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Ensure compliance with FDA, cGMP, GAMP 5, ALCOA+, and 21 CFR Part 11 requirements. * Collaborate with Automation, Engineering, IT, Manufacturing, and Quality teams during project execution. * Support ...

Oversee the maintenance of the SHINE licensing bases, including the Safety Analysis Reports for SHINE facilities licensed under 10 CFR Part 50 or 10 CFR Part 70 and the programs described therein.

Oversee the maintenance of the SHINE licensing bases, including the Safety Analysis Reports for SHINE facilities licensed under 10 CFR Part 50 or 10 CFR Part 70 and the programs described therein.

Oversee the maintenance of the SHINE licensing bases, including the Safety Analysis Reports for SHINE facilities licensed under 10 CFR Part 50 or 10 CFR Part 70 and the programs described therein.

Ensure compliance with FDA 21 CFR Part 820 / QMSR, ISO 13485, GMP requirements, and customer-specific quality requirements. * Support internal, customer, and regulatory audits. Project Management ...

Ensure compliance with FDA 21 CFR Part 820 / QMSR, ISO 13485, GMP requirements, and customer-specific quality requirements. Support internal, customer, and regulatory audits. Project Management ...

This role is critical in ensuring compliance with regulatory standards (FDA, ISO 13485, 21 CFR Part 820), working closely with engineering, QA, and manufacturing teams. Key Responsibilities:

... CFR 60-741.5(A), which prohibits discrimination against qualified individuals on the basis of disability.

This role ensures manufacturing processes are developed, validated, transferred, and maintained in compliance with FDA Quality System Regulation (21 CFR Part 820), ISO 13485, customer requirements ...

Adobe Acrobat, Word, Excel, PowerPoint Experience Preferred: · Experience in food manufacturing environment with exposure to 21 CFR 106, 21 CFR 107, 21 CFR 117, Lean manufacturing philosophy, and ...

Develop, maintain, and troubleshoot PLC programs using Rockwell Automation ControlLogix and CompactLogix platforms in compliance with cGMP and FDA 21 CFR Part 11 requirements * Design, program, and ...

Experience in regulated food manufacturing environment with exposure to 21 CFR 106, 21 CFR 107, 21 CFR 117, Lean manufacturing philosophy, and FSSC 22000/SQF regulations is preferred, but not ...

Interpret and apply requirements of 21 CFR Part 507 and related FDA guidance documents. * Monitor regulatory changes and communicate impacts to internal stakeholders. * Maintain regulatory ...

Develop, maintain, and troubleshoot PLC programs using Rockwell Automation ControlLogix and CompactLogix platforms in compliance with cGMP and FDA 21 CFR Part 11 requirements * Design, program, and ...

The Safety Engineer ensures compliance with OSHA Process Safety Management standards, OSHA 29 CFR requirements, and DOD 4145.26M, while driving a strong safety culture through training, auditing, and ...

Regulatory Strategy & Compliance Oversight · Ensures compliance with FDA regulations, including 21 CFR Part 117 (Preventive Controls for Human Food), food labeling requirements, and allergen control ...

Experience in regulated food manufacturing environment with exposure to 21 CFR 106, 21 CFR 107, 21 CFR 117, Lean manufacturing philosophy, and FSSC 22000/SQF regulations is preferred, but not ...

Oversee the maintenance of the SHINE licensing bases, including the Safety Analysis Reports for SHINE facilities licensed under 10 CFR Part 50 and the programs described therein. * Interface with ...

Oversee the maintenance of the SHINE licensing bases, including the Safety Analysis Reports for SHINE facilities licensed under 10 CFR Part 50 and the programs described therein. * Interface with ...

Lead or support engineering change packages (ECPs), including design reviews, configuration control, and as‑built documentation updates; ensure compliance with ASME NQA‑1, 10 CFR 50, and ...