Engineering Manager - Pharma/API Manufacturing

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

Engineering Manager - Pharma/API Manufacturing

Symbiotica Speciality Ingredients – Kulim, Kedah

Role Summary

The Engineering Manager is responsible for leading engineering activities at the API manufacturing site, ensuring reliable, compliant, and cost-effective operations. The role supports GMP manufacturing through robust engineering, maintenance excellence, capital project execution, and continuous improvement while meeting regulatory, safety, and quality standards.

Key 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 from concept to commissioning and validation
• Support technology transfer, scale‑up, and commercialization of new API processes in collaboration with Production
• Ensure engineering change management (ECM), qualification, and validation activities (DQ, IQ, OQ, PQ)
• Oversee utilities (PW, WFI, HVAC, compressed air, nitrogen, steam) and ensure regulatory compliance
• Ensure adherence to EHS standards and statutory regulations
• Collaborate with Quality Assurance during audits and regulatory inspections (USFDA, EMA, WHO, etc.)
• Manage engineering budgets, contractors, vendors, and service providers
• Develop and implement SOPs, engineering standards, and best practices
• Build, mentor, and develop high-performing engineering teams
• Strong understanding of cGMP, regulatory expectations
• Expertise in API manufacturing / Chemical Manufacturing plant engineering
• Proven experience in capital project management and validation
• Knowledge of utilities, automation, and maintenance management systems
• Experience with continuous improvement skill
• Strong leadership, problem-solving, and cross‑functional collaboration skills

Qualifications & Experience

• Bachelor’s degree in mechanical engineering
• 10–12 years of experience in Pharma / API manufacturing or regulated chemical plants
• Experience handling regulatory inspections and audits is essential