Engineering Head (Project Head) - Mechanical

Location: Kadi, Ahmedabad Department: Engineering / Projects Reports to: Director – Projects / Head – Engineering / Site Head Experience Required: 12+ years in mechanical project engineering within the pharmaceutical or regulated manufacturing sector Education: B.E./B.Tech in Mechanical Engineering; PMP certification or equivalent project management credentials preferred Position Summary: We are seeking an experienced and detail-oriented Engineering Head (Project Head) – Mechanical to lead mechanical project execution in a GMP-regulated pharmaceutical environment. The ideal candidate will be responsible for managing end-to-end mechanical scope – from planning and design validation through installation, commissioning, and project handover – while ensuring full compliance with cGMP, GEP, and regulatory guidelines. 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