#x 9; Optimizing batch manufacturing processes, ensuring compliance with regulatory standards, and enhancing data integrity. Collaborate with cross-functional teams, including manufacturing, quality assurance, and regulatory affairs, to gather information and resolve discrepancies Responsible for the design, implementation, and maintenance of the Electronic Batch Records (e. BR). Create, manage, and maintain electronic batch records, including recipe management, process steps, electronic signatu... more details
Kelly® Engineering is seeking a MES Specialist (Manufacturing Execution System) for an excellent direct hire position with an innovative company that holds a Great Places to Work certification in Parsippany, NJ. This position offers a salary up to $125K based on experience, dynamic growth potential and a positive team environment. If you are passionate about shaping the world we live in and are ready to reengineer your future, trust the experts at hiring experts.
MES Specialist Responsibilities:
Optimizing batch manufacturing processes, ensuring compliance with regulatory standards, and enhancing data integrity.
Collaborate with cross-functional teams, including manufacturing, quality assurance, and regulatory affairs, to gather information and resolve discrepancies
Responsible for the design, implementation, and maintenance of the Electronic Batch Records (eBR).
Create, manage, and maintain electronic batch records, including recipe management, process steps, electronic signatures, and data capture
Plan and execute validation tests (IQ, OQ, PQ) for eBR systems to demonstrate their compliance with regulatory requirements.
Oversee -User -Acceptance Testing of MES recipes to ensure business requirements are achieved
Ensure that all batch records and related documentation adhere to Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
Initiate and process change controls related to batch records, ensuring that any deviations, revisions, or updates are properly documented and approved.
MES Specialist Requirements:
Bachelor’s Degree in Engineering, Science or IT
Previous experience in Pharmaceutical manufacturing
Proficiency in MES eBR software platform Rockwell Automation PharmaSuite.
Strong understanding of regulatory requirements with batch processes, including FDA regulations (e.g., 21 CFR Part 11).
Familiarity with Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) to ensure compliance.
What happens next: Once you apply, you’ll proceed to next steps if your skills and experience look like a good fit. But don’t worry – even if this position doesn’t work out, you’re still in the Kelly Engineering network. That means our team of expert engineering recruiters will have access to your profile, making your opportunities limitless.
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