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Description

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.

The Junior Engineer / Trainee Engineer of F&E is a team member overseeing the facilities operations in a Granules pharmaceutical facility. This role includes maintenance, repair and continuous improvement of HVAC, electrical, mechanical, critical utilities, and general upkeep of the facility. Planning/scheduling, contractor arrangements, successful or improving metrics, and GMP documentation of all activities are necessary aspects of this role. 

Requirements

• Manage the design, planning, construction, and maintenance of building, equipment, and other facilities.
• Maintaining all necessary documents as per Food and Drug Administration (FDA) standards.
• Developing, executing and reviewing the IQ/OQ/PQ protocol of in-process machine, equipment and utilities.
• Worked with pharmaceuticals manufacturing machine/equipment and performed installation, qualification and upgrades of machines as required.
• Troubleshoot very large-scale integrated circuit used in pharmaceuticals manufacturing equipment/machines.
• Assisting, coordinating and supervise equipment commissioning, installation, and validations.
• Performing engineering management of any electrical/facility upgrades and/or expansion.
• Analyzing and reacting to project estimates and facilitating capacity and process constraints.
• Managing costs to justify various tools equipment, processes or method improvements for cost reduction, quality improvements, innovation, safety, and improved electrical efficiency.
• Responsible for managing and supervising a general mechanic and an electrical engineer.
• Coordinate and support warehouse, production, and laboratory team on facility related issues.
• Maintain execute scheduled preventative maintenance and calibration.
• Perform all EHS related activities including personnel training on safety procedures on the production floor and overall site.
• Perform risk management activities such as corrective and preventive action (CAPA), failure mode effects analysis (FMEA), design failure mode effects analysis (DFMEA)
• Troubleshoot process and quality defects in area of responsibility. 
• Review production, quality control and maintenance reports and statistics to plan and modify maintenance activities. 

Management Responsibility 

Works under minimal supervision

Reports to

Manager of Facilities & Engineering

Internal/External Contacts

Vendors/contractors

Knowledge & Skills 

• Qualifying experience must include experience with working on very large-scale integrated circuits and performing installations, qualifications, and upgrades of machines highly preferred 

Experience & Education

• Minimum of a Bachelor/Master's degree Electrical or Mechanical Engineering, Science, or related field.
• 0-2 years of related experience. Training will be provided.

Physical Requirements/Working Environment

• Hours are flexible depending on business needs based on production/R&D process workflow and may require working earlier in the morning, evening hours, or during the weekend. Ability to lift up to 50 pounds

Disclaimer

The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job.