Site Engineering Head - OSD

Job Summary

We are looking for Site Engineering for our Dadra facility (OSD - Formulation) at DGM grade

Company : Sun Pharmaceutical Industries Ltd

Location: Dadra

Position : DGM Engineering

Education : BE/B.Tech (Mechanical Full time)

Roles & Responsibilities :

• Managing maintenance for OSD utilities, plant equipment, electrical systems, instrumentation, calibration, HVAC, civil design, and overseeing overall site engineering operations, with expertise in handling large volume projects.
• Leading engineering team, overseeing technical bid analysis, budget preparation, and comparing equipment specifications, encompassing electrical and instrumentation. Reviewing P&ID drawings.
• Proactively identifying breakdown-prone areas and implementing preventive measures, while also maintaining root cause analysis reports to prevent recurrence.
• Providing guidance to the QMS team for deviation investigation, change control, and CAPA implementations.
• Managing equipment, HVAC, and utility qualification/validation, as well as overseeing requalification processes.
• Ensuring strict compliance with cGMP and USFDA standards for safety and environmental practices.
• Conducting activities related to material and energy balances, conceptual layouts, and overseeing system audits.
• Implementing various safety measures to minimize incidents and documenting conceptual details through monthly safety meetings.
• In charge of handling breakdowns, ensuring preventive maintenance as per schedule, and implementing necessary technical modifications in utility, packing, and process equipment.
• Accountable for monthly reports on plant efficiency and breakdown analysis.
• Accountable for various cGMP audits and compliance assessments, including those conducted by USFDA.
• In charge of Computerized System Validation (CSV) in accordance with GAMP 5 standards.

Candidate Profile:

• Preferred candidate should have a background Pharma Industry / FMCG
• Preferred candidate should have experience in managing engineering and maintenance activities for a Large Volume block.
• Desired candidate should possess exposure to regulatory audits, specifically with experience in USFDA audits.

This is a team leadership position, and the ideal candidate should have a track record of managing a team of 50-60 individuals across engineering and maintenance department

Experience : 18 to 20 Years experience from Pharma formulation.