11 Sep
|
Unichem Laboratories
|
India
11 Sep
Unichem Laboratories
India
Qualification- B.Tech / B.E. in Any Specialization
Experience- 15 to 20 Years
Job description
RESPONSIBILITIES
Budget Oversight: Prepare and monitor Revenue and Capital Expenditure (CAPA) budgets, ensuring optimum utilization.
Cost & Energy Optimization: Implement cost reduction techniques to improve productivity, and sustainability.
Resource Planning: Plan and manage labour, equipment, and materials for major engineering projects and facility operations.
Compliance Leadership: Ensure strict adherence to cGMP, FDA, and other international regulatory standards (e.g., EU, WHO, ISO).
Audit Representation: Act as the Subject Matter Expert (SME) during internal, customer and regulatory audits. (e.g., USFDA)
QMS Oversight: Manage change controls, deviations, and Corrective and Preventive Actions (CAPA) related to plant machinery and facility systems.
Plant Maintenance: Oversee all maintenance activities (preventive, predictive, and breakdown) for production equipment and critical utilities.
Utility Systems: Manage specialized pharma utility systems including HVAC,
water purification (PW/WFI), refrigeration, and clean compressed air.
Equipment Lifecycle: Lead the entire lifecycle of plant machinery, from procurement and FAT (Factory Acceptance Testing) to installation, commissioning, and validation (DQ, IQ, OQ, PQ).
Team Supervision: Lead and mentor a multi-disciplinary team of engineers and technicians, including engineering managers.
Training & Development: Design, implement and monitor technical and safety training programs to keep the team aligned with current industry standards and safety protocols.
Cross-Functional Coordination: Coordinate with Production, Quality Assurance, Quality Control, IT, and other departments.
Safety Implementation: Enforce EHS policies to maintain a secure working environment and ensure compliance with environmental regulations related to air, water, hazardous waste.
DESIRED SKILLS
Should possess sound strategic thinking and effective de
📌 Senior Engineering Manager (India)
🏢 Unichem Laboratories
📍 India