Senior Associate Manager, Process and Instrumental Engineering

Senior Associate Manager, Process and Instrumental Engineering

Novugen is a wholly owned subsidiary company of a UAE based group, SciTech International. With over 30 years of experience in the healthcare industry, the company is equipped with vast and successful experience of venturing into strategic healthcare businesses and development of world-class healthcare facilities around the globe. Novugen’s passion for science and bold global strategy prepared us to respond to challenges of bringing hard-to-source and technology-intensive pharmaceutical products to the market.

Novugen specializes in niche and difficult to formulate generics for all therapeutic areas of pharmaceutical and oncology drug products while meeting stringent global quality standards. With vertical integration from Active Pharmaceutical Ingredients (API) to Finished Products R&D and manufacturing based in Malaysia, it gives us greater control over the supply chain. Our pharmaceutical and oncology manufacturing facilities in Bandar Enstek, Negeri Sembilan are the first in Malaysia and the only in Southeast Asia with approval from USFDA.

The people behind Novugen are professionals coming from diverse backgrounds and nationalities from all over the world, working together to achieve one common goal. We are committed to ensuring early access to high-quality products that lack robust generic alternatives due to their complexity.

About the role

We are seeking a highly motivated and experienced professional to lead the Process & Instrumentation Engineering team. The Senior Associate Manager / Associate Manager will be responsible for overseeing daily operations, ensuring optimal performance of Oral Solid Dosage (OSD) manufacturing processes, equipment, and instrumentation systems. This role demands a deep understanding of OSD technologies, process optimization, and regulatory compliance within a pharmaceutical manufacturing environment.

Key Responsibilities

• Oversee installation, qualification (IQ / OQ / PQ), and maintenance of OSD equipment : Granulations, blenders, Compressions, Capsule, Coating, Spray Dryer, Blister & Bottle Packaging.
• Ensure equipment maintenance / performance aligns with GMP and regulatory requirements.
• Lead troubleshooting and root cause analysis for equipment failures or deviations.
• Develop and implement preventive and predictive maintenance programs.
• Maintain calibration schedules and ensure traceability of all critical instruments.
• Ensure all documentation complies with GMP, GDP, and data integrity standards.
• Manage change controls, CAPAs, and deviations related to equipment and instrumentation.
• Prepare for and support regulatory inspections and internal audits.
• Assess risk and develop mitigation plans for equipment-related failures.
• Align equipment upgrades with business goals and regulatory trends.
• Work closely with QA, Validation, Manufacturing, and cross-functional team.
• Coordinate with external vendors and contractors for equipment services and upgrades.
• Provide training and mentorship to subordinates.
• Participate in CAPEX project planning and execution related to Equipment to ensure alignment with strategic business goals, cost control, and timely delivery.
• Participate in Factory Acceptance Testing (FAT) for new equipment to ensure compliance with technical specifications, operational functionality, and quality standards prior to commissioning.

About you

Bachelor’s degree in electrical, Electronics, Mechatronics or equivalent.

Minimum 5 years of related working experience in OSD Good Manufacturing Practices (GMP) environment.

Strong knowledge of process equipment and instrumentation used in OSD manufacturing setup.

Proven leadership and team management skills.

Experience with GMP compliance and regulatory guidelines.

Physical stamina and the ability to work in various environmental conditions.

Strong mechanical aptitude, problem-solving and cost management mindset.

Demonstrated strong coordination and collaboration skills through effective teamwork and clear communication.

High level of integrity and professionalism.

Adaptable to changing priorities and able to manage multiple stakeholders effectively.

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