JOB SUMMARY:

The Maintenance Technician / Sr. Technician supports pharmaceutical manufacturing by performing scheduled Preventative maintenance and will be responsible for maintaining and troubleshooting equipment used in the production of tablets, ointments, and nasal sprays, ensuring smooth and compliant operations within a cGMP environment.

QUALIFICATIONS:

• Education: Diploma or Technical Certificate in Mechanical/Electrical Engineering or related field.
• Experience: 2–5 years of calibration experience in a regulated pharmaceutical, biotech, or GMP manufacturing environment. Troubleshooting experience on various instruments like pressure transmitters, temperature, relative humidity sensors etc. is must.
• Minimum 3 years of experience in pharmaceutical manufacturing maintenance, preferably with exposure to solid oral dosage, topical formulations, and nasal spray equipment.
• Experience with equipment qualification (IQ/OQ/PQ) and validation documentation.
• Familiarity with preventive maintenance programs and root cause failure analysis.
• Knowledge of safety standards.
• Training/certification in Good Manufacturing Practices (GMP) is preferred.
• CERTIFICATIONS (PREFERRED):Training in USP <41>, <1251>, and <1058> practices
• SKILLS:Strong understanding of GMP, FDA 21 CFR Part 11, and data integrity principles.Working knowledge of risk/principal-based equipment / instrument classification.Excellent documentation and problem-solving skills.

PHYSICAL & WORK ENVIRONMENT REQUIREMENTS:

• Ability to work in cleanroom, lab, and utility areas following gowning and safety protocols.
• Able to lift up to 25 lbs and work on ladders, if needed.
• Occasional weekend or off-shift support may be required.

• Perform routine preventive maintenance and corrective repairs on manufacturing equipment including Granulation line, tablet compression machine, coating machines, ointment mixers, nasal spray filling machines, blister/tablet bulk packing lines and associated utilities (HVAC, compressed air, water systems).
• Troubleshoot mechanical, electrical, pneumatic, and control system faults promptly to minimize production downtime.
• Assist in installation, calibration, and qualification (IQ/OQ/PQ) of new or upgraded equipment according to cGMP and company SOPs.
• Maintain detailed maintenance logs, reports, and documentation ensuring compliance with regulatory and internal audit requirements.
• Support continuous improvement initiatives by identifying equipment reliability issues and proposing enhancements.
• Ensure adherence to safety standards, cleanroom protocols, and cGMP practices within manufacturing areas.
• Coordinate with production, quality assurance, and engineering teams for timely maintenance scheduling and equipment validation.
• Manage spare parts inventory and recommend procurement to avoid delays.
• Participate in emergency breakdown response, performing root cause analysis and implementing corrective actions.
• Maintain tools, instruments, and calibration devices, ensuring they are in proper working order and calibrated as required.
• Provide technical support during equipment inspections, audits, and regulatory visits.