全职 Engineering Manager – Pharma - API Manufacturing 工作, 薪水, Symbiotica Speciality Ingredients 公司招聘中 - Ricebowl

Company Description

Symbiotica Speciality Ingredients Sdn Bhd is a leading provider of complex steroidal Active Pharmaceutical Ingredients (APIs). The company is driven by its vision to advance health and well-being globally by delivering high-quality APIs. Known for its innovation and commitment to excellence, Symbiotica is respected as a key player in the field. Headquartered in Penang, Malaysia, the company is dedicated to improving lives through its impactful contributions to the pharmaceutical industry

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.

Key Skills & Competencies

• 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