- 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
- Assisting, coordinating and supervise equipment commissioning, installation, and validations.
- Performing engineering management of any
- 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.
- Qualifying experience must include experience with working on very large-scale integrated circuits and performing installations, qualifications, and upgrades of machines.
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Facilities Engineer Pharmaceutical Manufacturing Facility - Chantilly, United States - Granules
Description
Job DescriptionJob Description Description:
Job Summary
The Facilities Engineer 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.
Principle Accountabilities
JOB DUTIES & RESPONSIBILITIES
upgrades and/or expansion.
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
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 poundsTravel
n/a
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
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.
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Facilities Engineer Pharmaceutical Manufacturing Facility professionals in Chantilly
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SHAFIQULLAH OMAR
Project Manager