Drug Product Engineering - Senior Director

Biocon Biologics; Johor; On-site; MYR 120,000 - 180,000; Full time

Job summary

A multinational healthcare organization seeks a Senior Director of Drug Product Engineering in Johor. The role entails overseeing manufacturing equipment compliance, optimizing processes, and ensuring regulatory standards are met. Candidates should possess a relevant degree and extensive experience in drug product manufacturing. Join a purpose-driven environment committed to global healthcare innovations.

Qualifications

• 15–20 years of experience in drug product manufacturing or engineering roles.
• Strong knowledge of aseptic processing and regulatory requirements.
• Proven experience in tech transfer and equipment qualification.

Responsibilities

• Oversee preventive and corrective maintenance of manufacturing equipment.
• Lead technology transfer of new drug formulations into manufacturing.
• Ensure compliance with cGMP and regulatory guidelines.

Skills

Problem-solving

Communication

Cross-functional collaboration

Education

Bachelor’s/master’s degree in chemical engineering or Pharmaceutical Sciences

Tools

SAP

Job description

About Biocon Biologics

At Biocon Biologics, we are building a sustainable model for the future of global healthcare. As a pioneer in the biosimilars revolution, our mission is to impact a billion lives through affordable innovation, a deep commitment to patient-centricity, and a relentless pursuit of excellence. We are a multicultural, global organization driven by purpose and guided by values, committed to delivering high-quality biosimilars to patients across both developed and emerging markets.

We offer end-to-end capabilities from clone development, manufacturing, clinical development, and regulatory approvals to commercial launch.

Location – Johor, Malaysia

Job Summary

The Drug Product Engineering – Senior Director is responsible for ensuring the availability, efficiency, and compliance of drug product manufacturing equipment and facilities. This role involves overseeing preventive and corrective maintenance, driving process optimization initiatives, managing vendor relationships, supporting audits and validation activities, and contributing to overall equipment reliability and performance.

Key Responsibilities

Core Responsibilities:

• Lead and support technology transfer of new drug product formulations into manufacturing, ensuring robust scale-up from development to GMP production.

• Partner with cross-functional teams including R&D, Quality, Manufacturing, and Supply Chain to ensure seamless process implementation.

• Support selection, installation, commissioning, and qualification of equipment and systems used in drug product manufacturing (e.g., filling lines, lyophilizers, cappers, isolators, etc.).

• Conduct root cause investigations, process troubleshooting, and deviation resolution.

• Develop and review technical documents, including batch records, validation protocols, risk assessments (FMEA), SOPs, and engineering reports.

• Drive process optimization and continuous improvement using statistical tools and data analysis (e.g., CPV, Minitab).

Ensure compliance with cGMP, regulatory guidelines (FDA, EMA), and internal quality standards.

• Ensure all systems are operated and maintained in line with OEM guidelines.

• Collaborate with vendors for site servicing and technical support.

• Support commissioning, qualification, and validation (FAT, SAT, DQ, IQ, OQ, PQ) of equipment.

• Participate in facility upgrades, cost/energy optimization programs, and project activities.

• Ensure compliance with QMS and EHS standards during audits; close findings within timelines.

• Maintain accurate documentation, including SOPs, checklists, history cards, and logs.

• Plan and manage team schedules, material procurement, and shift planning.

• Utilize SAP for maintenance operations such as raising, tracking, and closing work orders.

• Prepare and review preventive maintenance schedules and evaluate vendor performance.

• Authorize work permits, invoices, and vendor contracts.

• Support team development, conduct technical evaluations, and identify training needs.

Additional Responsibilities:

• Promote a safe working environment and foster safety awareness across the team.

• Participate in internal expansion projects and ensure legal and compliance requirements are met.

• Organize external training sessions for continuous skill enhancement.

• Perform other tasks as assigned by reporting managers.

Must Have Qualification

• Bachelor’s/master’s degree in chemical engineering, Pharmaceutical Sciences, or related field.
• 15–20 years of experience in drug product (sterile/aseptic or non-sterile) manufacturing or engineering roles within the pharmaceutical/biotech industry.
• Proven experience in tech transfer, process validation (PPQ), and equipment qualification.
• Strong knowledge of aseptic processing, fill-finish operations, and regulatory requirements.
• Experience with parenteral products, biologics, or high-potency compounds is a plus.
• Strong problem-solving, communication, and cross-functional collaboration skills.

At Biocon Biologics, we believe our people are our greatest asset. If you’re passionate about making a global impact and thrive in a fast-paced, purpose-driven environment, we invite you to be part of our journey.

We are open to accepting applications from candidates based in other countries and will provide full support for international relocation, including visa sponsorship and settling-in assistance.