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Bhavya Bhavsar

@bhavyabhavsar

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Senior operations and engineering management executive leading regulated sterile facilities.

United States

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What I'm looking for

I’m looking to lead multi-site engineering and validation teams in regulated pharma/biotech, driving audit readiness, reliability, and greenfield/brownfield delivery while partnering closely with quality to strengthen compliance and performance.

I’m a Senior Operations & Engineering Management Executive with over 24 years directing multi-site industrial facility and infrastructure, clean/black utility maintenance, and equipment/system qualification under strict regulatory quality compliance.

I specialize in steering complex engineering architectures through corporate mergers, acquisitions, and international expansions—deeply grounded in sterile platforms, cleanrooms, HVAC networks, nitrogen gas, compressed air, purified water, water for injection, and pure steam.

Across pharmaceutical (injectable, infusion, OSD, external preparations, vaccines) and food processing environments, I build facility audit-readiness aligned to US-FDA, MHRA, TGA, GCC, EU GMP, and WHO expectations, using disciplined validation and reliability-centered programs.

I lead large cross-functional engineering teams and deliver end-to-end execution for high-stakes green field and brown field projects, leveraging enterprise systems (SAP PM/MM, Zoho Projects, DMS, Ample Logic, TrackWise 8) to strengthen compliance workflows and operational performance.

Experience

Work history, roles, and key accomplishments

Deputy GM, Engineering & Maintenance

Chiron Behring Vaccines Private Limited

May 2024 - May 2026 (2 years)

Served as Site Engineering Head with bottom-line accountability for a cGMP-regulated freeze-dried vaccine manufacturing facility. Led a $10.5M drug substance facility project and directed a 70-member engineering team while driving reliability-centered maintenance and regulatory audit readiness.

Project Execution Engineering Leadership Reliability Centered Maintenance (RCM)Zoho Projects DMS Ample Logic (Change Control CAPA Vendor Selection FAT

General Manager, Engineering & Maint

Troikaa Pharmaceuticals Limited

Jan 2023 - Apr 2024 (1 year 3 months)

Served as Second-in-Command for a $42M greenfield injectable plant project delivering multiple manufacturing lines. Led multi-site maintenance and a digital transformation integrating IoT-based energy management and CMMS solutions, while enforcing QMS compliance using Ample Logic.

Greenfield Project Multi Site Management Industry 4.0 Energy Management CMMS Ample Logic CAPA Change Control Cross functional Leadership Team Management

Associate GM, Engineering Services

Baxter Pharmaceuticals India Private Limited

Aug 2013 - Dec 2022 (9 years 4 months)

Managed cleanroom equipment systems and supported globally regulated sterile injectable manufacturing facility readiness. Participated in PFMEA, led remediation validations during 2020–2021, and governed QMS compliance across Change Control, CAPA, and Deviations using TrackWise 8 and related SOP guideline reviews.

Clean Utilities (PW Sterilization SCADA Fully Automatic Manufacturing Suites Filling Lines FAT GCC PFMEA Equipment Remediation & Validation GMP Compliance SOP Vs Guidelines SOP Vs Practices Trackwise Change Control CAPA Deviation Management

Executive – Maintenance

Torrent Cables Limited

Jun 2010 - Aug 2013 (3 years 2 months)

Directed capital projects, equipment maintenance, and automation engineering for a high-tension 11KV manufacturing facility. Managed Siemens automation systems and implemented 5S and TPM methodologies across the production floor.

Capital Projects Equipment Maintenance Automation Engineering 5 S Total Productive Maintenance (TPM)

Executive – Engineering Services

Claris Lifesciences Limited

Jun 2005 - Mar 2010 (4 years 9 months)

Participated in a greenfield plant project, supporting facility layout engineering and utility integration through startup of multiple manufacturing lines. Led multi-plant facility engineering and asset tracking setup in SAP PM/MM, and performed FAT for packaging and fill-finish equipment deployments.

Greenfield Project Support Plant Layout Engineering SAP PM FAT Bottelpack Machine (Rommelag)Glass Vial Fill Finish Line