Facilities Engineer Pharmaceutical Manufacturing - Granules Pharmaceuticals Inc.
Chantilly, VA 20151
About the Job
Granules Pharmaceuticals Inc. is a subsidiary of Granules India LTD. It is a vertically integrated pharmaceutical company, headquartered in Hyderabad, India, with a location in Chantilly, VA. We manufacture dosage forms with specific release capabilities like 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, all supported by their New API business.
Job Summary
We are seeking for a Facilities Engineer to become a team member of our organization with the responsibility to oversee 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.
Principle Accountabilities
JOB DUTIES & RESPONSIBILITIES
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.
OTHER or ADDITIONAL RESPONSIBILITIES
Perform other job-related duties as assigned at the discretion of management.
Management Responsibility
Works under minimal supervision
Reports to
Director, Facilities & Engineering
Internal/External Contacts
Vendors/contractors
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.
Requirements
Knowledge & Skills
Qualifying experience must include experience with working on very large-scale integrated circuits and performing installations, qualifications, and upgrades of machines.
Experience & Education
A minimum of a Bachelor/Master"s degree or foreign equivalent in Electrical or Mechanical Engineering, Science, or related field
At least two years of experience in the position offered or in any position/title providing experience with working on very large-scale integrated circuits and performing installations, qualifications, and upgrades of machines.
Employment Type: Full-Time
Job Summary
We are seeking for a Facilities Engineer to become a team member of our organization with the responsibility to oversee 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.
Principle Accountabilities
JOB DUTIES & RESPONSIBILITIES
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.
OTHER or ADDITIONAL RESPONSIBILITIES
Perform other job-related duties as assigned at the discretion of management.
Management Responsibility
Works under minimal supervision
Reports to
Director, Facilities & Engineering
Internal/External Contacts
Vendors/contractors
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.
Requirements
Knowledge & Skills
Qualifying experience must include experience with working on very large-scale integrated circuits and performing installations, qualifications, and upgrades of machines.
Experience & Education
A minimum of a Bachelor/Master"s degree or foreign equivalent in Electrical or Mechanical Engineering, Science, or related field
At least two years of experience in the position offered or in any position/title providing experience with working on very large-scale integrated circuits and performing installations, qualifications, and upgrades of machines.
Employment Type: Full-Time
Source : Granules Pharmaceuticals Inc.