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Division

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

Job Description

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.