Granules Pharmaceuticals Inc.
Sr. Mechanical Engineer (Chantilly, VA)
Granules Pharmaceuticals Inc., Chantilly, Virginia, United States, 22021
Description
As a Sr. Mechanical Engineer (Chantilly, VA) for Granules Pharmaceuticals Inc, the job duties include but not limited to:
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 SOP, DQ, IQ, OQ and PQs, and Change controls for all process equipment;
Execute equipment/systems qualifications and validation protocols;
Support vendors qualification functions;;
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;
Co-ordinates with manufacturing, formulation development, packaging, and Quality assurance personnel on an everyday 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 recommends 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 job offered or as Sr. Technical Service Engineer. As an alternative to Bachelor’s degree, Associate’s Degree plus 2 years experience is acceptable.
Require skills and working knowledge of IQ/OQ/PQ, CAPA, API, PLC, FDA regulations, cGMP/ SOPs.
Job Location Chantilly, VA. Submit résumé referencing job code SAM014 to HR, Granules Pharmaceuticals, Inc., 3701 Concorde Parkway, Chantilly, VA 20151.
#J-18808-Ljbffr
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 SOP, DQ, IQ, OQ and PQs, and Change controls for all process equipment;
Execute equipment/systems qualifications and validation protocols;
Support vendors qualification functions;;
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;
Co-ordinates with manufacturing, formulation development, packaging, and Quality assurance personnel on an everyday 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 recommends 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 job offered or as Sr. Technical Service Engineer. As an alternative to Bachelor’s degree, Associate’s Degree plus 2 years experience is acceptable.
Require skills and working knowledge of IQ/OQ/PQ, CAPA, API, PLC, FDA regulations, cGMP/ SOPs.
Job Location Chantilly, VA. Submit résumé referencing job code SAM014 to HR, Granules Pharmaceuticals, Inc., 3701 Concorde Parkway, Chantilly, VA 20151.
#J-18808-Ljbffr