Engineering Head (Project Head) - Mechanical

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Department:

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Experience Required:

Education:

Position Summary:

Engineering Head (Project Head) – Mechanical

Key Responsibilities:

Project Planning & Execution:

• Develop and manage comprehensive project implementation plans including timelines, budgets (CAPEX), and resource allocation.
• Ensure project execution adheres to approved scope; manage and document any scope changes in line with change control protocols.

Documentation & Compliance:

• Maintain complete project documentation including URS, technical specifications, validation documents (DQ, IQ, OQ), and statutory approvals.
• Ensure compliance with cGMP, GEP, FDA/MHRA guidelines, and internal QA standards throughout the project lifecycle.

Site Management & Commissioning:

• Supervise site activities during equipment installation, utility integration, and mechanical commissioning.
• Validate equipment layouts and ensure alignment with cleanroom design, HVAC zoning, and utility readiness.
• Oversee pre-installation checks, alignment, and trial runs as per approved qualification protocols.

Cross-Functional Coordination:

• Collaborate with departments such as QA, QC, EHS, Production, Validation, and Procurement for seamless project integration.
• Liaise with regulatory bodies (GPCB/CPCB) for environmental and safety compliance.

Vendor & Contractor Management:

• Monitor vendor/contractor performance and ensure adherence to SOPs, contract terms, and quality standards.
• Track BOQ vs actual material usage and maintain traceable records for audits.

Performance Monitoring & Close-Out:

• Track KPIs such as project budget variance, schedule adherence, deviation tracking, and compliance metrics.
• Conduct post-project reviews and drive learnings into future projects.
• Ensure proper project close-out including SOP handover, staff training documentation, and final utility validation.

Authority:

• Stop production/packing activities if cGMP non-compliance is observed (after consulting QA leadership).
• Issue and close non-compliance reports and ensure implementation of corrective/preventive actions (CAPA).
• Approve mechanical inspection reports, installation certificates, and vendor performance summaries.
• Recommend design/material changes to improve quality, compliance, or project efficiency.
• Approve/reject mechanical works not aligned with approved layouts or utility standards.
• Escalate critical vendor-related delays or compliance issues to senior project leadership.

Technical Skills:

Deep knowledge of pharmaceutical project engineering including:

• HVAC systems design for classified areas
• Clean utility systems (PW, WFI, Clean Steam, Compressed Air, Nitrogen)
• Black utilities (Chilled Water, Steam, AHUs, etc.)
• Strong ability to read and interpret mechanical drawings, P&IDs, and BOQs.
• Experience with equipment layout validation and utility alignment in GMP zones.
• Proficiency in MS Project, AutoCAD, MS Excel, and ERP systems (SAP or equivalent).
• Skilled in preparing and reviewing DQ, IQ, OQ documentation in collaboration with QA/Validation.
• Familiarity with regulatory inspection requirements (e.g., USFDA, EU, WHO, PIC/S).

Behavioural Competencies:

• Ownership mindset with strong accountability for GMP-compliant project execution.
• High attention to detail, especially in equipment alignment, zoning, and installation quality.
• Strong decision-making and problem-solving skills under pressure.
• Effective cross-functional collaboration and stakeholder management.
• Rigor in documentation, adherence to timelines, and audit readiness.
• Proactive communication and escalation of risks or deviations.
• Commitment to safety, compliance, and continuous improvement.

Preferred Industry Background:

• Pharmaceutical formulations (OSD, injectables, oncology, or biotech)
• API plants with regulated market orientation (USFDA/EU)
• Greenfield/Brownfield project experience in regulated environments