16 Oct
|
Pelltech Healthcare
|
Mumbai
16 Oct
Pelltech Healthcare
Mumbai
Job Title: Assistant Manager - Engineering
Company: Pelltech HealthCare Pvt. Ltd.
Experience: 8 - 12 Years
Department: Engineering
Industry: Pharmaceutical Manufacturing Formulation Plant
Job Summary
We are looking for an experienced Engineering professional to manage plant engineering operations, maintenance, utilities, regulatory compliance, and engineering projects. The ideal candidate should have solid expertise in pharmaceutical formulation plants, automated equipment, HVAC, utilities, and independent handling of regulatory audits.
Key Responsibilities
- Manage maintenance and operations of process equipment, HVAC systems, and plant utilities.
- Plan and execute preventive maintenance, breakdown maintenance, and plant shutdown activities.
- Monitor HVAC systems, temperature, relative humidity, and automated control systems.
- Ensure smooth functioning of utilities, including potable water, steam, compressed air, and vacuum systems.
- Handle engineering projects, capital expenditure proposals, equipment modifications, and facility upgrades.
- Ensure compliance with cGMP, SOPs, regulatory requirements, and engineering documentation.
- Coordinate equipment validation, qualification, calibration, and temperature mapping activities.
- Maintain audit readiness and ensure timely closure of CAPA, deviations, change controls, and other QMS activities.
- Manage engineering manpower, contractors, vendors, inventory, and critical spare parts.
- Implement cost-saving initiatives, energy conservation measures, Lean, 5S, and Kaizen practices.
- Ensure adherence to EHS requirements, electrical safety, work permit systems, and risk assessments.
- Lead and train the engineering team to improve operational efficiency and compliance.
Candidate Requirements
- 8–12 years of relevant experience in the Engineering Department of a pharmaceutical formulation plant.
- Strong knowledge of electrical maintenance, automated equipment, HVAC, and utility systems.
- Experience in independently managing engineering operations and teams.
- Must have handled regulatory audits, including USFDA, MHRA, TGA, and EU.
- Minimum 4–5 instances of regulatory audit exposure, as specified in the JD.
- Good understanding of cGMP, engineering documentation, validation, qualification, calibration, and QMS.
- Strong leadership, vendor management, troubleshooting, and project execution skills.
- Should have good exposure in Formulation plant , DG Sets, Air compressor, HVAC, Chiller, Chill water , Electrical
Interested candidates can apply through Naukri or share their updated CV for further consideration.
📌 Assistant Manager - Engineering (Mumbai)
🏢 Pelltech Healthcare
📍 Mumbai