Projects Clean & Black Utilities - Biosimilar

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 proven end to end expertise in the field of biosimilars, from its development, manufacturing, clinical development, regulatory approvals to commercialization. We have a long-term commitment to bring high quality affordable biosimilars to patients all over the globe.

About the Role

The candidate will Lead design, execution, and commissioning of clean and black utility systems. Responsible for equipment sizing, documentation, vendor and contractor management, site execution, and leading validation to ensure GMP compliance.

Key Responsibilities:

• Review and approve technical documents (P&IDs, GADs, piping layouts).
• Size and select equipment for clean utilities (WFI, PSG, PW, compressed air, nitrogen) and black utilities (cooling towers, boilers, raw water).
• Lead technical bid and vendor evaluations.
• Manage contractors and site activities.
• Lead project documentation and validation.
• Ensure compliance with cGMP and regulatory standards.
• Collaborate with CTF, quality, and regulatory teams.
• Monitor project progress and budgets.

Utilities Scope:

Clean: WFI, purified water, clean steam, oil-free compressed air, nitrogen, vacuum, chilled water, specialty gases.

Black: Cooling towers, utility steam boilers, wastewater treatment, fire fighting.

Qualifications:

• Bachelor’s degree in mechanical engineering.
• 8-12 years pharma experience in clean & black utilities.
• Strong in equipment sizing, documentation, vendor management, and validation leadership.
• Knowledge of cGMP and pharma regulations.
• Knowledge of HVAC is a plus.
• PMP certification preferred.