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Purpose To manage and execute capital projects associated with OSD manufacturing equipment, HVAC systems, cleanroom infrastructure, and utility installations within pharmaceutical facilities. The position is responsible for project planning,

engineering coordination, vendor management, installation,

commissioning, qualification support, and ensuring compliance with GMP, safety, quality, and project delivery objectives.

Position / Job Title

Assistant Manager Projects, Mechanical Engineering

Department

Engineering/Technical services

Reporting To

Assistant General Manager – Engineering & Projects

Location

Pithampur

Years of Experience

09 –11 years of experience in HVAC systems within a pharmaceutical OSD facility, including project execution and validation.

Minimum 4-5 years in a Mechanical Process & HVAC

Installations Projects lead role within a pharmaceutical formulation manufacturing facility or equivalent

Dosage Form

Solid & Semi solid

Job Responsibilities /Deliverables

Project Planning & Execution

Lead execution of greenfield, brownfield, capacity expansion, and facility modification projects.

Prepare project schedules, monitor progress, and ensure timely completion within approved budgets.

Coordinate with internal stakeholders, consultants, vendors,

and contractors throughout the project lifecycle.

Monitor project risks and drive timely closure of project deliverables.

Mechanical & Process Equipment Projects

Lead installation, commissioning, and handover of OSD manufacturing equipment such as:

Dispensing Systems, Granulation Equipment, Fluid Bed Dryers (FBD), Rapid Mixer Granulators (RMG)

Compression Machines, Coating Machines, Capsule Filling Machines, Packing Equipment

Review equipment layouts and utility requirements.

Coordinate FAT, SAT, installation, and qualification activities with OEMs and validation teams.

Ensure equipment installation complies with approved drawings and GMP requirements.

HVAC & Cleanroom Projects

Coordinate design review, installation, testing, and commissioning of HVAC systems for Grade C & Grade D classified areas.

Review HVAC layouts, duct routing, airflow concepts,

pressure cascades, and cleanroom requirements.

Support AHU, Dehumidifier,



Dust Collector, Chiller, and Ventilation System projects.

Coordinate air balancing, HEPA integrity testing, and cleanroom qualification activities.

Ensure HVAC systems meet approved temperature, RH,

pressure differential, and cleanroom requirements.

Utility & Infrastructure Projects

Execute utility-related projects including:

Chiller Systems, Cooling Towers, Air Compressors, Vacuum Systems

Purified Water Systems, DG Sets.

Electrical Infrastructure

Coordinate utility integration with manufacturing and facility systems.

Support utility capacity assessment and future expansion planning.

Qualification & Validation Support

Coordinate IQ, OQ, and PQ activities for equipment, utilities,

and HVAC systems.

Review qualification protocols and reports in coordination with QA and validation teams.

Ensure project documentation is available for regulatory and

GMP compliance requirements.

Support execution of validation master plans related to projects.

Vendor & Contractor Management

Participate in technical evaluation of vendors and contractors.

Review vendor documents, GA drawings, utility requirements, and technical submissions.

Monitor site execution activities and ensure compliance with approved specifications.

Track contractor performance, quality, safety, and project milestones.

CAPEX & Project Cost Management

Assist in preparation of project budgets and CAPEX proposals.

Monitor project costs against approved budgets.

Support procurement activities through technical recommendations and bid evaluations.

Ensure optimum utilization of project resources and budgets.

Documentation & Compliance

Review URS, layout drawings, P&IDs;, equipment specifications, and engineering documents.

Ensure proper project documentation, as-built drawings,

and handover dossiers.

Support change controls, deviations,



and project-related documentation activities.

Safety & EHS

Ensure compliance with GMP, EHS, and engineering safety requirements during project execution.

Monitor contractor safety practices and permit systems.

Participate in risk assessments and project safety reviews.

Ensure compliance with LOTO, work-at-height, hot work, and confined space procedures wherever applicable.

Additional Skills & Competencies

OSD Manufacturing Equipment Projects

HVAC Systems (Grade C & D)

Utility Systems Integration

FAT / SAT / IQ / OQ Coordination

AutoCAD & Layout Review

Project Planning & Scheduling

Vendor Management

CAPEX Management

GMP, WHO, USFDA & Schedule M Awareness

MS Project

Audit Support & Continuous Improvement

Represent HVAC engineering during regulatory and customer audits.

Ensure HVAC & BMS systems remain continuously audit-

ready with updated documentation.

Lead continuous improvement initiatives for HVAC performance, energy efficiency, and compliance.

Utilities & Energy Management

Oversee operation and maintenance of utilities (HVAC,

boilers, chillers, compressors, DG sets, ETP, STP) as needed

Implement energy conservation and cost-reduction initiatives

Conduct risk assessments and ensure compliance with safety regulations

Investigate incidents and implement preventive measures.

Ensure HVAC installation and modifications meet EHS standards (LOTO, electrical safety, confined space).

Conduct risk assessments for HVAC/BMS modifications and commissioning activities.

Qualifications Education

B.E./B.Tech in Mechanical Engineering

Deep understanding of pharma cleanroom design, OSD equipment’s projects installations & regulatory compliance.

Additional notes Key Performance Indicators (KPIs)

Ensure ≥ 98% compliance of HVAC environmental parameters (Temp/RH/DP/ACH) within validated limits.

Complete 100% of HVAC & BMS/DCS qualification

(IQ/OQ/PQ) activities as per the approved validation plan.

Close all QMS records (CC/CAPA/Deviation) related to

HVAC/BMS within defined timelines (Zero overdue).

Achieve ≥ 95% on-time project milestone completion for all

HVAC & BMS/DCS engineering projects

📌 Assistant Manager (Indore)
🏢 Rubicon Research
📍 Indore