Senior Mechanical Engineer
3 days ago
**Job Title:** Senior Mechanical Engineer
We are seeking a highly skilled Sr. Mechanical Engineer to join our team at Granules Pharmaceuticals Inc in Chantilly, VA.
Salary: $85,000 - $110,000 per year (depending on experience)
Job DescriptionAs a Sr. Mechanical Engineer, you will be responsible for overseeing, evaluating, maintaining and calibrating equipment and procedures used in the development and production of pharmaceutical products. This includes ensuring safety, quality and purity requirements are met, as well as ensuring equipment is suitable for its intended use through the development and execution of qualification documentation to support the System Life Cycle.
You will also be responsible for ensuring compliance with government regulations, including but not limited to FDA (21 CFR 210/211 and Part 11), EMA and company policies. Additionally, you will develop and review SOPs, DQ, IQ, OQ and PQs, and Change controls for all process equipment, execute equipment/systems qualifications and validation protocols, and provide coordination and support for all equipment/facility related change control, deviations, CAPAs, and Capital Projects.
Requirements:
- Bachelor's degree in Mechanical Engineering or Industrial Engineering plus 3 years experience in job offered or as Sr. Technical Service Engineer.
- Require skills and working knowledge of IQ/OQ/PQ, CAPA, API, PLC, FDA regulations, cGMP/SOPs.
Location: Chantilly, VA. Please submit your resume referencing job code SAM014 to HR, Granules Pharmaceuticals, Inc.
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