Officer - Engineering & Maintenance

Apotex Inc.; Bengaluru; On-site; INR 700,000 - 1,000,000; Full time

Job summary

Apotex Inc. in Bengaluru seeks a Maintenance Engineer to manage technicians, execute PM activities, and execute maintenance projects in a cGMP environment.

The role includes training new technicians, preparing SOPs, and maintaining quality documentation in SAP and related systems. The ideal candidate has a Diploma or Bachelors in Mechanical/Electrical/Instrumentation Engineering with 3+ years in pharma equipment maintenance, exposure to OSD processes, and strong communication skills.

Qualifications

• Degree or diploma in mechanical/electrical/instrumentation engineering required.
• Minimum 3 years of industry experience in OSD formulation production equipment (wet granulation, compression, etc.).
• Experience with fully automated production equipment; exposure to KORSCH, GEA machines and Gerties Roll Compactor is an added advantage.
• Strong interpersonal, writing and communication skills; knowledge of SAP PM/MM; and familiarity with QMS activities.

Responsibilities

• Execute engineering operations per ARPL standards and procedures.
• Adhere to cGMP procedures and company safety/quality standards.
• Maintain preventive maintenance schedules, calibration, and Good Documentation Practices.
• Coordinate maintenance with user departments and vendors; supervise contractors as needed.
• Prepare and review SOPs, formats, QMS, and GMP-related documentation.
• Train new technicians for maintenance activities and ensure training compliance.

Skills

GMP knowledge

GDP documents

SAP PM

SAP MM

QMS knowledge

Excel

MS Project

Project management

Interpersonal skills

Regulatory audits

Troubleshooting automated equipment

Communication skills

Engineering change management

Instrumentation knowledge

Education

Diploma/Bachelor of Mechanical/Electrical/Instrumentation Engineering

Tools

SAP PM

SAP MM

Excel

MS Project

Job description

About Apotex Inc.

Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions.

About Apotex Inc.

Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions.

For more information visit: www.apotex.com.

Job Summary

Responsible for allocation of work to the technicians in shifts and ensuring completion of activity. Ensuring /Performing PM activities of Process equipment’s within the specified limit and updation of work orders online. As per maintenance work request / corrective maintenance work orders , completion of the activity within the time line. To give training to new technicians for maintenance activities.Responsible for Preparation and review of SOPs and relevant Formats, QMS and other Engineering GMP activities and other activities as assigned. To maintain relevant log books as per cGMP standards. Installation, modification, repair, planning and executing upcoming projects, Qualification, online documentation, preparation of documents and review of documents as per SOP

Job Responsibilities

• Execute all engineering operations as per established ARPL standards and procedures.
• Adhering to cGMP procedures as per the company policy.
• Compliance to Safety & Quality standards maintained within the company.
• Adherence to the departmental procedures.
• Complaince to the Online Documentation and Good Documentation Practices.
• Adherence to the Preventive Maintenenace schedule, AMC Schedule and ensuring the quality compliance.
• Execution of Preventive Maintenance of Process, Packing, Warehouse, Microbiology Equipments as per the approved schedule.
• Handling the Maintenance related activities within the process area and in service areas.
• Ensuring completion of Maintenance Work Request in co-ordination with user department.
• Work Request Printing , Confirmation for PM and Corrective Maintenance in SAP-PM Module.
• Carrying out the AMC of machines in coordination with vendor as per the schedule.
• Ensuring the execution of all scheduled Preventive Maintenance of equipment’s are performed within defined time limits as per the approved schedule.
• Monitor in co-ordination with the user departments for maintenance issues / problems and ensuring completion of maintenance requests / corrective maintenance work orders.
• Executing / Supervise with the help of contractor’s on daily basis for follow up and completion of maintenance activities.
• Ensuring and maintaining engineering inventory management / up keep of minimum stock availability for engineering spares.
• Execute / supervise / monitor with the help of external agencies for periodic calibration of various instruments & equipment’s.
• Prepare / Check and review planned preventive maintenance schedules, validation protocols and reports in line with the cGMP requirements.
• Providing all required maintenance support to ARPL as per the departments requirements and operates in full compliance with all regulatory requirements and according to established safety norms.
• As per requirement creating material management requisition in SAP for material procurement related to process engineering.
• Plan/Execute / Coordinate / maintain Quality in upcoming engineering projects in line with the cGMP and organization requirements
• Regular checks on “My Training Plan” and ensuring the adherence to training requirement as applicable.
• Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
• All other relevant duties as assigned

Job Requirements

• Education
  • Diploma/Bachelor of Mechanical/Electrical/Instrumentation Engineering
• Knowledge, Skills and Abilities
  • Should have good knowledge in engineering activities and handling the GDP and GMP documents.
  • Minimum 3 year experience in industry hands on experience in OSD formulation Production equipment (Wet Granulation, Compaction, Compression, Capsule filling and Coating).
  • Capable of managing and troubleshooting of fully automated production equipment. Exposure on Compression – KORSCH and GEA machines and Gerties Roll Compactor will be added advantage.
  • Should have good interpersonal, writing and communicational skills
  • Should have good knowledge in Engineering change management.
  • Should have sound Knowledge in SAP PM/ MM modules.
  • Should have adequate knowledge and skills in QMS activities.
  • Should have Hands on experience in SAP, Excel, MS project etc.
  • Strives to drive projects related to engineering.
  • Skills in Project and Plant Maintenance.
  • Should have exposure to any of the regulatory audits like USFDA, MHRA, HC, TGA.
• Experience
  • 1-2 years experience in pharmaceutical industry

At Apotex, we are committed to fostering a welcoming andaccessible work environment, where all everyone feels valued, respected, and supported to succeed.

We offer accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.