- Exela Pharma Sciences, LLC (Lenoir, NC)
- …plant processesDevelop and maintain electrical and control schematics while ensuring compliance with safety and regulatory standardsProvide technical support for ... Position Summary:The Senior Controls Engineer will be responsible for installing, modifying, and...ICH. Understand 21 CFR Part 11, cGAMP, and other regulatory guidance associated with computer / automation based systemsAbility… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking MES Engineer as part of the Manufacturing Excellence team based in Raritan, NJ. Role ... OverviewThe MES Engineer will be part of Manufacturing Excellence team reporting...the Site Readiness of MES for FDA and/or Other Regulatory Audits / Inspections.This individual is responsible for the… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …plant processesDevelop and maintain electrical and control schematics while ensuring compliance with safety and regulatory standardsProvide technical support for ... Position Summary:Controls Engineer is responsible for installing, modifying, and servicing process control systems throughout the facility as well as providing… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position Summary:The Engineer , Network Automation will be responsible for installing, maintaining, and troubleshooting the networking systems for automated utility, ... to perform complex assessments for computer systems against current industry compliance requirementsAbility to understand and configure network switches using NAT… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- As a Sr Utilities Engineer (Clean Utilities), you will provide cross-functional support to operations, maintenance, quality and project teams for site GMP utilities. ... activities during project life cycle.You will lead or support overall compliance requirements for the Utilities areas, including SOPs, change control, quality… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …to ensure they operate as per the design intent and meet regulatory standards.Collaborate with mechanical engineers and contractors to ensure HVAC equipment is ... performance.Conduct routine system audits to ensure optimal performance and compliance with industry standards and regulations.Provide training to operations and… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …work, general instructions on new assignments Knowledge of Automation, GMPs, Compliance , and Regulatory requirements is essential Excellent communication skills ... our commercial pharmaceutical bioproduction plant. Relationships Reports to: Lead Engineer Number of subordinates with direct/indirect referral: None Essential… more
- Novo Nordisk Inc. (Durham, NC)
- …process control systems to meet current & projected customer, business & regulatory requirements through the following activities: People Focus, Equipment Focus & ... of Systematic Problem Solving, process improvement, & project management Operate within compliance with a Quality Mindset that focuses on risk management &… more
- Merck & Co. (Durham, NC)
- …work environment with optimized product quality and manufacturing processes and regulatory compliance . GENERAL PROFILE Provides leadership and direction through ... plans and contributes to the development of group strategiesPriorities based on compliance , departmental budget and profit plan to address resource and operational… more
- Tris Pharma (Monmouth Junction, NJ)
- …incumbent uses systems thinking and a holistic systems-based approach to drive compliance and assess operational needs and activities in to accurately, effectively, ... Continued Process Improvements (CPIs), Product Quality Complaints (PQC) documentation, compliance efforts, quality operations, etc. Responsibilities:Assures compliance … more
