Senior Mechanical Engineer
8 hours ago
We are seeking a highly skilled Senior Mechanical Engineer to join our team at Granules Pharmaceuticals Inc. in Chantilly, VA.
Key Responsibilities- Oversee the development and production of pharmaceutical products, ensuring safety, quality, and purity requirements are met.
- Ensure equipment is suitable for its intended use through qualification documentation and system life cycle management.
- Develop and review SOPs, DQs, IQs, OQs, and PQs, as well as change controls for all process equipment.
- Execute equipment/systems qualifications and validation protocols, and support vendor qualification functions.
- Provide coordination and support for equipment/facility-related change control, deviations, CAPAs, and capital projects.
- Communicate cross-functionally with customers, vendors, suppliers, contractors, and management on project-related activities.
- Co-ordinate with manufacturing, formulation development, packaging, and quality assurance personnel on a daily 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.
- Must have a Bachelor's degree in Mechanical Engineering or Industrial Engineering, plus 3 years of experience in the offered job or as a Sr. Technical Service Engineer.
- Require skills and working knowledge of IQ/OQ/PQ, CAPA, API, PLC, FDA regulations, and cGMP/SOPs.
Job Location: Chantilly, VA. If you are interested in this opportunity, please submit your resume referencing job code SAM014 to HR, Granules Pharmaceuticals, Inc., 3701 Concorde Parkway, Chantilly, VA 20151.
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