and procedures.

 
Requirements and Qualifications

• Bachelor’s or Master’s degree in Chemical Engineering (preferred), or
• Industrial Engineering with strong knowledge of chemical processes is a MUST
• Minimum 7 years of experience in process or production engineering
• Background in GMP and/or ISO9001 manufacturing environments
• Strong knowledge of production equipment, chemical processes, and manufacturing standards
• Hands-on experience in:
• Equipment qualification (DQ/IQ/OQ/PQ)
• Process validation and technology transfer
• Process monitoring, data trending, and statistical analysis
• Strong analytical, problem-solving, and continuous improvement mindset
• Excellent documentation, communication, and presentation skills
• High attention to detail and strong troubleshooting capability
• Proficient in MS Office, MS Project, Minitab, AutoCAD, and DCS
• Good command of English (spoken and written)