Executive - Engineering

Piramal Pharma Ltd; India; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Piramal Pharma Solutions is seeking an Executive - Engineering to manage and supervise technical and operational control activities for Sterile and OSD lines at our site.

The role requires a Diploma/BE/BTech in Mechanical, 6–9 years of plant maintenance experience, and strong knowledge of GMP, safety and SAP PM; you will lead maintenance teams, ensure uptime, and support qualification activities.

Qualifications

• Diploma / BE / BTech in Mechanical engineering.
• 6-9 years of relevant experience in OSD plant maintenance.
• Knowledge of OSD formulation and sterile machinery.
• Familiar with cGMP and safety requirements.

Responsibilities

• Lead and provide engineering support to plant equipment.
• Reduce repeated breakdowns and improve reliability.
• Plan and allocate maintenance work on shift basis.
• Ensure no machine stoppages due to manpower issues.
• Perform preventive and breakdown maintenance per SOP.
• Comply with regulatory and safety requirements.
• Maintain cGMP documentation.
• Provide on-job training to workers.
• Support qualification/validation activities.

Skills

Equipment operation

Preventive maintenance

Troubleshooting

Shift coordination

Leadership

Education

Diploma/BE/BTech in Mechanical

Tools

SAP PM

Job description

Division

Piramal Pharma Solutions

Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia.

This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation.

Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide.

For more details, please visit : www.piramalpharmasolutions.com

Job Title

Executive - Engineering

Job Description

Should have knowledge of OSD formulation and sterile machineries. Core experience requirement is OSD Plant maintenance.

Purpose of Job

• To perform and supervise technical and operational control activities for Sterile and OSD line.

• To perform and supervise technical and operational control activities for other Plant Machines and Systems

• To maintain best practices to ensure compliance of cGMP and safety requirements.

• To ensure shift operations in plant engineering, maintaining good housekeeping and ensuring safe and Good Engineering practices.

Key stakeholders

External - Vendors and Suppliers

Internal - Production, Engineering, QA, QC, Stores, Validation, HR, Finance, EHS.

Reporting structure

Role directly reports to- Deputy chief Manager - Engineering

Positions that report into this role - Workmen

Essential Qualifications

Diploma / BE / BTech in Mechanical branch

Essential Experience

Minimum 6-9 years of experience

Essential Skills: knowledge of Equipment functioning, Preventive Maintenance of equipment and operation, setting and repairing/maintenance of plant equipment, system and machines. Knowledge of Utility Equipment, operations and troubleshooting.

Desirable Skills: Work Planning, Scheduling, Communication, Computers, Troubleshooting, understanding of Machine Drawings, usage of measuring Instruments, Leadership skills.

Job Conditions

Shift rotation with overstay as per work requirements.

Key Roles/Responsibilities:

• To work as a group leader and responsible for providing immediate engineering support to plant equipment.
• To ensure reduction of repetitive types of breakdowns in Plant Equipment.
• To develop skill and efficiency of self and others as per the requirement.
• To allocates workmen for different maintenance jobs on shift-to-shift basis and ensure handover of charge to next shift executive.
• To ensure no stoppage of machines due to non-availability of man power or breakdown.
• To perform QMS activities, usage of ENSUR and SAP PM Module.
• To perform Preventive and breakdown maintenance along with general and schedule maintenance activity as per SOP.
• Comply with various regulatory and safety requirements pertaining to engineering activities.
• Maintains cGMP practices along with documentation in various records.
• Imparts on job/ Classroom training to the concern workmen for engineering SOP.
• Imparts induction activity to all new joining.
• To participate in qualification & requalification of machine/equipment and functional support for qualification, validation and calibration activity.
• Monitors and reports the unauthorized movement of workmen from line and ensure discipline.
• Takes up the responsibilities of the immediate supervisor for the section in his absence.
• Making purchase requisitions in SAP system. (If SAP user id is available).
• Active participation in DMS, OE and EHS activities and engagement in the process.
• To keep awareness of operational standards (ISO 14001, ISO 45001 & 13485).
• To follow the regulations of various agencies (USFDA, EU, TGA, MHRA, ANVISA, WHO, Schedule M etc.).
• To execute CAPA, project and area renovation works and aid qualification activities.
• Identify area of energy conservation and take measures for efficient utilization of energy.
• To keep Engineering Manager informed of plant maintenance activities.
• To coordinate, extend support and report with plant maintenance shift executive/ manager for any maintenance requirement with respect to engineering services.