Granules Pharmaceuticals, Inc.
Mechanical Engineer (Chantilly, VA)
Granules Pharmaceuticals, Inc., Chantilly, Virginia, United States, 22021
Description
Sr. Mechanical Engineer (Chantilly, VA) for Granules Pharmaceuticals Inc. The job duties include but are not limited to the following responsibilities and requirements. Responsibilities
Oversee, evaluate, maintain and calibrate equipment, and procedures used in the development and production of pharmaceutical products Ensure safety, quality, and purity requirements are met Ensure equipment is suitable for its intended use through the development and execution of qualification documentation to support the System Life Cycle, including facilities, utilities, equipment, and automation Ensure compliance by following government regulations including but not limited to FDA (21 CFR 210/211 and Part 11), EMA and company policies Develop and review SOPs, DQ, IQ, OQ and PQs, and Change controls for all process equipment Execute equipment/systems qualifications and validation protocols Provide coordination and support for all equipment/facility related change control, deviations, CAPAs, and Capital Projects Communicate cross-functionally and with customers, vendors, suppliers, contractors, and management on project related activities Coordinate with manufacturing, formulation development, packaging, and Quality Assurance personnel on a day-to-day basis Perform evaluation studies and validation of manufacturing equipment, utilities, and systems Lead team members while promoting a positive team environment Analyze existing equipment and recommend modifications for process optimization Supervise 2 Mechanical Technicians Requirements
Minimum Education & Experience: Must have a Bachelor degree in Mechanical Engineering or Industrial Engineering plus 3 years experience in a related role. As an alternative, an Associate’s Degree plus 2 years experience is acceptable. Required skills: IQ/OQ/PQ, CAPA, API, PLC, FDA regulations, cGMP/SOPs Job Location
Chantilly, VA Additional information
Submit résumé referencing job code SAM014 to HR, Granules Pharmaceuticals, Inc., 3701 Concorde Parkway, Chantilly, VA 20151 Seniority level: Mid-Senior level Employment type: Full-time Job function: Engineering and Information Technology Industries: Pharmaceutical Manufacturing
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Sr. Mechanical Engineer (Chantilly, VA) for Granules Pharmaceuticals Inc. The job duties include but are not limited to the following responsibilities and requirements. Responsibilities
Oversee, evaluate, maintain and calibrate equipment, and procedures used in the development and production of pharmaceutical products Ensure safety, quality, and purity requirements are met Ensure equipment is suitable for its intended use through the development and execution of qualification documentation to support the System Life Cycle, including facilities, utilities, equipment, and automation Ensure compliance by following government regulations including but not limited to FDA (21 CFR 210/211 and Part 11), EMA and company policies Develop and review SOPs, DQ, IQ, OQ and PQs, and Change controls for all process equipment Execute equipment/systems qualifications and validation protocols Provide coordination and support for all equipment/facility related change control, deviations, CAPAs, and Capital Projects Communicate cross-functionally and with customers, vendors, suppliers, contractors, and management on project related activities Coordinate with manufacturing, formulation development, packaging, and Quality Assurance personnel on a day-to-day basis Perform evaluation studies and validation of manufacturing equipment, utilities, and systems Lead team members while promoting a positive team environment Analyze existing equipment and recommend modifications for process optimization Supervise 2 Mechanical Technicians Requirements
Minimum Education & Experience: Must have a Bachelor degree in Mechanical Engineering or Industrial Engineering plus 3 years experience in a related role. As an alternative, an Associate’s Degree plus 2 years experience is acceptable. Required skills: IQ/OQ/PQ, CAPA, API, PLC, FDA regulations, cGMP/SOPs Job Location
Chantilly, VA Additional information
Submit résumé referencing job code SAM014 to HR, Granules Pharmaceuticals, Inc., 3701 Concorde Parkway, Chantilly, VA 20151 Seniority level: Mid-Senior level Employment type: Full-time Job function: Engineering and Information Technology Industries: Pharmaceutical Manufacturing
#J-18808-Ljbffr