20 Oct
Biotech Healthcare
Ahmedabad
Role Objective:
A key objective of this role is ensuring the continuous operation and optimal performance of plant and utility machinery within pharmaceutical or medical device manufacturing environments. The role focuses on maintaining equipment availability, utilization, and reliability while ensuring strict adherence to regulatory standards, safety protocols, and preventive maintenance practices.
Desired Candidate Profile:
1. Bachelor’s or Master’s degree in Engineering or a related field.
2. 13 to 15 years of hands-on experience in maintaining pharmaceutical or medical device manufacturing machinery.
3. Proficiency in managing diverse equipment, including steam sterilizers, DHS, filling machines, packing machines,
air compressors, water chillers, purified water systems, and similar.
4. Strong organizational skills, with experience in preventive maintenance scheduling and thorough knowledge of ISO and cGMP documentation.
5. Familiarity with FDA regulatory requirements.
6. Demonstrated experience in leading maintenance teams, interpreting technical drawings, and using relevant software for communication and documentation.
7. Extensive knowledge in instrumentation, automation, CNC machining, and robotics.
Role & Responsibilities:
1. Strategic Planning: Develop and implement comprehensive maintenance strategies to ensure the uninterrupted operation of all equipment and systems.
2. Team Leadership: Oversee the recruitment, training, and performance management of the maintenance team, fostering a culture of continuous improvement.
3. Budget Management: Prepare and manage the maintenance budget, ensuring cost control and efficient procurement of spare parts, tools, and equipment.
4. Preventive Maintenance:
Design and supervise preventive maintenance programs to reduce downtime and enhance equipment longevity.
5. Compliance & Safety: Ensure all maintenance operations meet safety standards and comply with health, environmental, and regulatory requirements.
6. Emergency Response: Implement and manage emergency response procedures to swiftly address equipment breakdowns or failures.
7. Vendor Relations: Manage relationships with external contractors and vendors, overseeing contract negotiations and ensuring the quality of work.
8. Reporting & Analysis: Monitor maintenance KPIs and provide analytical reports to senior management with recommendations for continuous improvement.
9. Project Management: Coordinate and oversee maintenance-related projects,
including machinery upgrades, repairs, and installations.
Functional Skill Required:
- Extensive hands-on experience in the operation and maintenance of pharmaceutical or medical device machinery.
- Expertise in preventive maintenance planning and execution.
- Strong knowledge of ISO, cGMP documentation, and regulatory compliance.
- Proficiency in understanding technical drawings and specifications for spare parts.
- Competency in using software tools such as Microsoft Excel and Word for documentation and reporting.
Behavioural Skill Required:
- Strong organizational and time management abilities.
- Excellent communication skills, both verbal and written, to interact with teams, vendors, and senior management.
- Leadership skills to effectively manage personnel and collaborate with external service providers.
- Problem-solving and analytical mindset to troubleshoot equipment issues and optimize performance.
- Detail-oriented approach to maintaining thorough documentation and ensuring regulatory compliance.
Team Size to be Handle:
- Position involves leading & managing a team of maintenance professionals, with direct reporting to the General Manager – Manufacturing.
Biotech is an Equal Opportunity Organization promoting diversity while ensuring no discrimination on any ground including gender, race, religion, age, sexual orientation, disability, etc.