Senior Manager – Instrumentation & Automation

Biocon Biologics; Johor; On-site; MYR 200,000 - 250,000; Full time

Job summary

Biocon Biologics seeks an Engineering Lead for their Johor facility. The role involves directing plant maintenance, ensuring compliance, and optimizing processes within a collaborative environment. With a focus on quality and safety, this position offers the opportunity to impact operations and mentor a dedicated team.

Qualifications

• 10+ years of experience required.
• Strong interpersonal and communication skills.
• Experience working with multidisciplinary teams.

Responsibilities

• Direct and coordinate plant maintenance operations within company policies.
• Implement and ensure compliance to quality systems and EHS.
• Lead EM Drug Substance functions for smooth operations.

Skills

plant maintenance operations

EHS

Good Engineering Practices

annual CAPEX and OPEX budgets

process optimization

calibration

validation

qualification and requalification

Brown/ Green field projects

maintenance of spares of all critical equipment

Tools

SAP

Microsoft BI tools

automation tools

Job description

At Biocon Biologics, we are creating a model for the future of healthcare for all. We are a leading company in the biosimilars revolution where patients come first. Our ambition is to impact a billion lives and we do this by fostering a culture of affordable innovation, patient-centricity, and disruptive thinking. We are a multicultural global company where employees have a purpose and passion to work closely with partners and patients. We have a long-term commitment to bringing high-quality affordable biosimilars to patients all over the globe. We have proven end-to-end expertise from clone development, manufacturing, clinical development, and regulatory approvals to commercialization.

Required Experience - 10+ Years.

Location - Johore, Malaysia.

CTC - Up to RM 20K per month

Key Skills - plant maintenance operations, EHS, Good Engineering Practices, annual CAPEX and OPEX budgets, maintenance of spares of all critical equipment, planned preventive maintenance, calibration, validation, qualification and requalification, Brown/ Green field projects, process optimization, plant/ equipment up-gradation.

Role - Drug Substance - Engineering Lead.

Roles and Responsibilities:

1. Direct and coordinate plant maintenance operations within company policies and procedures.
2. Implement and ensure compliance to quality system.
3. Implement and ensure compliance to EHS and ensure safe working environment and highlight safety needs.
4. Review and approve calibration and validation planner and reports.
5. Plan and update operational issues related to EM to ensure timely resolution without affecting production.
6. Write, review or approve documents related to EM and ensure their strict implementation.
7. Conduct employee performance reviews.
8. Reduce plant downtime through careful planning and maintenance practices for all equipment.
9. Enable knowledge sharing, identify training needs for staff, allocate engineers in shifts, and update in SAP. Design, plan, and execute new projects/modifications.
10. Support EM-related activities for drug product, drug substance, utility, R&D, and facility.
11. Lead EM Drug Substance functions to ensure smooth, safe, and uninterrupted operations.
12. Implement Good Engineering Practices and Policies organization-wide. Track and ensure closure of all OMS elements.
13. Prepare and propose annual CAPEX and OPEX budgets, ensuring spending within limits, and develop budgets for maintenance improvements. Implement cost-saving measures without compromising quality and productivity.
14. Maintain spares of all critical equipment in Drug Substance at all times.
15. Ensure completion of planned preventive maintenance, calibration, validation, qualification, and requalification activities as per annual plans.
16. Support, review, and approve commissioning & validation activities including FAT/SAT/DO/IO/OO and PO.
17. Recruit, manage, and mentor EM Drug Substance personnel to maintain an effective team.
18. Keep management updated on critical data regarding Drug Substance plant/equipment and suggest improvements or corrective actions.
19. Ensure EM team follows quality SOPs and procedures, reduce engineering deviations, provide CAPAs, propose change controls, and participate in qualifications and validations.
20. Carry out Brown/Green field projects, process optimization, and plant/equipment upgrades as required.

Behavioral/Managerial skills:

• Excellent business partnership skills.
• Good analytical abilities.
• Ability to analyze business performance and identify trends.
• Exposure to SAP, Microsoft BI tools, and automation tools.
• Strong interpersonal and communication skills.
• Experience working with multidisciplinary teams.

Biocon Biologics is an Equal Opportunity Employer committed to diversity. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex (including pregnancy), national origin, disability, genetic information, veteran status, or other protected characteristics.