Engineering Manager, Pharma/API Manufacturing Leader

Symbiotica Speciality Ingredients; Kulim; On-site; MYR 100,000 - 130,000; Full time

Job summary

A leading pharmaceutical company in Kulim, Kedah is seeking an experienced Engineering Manager to lead engineering activities at their API manufacturing site. The successful candidate will ensure compliance with safety and quality standards while managing capital projects and engineering functions. The ideal candidate has a Bachelor's in Mechanical Engineering and 10-12 years of relevant experience, including handling regulatory inspections. This role emphasizes leadership, problem-solving, and continuous improvement in manufacturing processes.

Qualifications

• 10–12 years of experience in Pharma/API manufacturing or regulated chemical plants.
• Experience handling regulatory inspections and audits is essential.

Responsibilities

• Lead site engineering functions including engineering, maintenance, utilities, and projects.
• Ensure high equipment availability and plant reliability in compliance with cGMP requirements.
• Manage capital projects including new facilities, equipment installation, and plant upgrades.
• Support technology transfer, scale-up, and commercialization of new API processes.
• Collaborate with Quality Assurance during audits and regulatory inspections.

Skills

Leadership skills

Problem-solving

Cross-functional collaboration

Continuous improvement

Education

Bachelor’s degree in mechanical engineering

Job description

A leading pharmaceutical company in Kulim, Kedah is seeking an experienced Engineering Manager to lead engineering activities at their API manufacturing site. The successful candidate will ensure compliance with safety and quality standards while managing capital projects and engineering functions. The ideal candidate has a Bachelor's in Mechanical Engineering and 10-12 years of relevant experience, including handling regulatory inspections. This role emphasizes leadership, problem-solving, and continuous improvement in manufacturing processes.