Senior Executive - Injectable Process Equipment Maintenance

Job Overview

This role requires extensive hands-on experience in maintaining injectable process machinery such as vial and pre-filled syringe (PFS) filling lines, isolators, lyophilizers, and steam sterilizers. The candidate will be expected to lead a team of 5 to 10 members effectively.

Key Responsibilities

• Operate and oversee maintenance activities on specialized injectable processing equipment.
• Implement, review, and manage departmental documentation, validation procedures, and Quality Management System (QMS) operations including Change Control, Investigations, and CAPA modules.
• Analyze breakdown notifications and efficiently plan and execute preventive maintenance schedules using SAP, ensuring timely completion.
• Maintain and procure essential critical spares with an innovative, budget-conscious approach, including efforts in reverse engineering.
• Collaborate and coordinate with external vendors for development and maintenance of indigenous spare parts.
• Drive continuous improvement initiatives aimed at enhancing process efficiency, energy conservation, and capacity in filling lines while upholding quality standards.
• Commit to strict compliance with current Good Manufacturing Practices (cGMP) and quality systems.
• Engage with regulatory audits from authorities like USFDA, MHRA, ANVISA, and TGA.
• Prepare department budgets and capital expenditure plans, alongside monitoring annual engineering expenses.
• Ensure all safety policies and a safe working environment for team members, contractors, and external parties are upheld.
• Ensure legal compliance regarding safety, environmental regulations, and government licensing.

Experience and Education Requirements

• 8 to 10 years of relevant experience in the field.
• Educational qualifications include a Diploma or B.Tech in Electrical or Instrumentation disciplines.

Competencies Required

• Innovation and creativity to develop efficient solutions.
• Strong customer centricity to maintain quality standards aligned with customer needs.
• Result-oriented mindset driving initiatives to completion.

Additional Information

This job is based onsite in the Greater Nagpur Area. Candidates should be prepared to work in a regulated pharmaceutical manufacturing environment and engage with international regulatory bodies.