- Novo Nordisk Inc. (West Lebanon, IN)
- …Ability to demonstrate broad understanding of Concepts of Validation Change control processes Root cause analysis techniques and cGMP documentation practices ... validation protocol execution (IQ, OQ, PQ & PV), data analysis and final report preparation for utilities, equipment and...Actively participate on cross functional teams to determine the root cause and corrective actions for problems… more
- Merck & Co. (Rahway, NJ)
- …batch execution, building housekeeping, and consumable inventory. - Provide input for incident root cause analysis , reporting, and action items. - Facilitate ... Assurance, Process Technologies, Production Efficiencies, Production Scheduling, Raw Material Sampling, Root Cause Analysis Training, Safety Protocols, Shift… more
- Merck & Co. (Durham, NC)
- …Osmosis systems, WFI generation and distribution.Experience with formal problem-solving techniques, such as root cause analysis (RCA), failure mode effects ... and scope of the investigation to identify the appropriate root cause , implement corrective actions, complete trending analysis , and determine product… more
- Novo Nordisk Inc. (Durham, NC)
- …Support &/or lead the closure of investigations per approved timeframes using root cause analysis & systematic problem-solving techniques Participate ... preferred At least one (1) year of demonstrated experience using root - cause analysis techniques to solve problems preferred Organization/Planning:… more
- Eisai, Inc (Exton, PA)
- …GxP Systems as assigned.Creates and updates deviation management processes (including investigations and root cause analysis ) and procedures for GxP systems ... through insightful solutions that address complex issues. Ability to dissect root cause of issues creating the best solution for Eisai considering quality,… more
- Merck & Co. (Rahway, NJ)
- …Management (PLM), Product Risk Management, Quality Management Systems (QMS), Risk Management, Root Cause Analysis (RCA) {+ 2 more}-Preferred Skills:Job ... or in biotech organizations Five plus years in design control, risk analysis and change control management for medical device or combination products- Demonstrated… more
- Novo Nordisk Inc. (Durham, NC)
- …methods (hypothesis testing, sampling, trending, etc.) a plus Expert in utilizing appropriate root - cause analysis tools & techniques a plus Experience with ... of quality documentation required Excellent troubleshooting skills with ability to identify root cause of problem required Demonstrated knowledge of critical… more
- Novo Nordisk Inc. (Durham, NC)
- …well as learning new systems Use Systematic Problem Solving (SPS) tools to establish Root Cause Analysis & resolve equipment issues Suggest practical changes ... or improvements to equipment & department work practices Collaborate with Responsible Engineers & Manufacturing personnel to troubleshoot equipment problems Other accountabilities, as assigned Physical Requirements Moves equipment &/or supplies weighing up to… more
- Aequor (Thousand Oaks, CA)
- …process change control requests per established SOP and processes. 6) Lead technical root cause analysis , incident investigations, and troubleshooting on ... process control issues related to mechanical, electrical, instrumentation and control systems. 7) Support new product introductions or new technology introductions by performing engineering assessments, implementing automation system configuration changes and… more
- Repligen (Waltham, MA)
- …for future implementation Implementation of corrective actions to solve problems based on root cause analysis Develop and own Process Improvement ... projects.Qualifications Engineering degree or equivalent required 5-7+ years of engineering experience in a manufacturing or product development environment Demonstrated track record of successful project execution Excellent presentation, verbal, and written… more
- Aequor (Athens, GA)
- …a timely manner; maintenance of technical data and support documentation Participate in root cause analysis and implement corrective and preventative actions ... to address problems; escalation of production flow disturbances Demonstrate a visible and tangible commitment to EHS (Environment, Health, and Safety) programs and initiatives Assessment of individual performance in regard to the continuous improvement (AAI)… more
- Merck & Co. (Durham, NC)
- …Management, Microsoft Word, Pharmaceutical Processing, Regulatory Compliance, Reliability Management, Root Cause Analysis (RCA), Strategic Thinking, ... Resolution, Deviation Investigations, Equipment Troubleshooting, Failure Mode and Effects Analysis FMEA, GMP Compliance, Identifying Customer Needs, Interpersonal Relationships,… more
- Merck & Co. (Lower Gwynedd, PA)
- …compliance requirements relative to their role.A problem solver/troubleshooter, skilled in Root Cause Analysis (RCA).#eligibleforerpCurrent Employees apply ... HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only:Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …minimal direction Ability to investigate and write up Deviation events utilizing Root Cause Analysis Incorporate pre-planned process improvements and ... Manufacturing for the coordination of process/equipment improvements and data trending/ analysis Review/approval of completed process documentation Ability to train… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …equipment troubleshooting and direct support to manufacturing teams, conduct deviation investigations, root cause analysis , validations for new equipment ... installs, and other tasks helping our manufacturing operations succeed day to day. This role will work closely with different functional groups accross the site for projects including: Manufacturing, MSAT, QA, and other engineering teams. This is an onsite… more
- Aequor (Swiftwater, MN)
- …members on comments. Skills: Technical writing abilities and good time management. Strong root cause analysis skills with experience regarding quality ... standards. Be able to establish working relationships with other support and production areas in order to gather all the necessary information required. Must be proficient in Veeva Vault with a working knowledge of templates, workflows and approval process.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …but not limited to Non-conformance Investigations, Out of Tolerances (OOTs), Change Controls, Root Cause Analysis and FMEA's.Ensures regulatory and job ... training remains current by promptly completing required training.Complies with all company and/or site policies and procedures.Demonstrates willingness to learn new skills as required.Available for other duties as required.Ensures site compliance with all… more
- Novo Nordisk Inc. (Durham, NC)
- …following systems: Instrument & Electrical, Mechanical, Control/SCADA/PLCs, Process Improvement Methodologies, Root Cause Analysis (RCA), & Reliability ... Centered Maintenance (RCM) preferred. Proven expertise in planning/organization/execution of maintenance activities, following up on results, & revising the work plan for complex problems being resolved by cross functional teams preferred. We commit to an… more
- Novo Nordisk Inc. (Boulder, CO)
- …actions Investigate unexpected or aberrant results during production to provide suitable root cause investigation analysis Support the technology transfer ... of manufacturing processes between Manufacturing Facilities Responsible for routine communication to all levels of the organization on manufacturing activity Support equipment calibration and maintenance programs Provides training, technical mentorship,… more
- Raytheon (Andover, MA)
- …will support programs and their mission of performing electrical component evaluations and root cause failure analysis . This position requires the knowledge ... that create a safer, more secure world. The Electrical Analysis - Northeast section of the Materials & Process...and understanding of electrical schematics, circuit analysis , digital processing, RF analysis ,… more
