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 :

1. 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.
2. Leading engineering team, overseeing technical bid analysis, budget preparation, and comparing equipment specifications, encompassing electrical and instrumentation. Reviewing P&ID drawings.
3. Proactively identifying breakdown-prone areas and implementing preventive measures, while also maintaining root cause analysis reports to prevent recurrence.
4. Providing guidance to the QMS team for deviation investigation, change control, and CAPA implementations.
5. Managing equipment, HVAC, and utility qualification/validation, as well as overseeing requalification processes.
6. Ensuring strict compliance with cGMP and USFDA standards for safety and environmental practices.
7. Conducting activities related to material and energy balances, conceptual layouts, and overseeing system audits.
8. Implementing various safety measures to minimize incidents and documenting conceptual details through monthly safety meetings.
9. In charge of handling breakdowns, ensuring preventive maintenance as per schedule, and implementing necessary technical modifications in utility, packing, and process equipment.
10. Accountable for monthly reports on plant efficiency and breakdown analysis.
11. Accountable for various cGMP audits and compliance assessments, including those conducted by USFDA.
12. In charge of Computerized System Validation (CSV) in accordance with GAMP 5 standards.

Candidate Profile:

1. Preferred candidate should have a background Pharma Industry / FMCG
2. Preferred candidate should have experience in managing engineering and maintenance activities for a Large Volume block.
3. 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.