Maintenance Technician - Pharmaceutical Manufacturing
Strides Pharma Inc.
Position Summary This role focuses on equipment uptime, preventive maintenance, troubleshooting, and continuous improvement of utilities and process equipment-including tablet presses, granulation systems, and HVAC systems supporting cleanroom operations. Key Responsibilities
- Perform and oversee preventive, predictive, and corrective maintenance on pharmaceutical manufacturing and facility equipment.
- Lead troubleshooting and repair efforts on tablet presses, granulators, blenders, fluid bed dryers, coating machines , and other process equipment.
- Maintain and repair facility utilities such as HVAC systems, compressed air, purified water, steam, chilled water, and vacuum systems .
- Support calibration and mechanical integrity programs to ensure GMP compliance.
- Collaborate with Production, Engineering, and Quality departments to minimize downtime and ensure regulatory requirements are met.
- Review and update maintenance SOPs, work orders, and documentation in accordance with cGMP and FDA standards.
- Train and mentor junior technicians and provide technical guidance during shifts or project work.
- Participate in capital projects, equipment installation, and commissioning/qualification activities (IQ/OQ/PQ).
- Identify and implement process improvements to increase reliability and reduce maintenance costs.
- Support environmental monitoring and cleanroom operation standards through proper maintenance of HVAC and filtration systems.
- Education: Associate's or Bachelor's degree in Mechanical, Electrical, or Industrial Engineering (or equivalent technical discipline) preferred.
- Experience: Minimum 5-8 years in a maintenance or engineering role within a pharmaceutical, biotech, or GMP manufacturing environment.
- Strong hands-on experience with tablet compression, granulation, and packaging equipment .
- Working knowledge of HVAC systems , cleanroom environments, and associated regulatory requirements (ISO 14644, cGMP).
- Familiarity with CMMS systems (e.g.,, BMRAM, Maximo, SAP PM) and maintenance documentation practices.
- Strong understanding of electrical, mechanical, and pneumatic systems.
- Excellent problem-solving, communication, and leadership skills.
- Knowledge of PLCs and control systems troubleshooting.
- Experience with aseptic or sterile manufacturing utilities.
- Understanding of 21 CFR Part 11 and data integrity principles.
- Root cause analysis and reliability-centered maintenance experience.
Vacancy posted 3 days ago
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