Granules Pharmaceuticals Inc.
Pharmaceutical Maintenance Engineer (Oral Solid Dosage)
Granules Pharmaceuticals Inc., Chantilly, Virginia, United States, 22021
Description
Granules Pharmaceuticals, Inc. Granules Pharmaceuticals Inc., (GPI) is a subsidiary of Granules India LTD. Over the past 34 years, we have worked towards strengthening our core and we are currently the 10th fastest growing generic pharma company in the US!
With our sites in Chantilly and Manassas, Virginia, we have R&D through manufacturing and packaging of our medicines including pulsatile drug release in tablet and capsule dosage form, orally disintegrating modified release tablets (XR, MR, ER), modified release suspension and controlled substances capabilities in an abuse deterrent technology platform.
We are dedicated to excellence in manufacturing, quality, and commercialization of generic drugs to give customers reliable and affordable options.
Job Summary We are seeking a skilled and proactive
Maintenance Engineer
with experience in the
oral solid dosage (OSD) pharmaceutical industry . The ideal candidate will be responsible for ensuring reliable operation, maintenance, and continuous improvement of manufacturing equipment and facility systems to support safe, compliant, and efficient production.
Key Responsibilities
Perform preventive, predictive, and corrective maintenance on solid oral dosage equipment, including:
Blenders, granulators, mills.
Tablet presses and capsule fillers
Coating machines.
Packaging lines (bottle, blister, cartoners)
Troubleshoot mechanical, electrical, pneumatic, and automation issues to minimize downtime.
Support equipment installation, commissioning, qualification (IQ/OQ), and validation activities.
Maintain accurate maintenance records, work orders, and equipment logs in the CMMS system.
Ensure all maintenance activities comply with cGMP, safety, and regulatory requirements.
Collaborate with Production, Quality, and Engineering teams to resolve equipment-related issues.
Participate in root cause analysis (RCA) and implement corrective and preventive actions (CAPA).
Identify opportunities for equipment upgrades, reliability improvements, and process optimization.
Support audits, inspections, and documentation requests from QA and regulatory bodies.
Ensure spare parts inventory is maintained and managed effectively.
Qualifications
Bachelor’s degree in mechanical, Electrical, Industrial, or related Engineering field (or equivalent experience).
4+ years of maintenance experience in a
pharmaceutical oral solid dosage
manufacturing environment.
Strong understanding of cGMP, FDA, and safety regulations.
Hands-on experience with tablet compression, encapsulation, granulation, and coating equipment.
Ability to read mechanical drawings, electrical schematics, and equipment manuals.
Experience with CMMS systems and maintenance documentation.
Strong troubleshooting, analytical, and problem-solving skills.
Ability to work independently and in cross-functional teams.
Preferred Skills
Experience with automation systems (PLC, HMI, SCADA).
Knowledge of HVAC compressed air, and utility systems.
Familiarity with lean manufacturing and reliability engineering principles
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Granules Pharmaceuticals, Inc. Granules Pharmaceuticals Inc., (GPI) is a subsidiary of Granules India LTD. Over the past 34 years, we have worked towards strengthening our core and we are currently the 10th fastest growing generic pharma company in the US!
With our sites in Chantilly and Manassas, Virginia, we have R&D through manufacturing and packaging of our medicines including pulsatile drug release in tablet and capsule dosage form, orally disintegrating modified release tablets (XR, MR, ER), modified release suspension and controlled substances capabilities in an abuse deterrent technology platform.
We are dedicated to excellence in manufacturing, quality, and commercialization of generic drugs to give customers reliable and affordable options.
Job Summary We are seeking a skilled and proactive
Maintenance Engineer
with experience in the
oral solid dosage (OSD) pharmaceutical industry . The ideal candidate will be responsible for ensuring reliable operation, maintenance, and continuous improvement of manufacturing equipment and facility systems to support safe, compliant, and efficient production.
Key Responsibilities
Perform preventive, predictive, and corrective maintenance on solid oral dosage equipment, including:
Blenders, granulators, mills.
Tablet presses and capsule fillers
Coating machines.
Packaging lines (bottle, blister, cartoners)
Troubleshoot mechanical, electrical, pneumatic, and automation issues to minimize downtime.
Support equipment installation, commissioning, qualification (IQ/OQ), and validation activities.
Maintain accurate maintenance records, work orders, and equipment logs in the CMMS system.
Ensure all maintenance activities comply with cGMP, safety, and regulatory requirements.
Collaborate with Production, Quality, and Engineering teams to resolve equipment-related issues.
Participate in root cause analysis (RCA) and implement corrective and preventive actions (CAPA).
Identify opportunities for equipment upgrades, reliability improvements, and process optimization.
Support audits, inspections, and documentation requests from QA and regulatory bodies.
Ensure spare parts inventory is maintained and managed effectively.
Qualifications
Bachelor’s degree in mechanical, Electrical, Industrial, or related Engineering field (or equivalent experience).
4+ years of maintenance experience in a
pharmaceutical oral solid dosage
manufacturing environment.
Strong understanding of cGMP, FDA, and safety regulations.
Hands-on experience with tablet compression, encapsulation, granulation, and coating equipment.
Ability to read mechanical drawings, electrical schematics, and equipment manuals.
Experience with CMMS systems and maintenance documentation.
Strong troubleshooting, analytical, and problem-solving skills.
Ability to work independently and in cross-functional teams.
Preferred Skills
Experience with automation systems (PLC, HMI, SCADA).
Knowledge of HVAC compressed air, and utility systems.
Familiarity with lean manufacturing and reliability engineering principles
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