- Catalent (Manassas, VA)
- …and cross-functional areas in regulatory requirements. The Associate Director, Regulatory Affairs will review change control for potential impact on ... Associate Director, Regulatory Affairs Position Summary: Catalent is a global,...as assigned The Candidate: Bachelor's degree in Chemistry, Biology, Engineering or equivalent, required 8 + years within the… more
- Merck & Co. (Durham, NC)
- …produce life-saving medicines and vaccines, including our HPV vaccines. - The Senior Engineering Specialist will troubleshoot and maintain process and process ... Control System (DCS), Programmable Logic Controllers (PLC), robotics) Process Utility Systems (eg Clean-In-Place (CIP) Systems, Water for Injection (WFI),… more
- Merck & Co. (Durham, NC)
- …edit validation documents to support regulatory filingsSupport Change Control documentation for complex process , validation, analytical, equipment, ... media preparation, vaccine filling, lyophilization, and capping/inspection unit operations, including engineering runs and process validation lots of vaccine… more
- Merck & Co. (Durham, NC)
- Job DescriptionThe Mechanical Services Engineer ( Process ) will troubleshoot and maintain process and process support equipment utilized in a new drug ... written documentation of activities. Responsible for SAP transactions and change control activities including spare part lists and Preventative Maintenance (PMs)… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …and PLC'sExperience with plant start-up, commissioning, and qualification and process improvement.Education Requirements Bachelor's Engineering degree required; ... Position Summary The Engineering Director is directly responsible for leading the...and commissioning of facility systems, as well as all process and laboratory equipment. Direction and leadership to the… more
- Fidelity TalentSource LLC (Westlake, TX)
- …web-based applicationsGuide in development best practices for the full software creation process , including coding standards, code reviews, source control , build ... development, technical mentoring, cross team collaboration with a diverse and co-located engineering team, and the ability to visualize customer issues as drivers… more
- Fidelity TalentSource LLC (Durham, NC)
- …Supervises the work of programmers, technologists and technicians and other engineering and scientific personnel. Develops and directs software system testing and ... foreign education equivalent) in Applied Computer Science, Computer Science, Engineering , Information Technology, Information Systems, Information Management, Business Administration,… more
- Fidelity TalentSource LLC (Jersey City, NJ)
- Job Description:We are currently sourcing for a Director, Trading Engineering for Crypto Trading to work in Jersey City, New Jersey. The Role The Director, Trading ... Engineering will be working in development and delivery of...software with a high degree of automationProficient with version control systems and can handle development for multiple releases… more
- Careerbuilder-US (San Marcos, CA)
- …Duties and Responsibilities: * Support production and quality team in quality and process control for prototype, NPI, and sustaining products through quality ... departments, suppliers, and customers on technical and quality matters for process improvement. Responsible for maintenance, improvement, and compliance to the… more
- Merck & Co. (Rahway, NJ)
- …expected to apply his/her knowledge of product design and development; manufacturing process development, qualification, and validation; and, design control and ... with deep working knowledge of device and/or biologic/drug product and process development including regulatory submission and approval processes.Has broad… more
- Ecovyst (Carson, CA)
- …to analyze process and drive improvements. Author RCFAs as needed. Improve process tuning and control schemes. Maintain, update, and improve site control ... to comprehend equipment, P&ID, loop, etc. drawings.Working knowledge of chemical engineering principles including process controls Ability to multi-task and… more
- Merck & Co. (Durham, NC)
- Job Description GENERAL SUMMARY The Engineering , Maintenance and Site Services (EMSS) organization continuously improve the reliability of the Durham Site operations ... an Associate Director opening for the Teknika maintenance and Engineering team. The selected candidate will manage the ...facility. The Teknika Facility handles and End to End process and part of the main equipment includes all… more
- Stratas Foods (Lake Park, GA)
- …meeting our business goals. Job Description The Plant Engineer will provide engineering support for the plant, to include project implementation, production and ... ensure all safety and quality goals are achieved. Responsibilities: Project and Process management, purchasing, and supervision of contractors for all projects to… more
- Russell Tobin & Associates (Dublin, OH)
- …manage projects from concept to delivery, and will have a civil engineering background that includes local and state permitting, and stormwater design along ... work assignments to internal project teams and subcontractors Interact with regulatory agencies knowing what information to provide, when, and with appropriate… more
- Reynolds Consumer Products Inc. (Louisville, KY)
- …resources.Create and/or assist in the development of technical documents to assist engineering , maintenance, and operations.Support process control and ... experience in a manufacturing environment.Demonstrated high level competencies of engineering concepts, process control and instrumentation, and… more
- Fidelity TalentSource LLC (Westlake, TX)
- …performing Risk and Control Testing building and testing the internal control testing methodology for regulatory based testing, using Archer GRC; creating, ... sound recommendations for improvement and/or mitigation -- in alignment with regulatory guidelines. Modernizes risk management and tests using data investigation.… more
- Catalent (Harman, WV)
- …Quality Management Systems (QMS) to ensure the site is compliant with regulatory , Corporate, and customer requirements. They are responsible for establishing and ... of Quality-Maryland is responsible for Quality, Validation and Quality Control and is the most responsible person for batch...as the site's primary contact (with both customers and regulatory agencies) for the site Quality Unit. Develop and… more
- Merck & Co. (Durham, NC)
- …ManagerProvides technical specifications and information to Quality, Manufacturing, Process -Project EngineersAids in the development of SOPs, engineering ... Refrigeration is accountable for providing maintenance and troubleshooting supporting vaccine process equipment operations. Key Functions Work Independently and as a… more
- Merck & Co. (Durham, NC)
- …written documentation of activities. Responsible for SAP transactions and change control activities including spare part lists and Preventative Maintenance (PMs) ... and other groups as required.- Responsible for supporting: - Process Equipment (eg tanks/bioreactors, filtration skids, chromatography columns)-Support Equipment (eg… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …discharge compliance. Develops and improves site policies, prepares and submits regulatory reports, independently track recurring regulatory reports & permitting ... referral: 0 Essential Functions Environmental & Waste Management Prepare and submit regulatory reports and filings, to include: air emissions, Tier II, Toxics… more
