Executive,Engineering & Maintenance

APOTEX; Bengaluru; On-site; INR 900,000 - 1,300,000; Full time

Job summary

APOTEX is seeking a Mechanical Engineer with GMP experience to oversee operation and maintenance of utility systems (HVAC, BMS, EMS, BAS) and related equipment in a Bengaluru facility. The role emphasizes regulatory compliance, documentation, and cross-functional collaboration with QA and EHS teams.

Ideal candidate has a BE in Mechanical Engineering, ~6.5 years of GMP pharma experience, and strong knowledge of QMS, energy management, and SAP-based maintenance workflows.

Qualifications

• Meets GMP regulatory and quality requirements.
• Strong documentation and record-keeping ability (QMS).
• Experience with SAP and maintenance planning.

Responsibilities

• Ensure uninterrupted, compliant operation of HVAC, utility systems and related equipment.
• Adhere to utility operation and maintenance procedures and ensure proper documentation.
• Coordinate with EHS for safe workplace and regulatory compliance.
• Train contract staff on cGMP, regulatory expectations, and equipment tech updates.
• Plan and execute engineering activities, changes, and facility modifications per cGMP.
• Maintain online documentation and ensure timely completion of PM work orders in SAP.

Skills

Engineering compliance

Interpersonal skills

QMS knowledge

Project delivery

Cost reduction

Education

Bachelor of Engineering in Mechanical Engineering

Tools

SAP

Job description

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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.

Operation and Maintenance activities of utilities system, Installation, Modification, Repair, Planning and executing upcoming projects, online documentation and review of documentation as needed or requested by the organization.

Job Responsibilities

• Ensuring and supporting to ARPL cross functional team or Uninterrupted supply of clean Utilities without any breakdowns and operates in full compliance with, all regulatory requirements and according to established safety norms.
• Ensure adherence to utility operation & maintenance procedures and good documentation practices are performed/followed all the time as per the established ARPL standards and maintain safe workplace at ARPL all time in coordination with EHS Personnel.
• Ensure the operation and maintenance of HVAC, BMS, EMS, BAS, water plant, Boiler, Chiller, AC and other utilities systems.
• Ensure trainings are attended on-time and ensure trained before working on the machine. Train the contract employees on cGMP, Regulatory, Latest Technical & industrial developments related to Engineering. Ensure adherence of team members with all compliance programs and company policies and procedures.
• Plan & work towards the target set by the management based on business needs. Plan/Execute/Coordinate/Qualify Upcoming Engineering related activities/Projects/facility changes/modification in line with cGMP.
• Manage and provide technical for utility contract employees and to ensure for all the equipment's online documentation are maintained all the time with respect to Equipment Qualification/Re Qualification/Re- evaluation/ Risk Assessment/CAPA/CCR.
• Providing support for on time closure of QMS elements like Change control, CAPA, Deviation and Effectiveness monitoring.
• Preparation/Initiate/Reviewing & Implementation of SOPs/URS/Equipment Qualification/Planner/Protocol/relevant formats/Logbook/Schedule/Layouts/Drawings/
• Laise with QA Department to co-ordinate for the preparation, development and implementation of SOPs, qualifications and staff training programs related to utility system.
• To conduct periodic plant energy audits to improve the efficiency of the system, bring down the operation cost & comply with cGMP requirements.
• Coordinate with internal team for periodic calibration of various instruments & equipment to be performed as per approved schedule. Coordinate to complete online preventive and breakdown maintenance.
• Responsible for ensuring logging & closure of work requests, Breakdowns in SAP and archiving the documents for future reference. And update PM work orders in SAP.
• Goal setting as per organisation requirement & annual review. Providing the same to reporting head for review and approval.
• Demonstrate Behaviours that exhibit our four organizational Values: Collaboration, Courage, Perseverance, and Passion.
• All other relevant duties as assigned.

Job Requirements

• Education
  • Bachelor of Engineering in Mechanical Engineering.
• Knowledge, Skills and Abilities
  • Works effectively towards achieving the engineering compliance.
  • Should have good interpersonal and communicational skills.
  • Should have adequate knowledge and skills in QMS activities.
  • Strives to drive projects related to engineering.
  • Energy conservation and reducing operation cost.
  • Should have good knowledge in SAP.
• Experience
  • 6.5 years of experience in GMP regulated pharmaceutical company.

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.