Company: Granules Pharmaceuticals
Posted on: April 16, 2019
Maintain the facility and equipment in a good operating condition
as per Production and FDA requirements.
- Manage the design, planning, construction, and maintenance of
building, utilities, equipment and other facilities
- Thorough knowledge of Good Manufacturing Practices (GMP), Good
Engineering Practices (GEP) and some knowledge of Good Lab
- Implement and manage all security system pertaining to the
building to secure the site and to adhere DEA compliance
- Coordinate and maintain all personel in the production,
warehouse and maintenance records on safety gear and safety
- Perform all EHS related activiites including personnel training
on safety procedures in the production floor and overall site
solvent handling at warehouse, production and laboratory.
- Knowledge of handling hazardous chemicals, Virginia DEQ
environment air permitting regulations waste water treatment
system, Environmental Protection Agency (EPA) regulations, fire
codes, building codes, fire wet sprinkler system, building alarm
system, local and state government regulations relating to the
- Maintain all necessary documents as per Food and Drug
Administration (FDA) standards.
- Write, execute and review installation qualifiaciton (IQ) ,
operational qualfication (OQ) and performance qualification(PQ)
protocol of equipment, facility and utilities.
- Write, execute and review standard operation procedures (SOP),
perform investigation into quality incidents, initiate corrective
and preventative actions (CAPA) and check for CAPA
- Analyze trends in data in order to provide accurate
descriptions, identify root causes, and/or indenity solutions or
- Initiate, maintain and review work order procedure system
related to manufactuirng equipment and utilities.
- Comprehensive hands on knowledge of pharmaceutical
manufacturing processes and ability to troubleshoot equipment and
utilities related to facility operation.
- Managing budget on facility expanision and maintenance
- Troubleshoot large scale integrated circuit motors, variable
frequency drives, programming login, controllers, relays starters,
contractors, etc., used in pharmaceutical manufacturing
- Assisting, coordinating and supervise equipment commissioning,
qualification and validation activities.
- Coordinate HEPA filter certification, particle count testing,
microbial testing, air flow testing, room pressurization techniques
and other related tests to comply with Class 100,000/ISO 8 GMP
- Perform engineering managment of any electrical facility
updgrades and or expansion
- Manage and coordinate the facility and equipment work either
through internal resources or with outside contractors
- Enforce strict safety procedures on process, laboratory and
- Analyzing and reacting to project estimates and faciliting
capacity and process constraints.
- Managing costs to justify various tools, equipment, processes
or method improvements for cost reduction, qulaity improvements,
innovaiton, safety and improved process efficiency.
- Cooridnate and support warehouse production and laboratory team
on facility related issues.
- Periodically train facility mechanics
- Maintain and execute the scheduled preventative maintenance and
calibration program activities
- Execute and maintian PM and Calibration Prgoram using
computerized maintenance management system
- Maintain inventory of equipment spart parts used in the
production equipment and utilities.
Knowledge & Skills:
Qualifying experience must include working and troubleshoot larde
scale inegrated circuits, motors
Experience & Education:
Position requires a minimun of a Bachelor/Master's degree or
foreign equivalent in Electrical or Mechanical Engineering. Scient
or realted field plus, 3-7 years of experience in the position
offered or in any position/title providing experience with working
on large scale integrated circuits and performing installations,
qualificaitons and upgrades of machines. In leiu of Master's degree
and 2 years of expereince, employer will accept Bachelor's degree
or foreign equivalent in Elctrical or Mechanical Engineering,
Science or related field plus 5 years of progressive work
experience with working on large scale intergated circuits and
performing installations, qualification and upgrades of
Keywords: Granules Pharmaceuticals, Chantilly , Mechanical Engineer, Engineering , Chantilly, Virginia
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