DGM - Engineering Head (OSD)
Sun Pharmaceuticals, Inc
**Job Title:**
DMG - Engineering
**Business Unit:**
Global Quality & Compliance
**Job Grade**
G8
**Location :**
Dadra
At Sun Pharma, we commit to helping you Create your own sunshine by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.
**Are You Ready to Create Your Own Sunshine?**
As you enter the Sun Pharma world, youll find yourself becoming Better every day through continuous progress. Exhibit self-drive as you Take charge and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we Thrive together and support each others journeys.
**Job Summary :**
Lead the end-to-end Engineering function for a USFDA-approved OSD facilitycovering **maintenance, utilities, projects, reliability, automation and calibration** to ensure **cGMP compliant, safe, efficient, and reliable** operations. Drive asset performance, regulatory readiness, and continuous improvement while enabling capacity growth and cost optimization.
**Key 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 exclusively in the Pharma Industry, with specific experience in Oral Solid Facility operations.
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.
4. 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 departments.
**Travel Estimate**
**Job Requirements**
**Educational Qualification**
**B.E./B.Tech** in Mechanical/Electrical/Instrumentation.
**Experience**
_Tenure_ : **18+ years** total experience with **8+ years in OSD engineering/maintenance** **;** at least **2 USFDA/Regulatory audits** exposure as Engineering Head
**Your Success Matters to Us**
At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. _Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Lets create a brighter future together!_
**_Disclaimer:_** _The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s)._
We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.
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