- Merck & Co. (Rahway, NJ)
- …and documentation of all stages of cell culture process commercialization. Risk assessment, control strategies, process comparability reports, Process ... Mammalian Cell Culture, Manufacturing Scale-Up, Mentorship, Process Characterization, Process Control , Process Design, Process Optimization, Regulatory Submissions, Risk… more
- Merck & Co. (Rahway, NJ)
- …design and development, manufacturing process development, qualification, validation, and design control and risk management techniques to positively support and ... experts within the broader DD&T team (eg design verification, device risk management, human factors, technical integration, assembly automation, etc.), as well… more
- Merck & Co. (Rahway, NJ)
- …reports (SORs) to promote fast and efficient closure.As needed, safely perform High Risk Work involving hazardous energy control .Identify and follow through on ... opportunities to improve building flexibility, efficiency, compliance, and safety.Author lessons learnt and summary reports to capture knowledge gained.Mentor and help train rotational and new employees.This position's primary focus is executing batch… more
- Merck & Co. (Austin, TX)
- …enabling automation pipelines that support AI-driven defense and enterprise-scale risk reduction.Job Description:You'll be working in a forward-leaning engineering ... The systems you build will be foundational to how we scale AI, automate risk response, and reduce manual toil across the enterprise.As a Platform Engineer, you'll… more
- Merck & Co. (Rahway, NJ)
- …be expected to apply his/her knowledge of product development and design control principles to positively support and influence clinical and commercial combination ... apply regulatory / compliance requirements relative to design controls and risk management activities.Lead the preparation of materials for program presentations for… more
- Merck & Co. (Rahway, NJ)
- …such as site readiness, audits, inspections, and CAPAs. Support quality risk management activities as facilitator, project lead and/or quality subject matter ... Auditing, Interpersonal Relationships, Management Process, Manufacturing Processes, Manufacturing Quality Control , Process Improvements, Quality Assurance (QA), Quality Assurance Systems,… more
- Aequor (East Syracuse, NY)
- …and coordinating timely transfer of test methods with and to Quality Control laboratories is desired. Specific Knowledge, Skills, Abilities, etc. Strong written, ... deliverables within given timelines. Ability to problem solve and apply risk -based critical thinking in a technical environment. Demonstrated history of continuous… more
- Merck & Co. (Durham, NC)
- …goals through a risk -based approach (Safety Regulations, Quality Assurance, Risk Management, Deviation Management, Product Release, Change Control ).- Supply ... provide Operations input into Supply and Quality Agreements.- Launch Supply Risk Mitigation:-Ensure External Partner Site Readiness, Assist with Technology Transfer,… more
- Novo Nordisk Inc. (Durham, NC)
- …machine learning for anomaly detection and predictive maintenance, advanced control strategies for quality improvements, inventory management using predictive ... relevant areas Own self development & initiative to understand the site process control systems, data management systems, and differing data sources (PCS, MES, SAP,… more
- Merck & Co. (Rahway, NJ)
- …(MCAAS) primary purpose is to provide value-added independent and risk -based audit and assurance services.Position Overview / Function and ResponsibilityThe ... of the audits and assessments.Demonstrates knowledge of and techniques to assess risk and evaluate the effectiveness of internal controls in moderately complex… more
- Merck & Co. (Rahway, NJ)
- …expertise to optimize and fully characterize the enzyme manufacturing process control strategy across different scales.The successful candidate will play a pivotal ... candidate will provide scientific expertise by learning and utilizing Quality Risk Management methodologies and tools for statistical design of experiments. This… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …certification for new Manufacturing (process equipment & facility-support equipment) and Quality Control facilities as needed as well as the continued operation of ... with investigations Completes accurate and timely assessments associated with change control activities Ensures change control activities for systems are… more
- Merck & Co. (Rahway, NJ)
- …Identify and design improvement opportunities within the Support Model to reduce compliance risk and increase efficiency for the Support Team and End Users. Conduct ... as User Guidance and Standard Operating Procedures (SOP) and change control management is desirable.Good understanding of SDLC Documentation requirements and… more
- BioAgilytix (San Diego, CA)
- …of laboratory systems and softwareAuthors and reviews validation deliverables ( risk assessment, requirements specification, IQ/OQ/PQ, etc.) Contributes to the ... and revision of Computer System Validation procedures and policies (validations, change control , data integrity), following 21 CFR Part 11, Annex 11, GxP, and… more
- Merck & Co. (Durham, NC)
- …degree of accuracyStrong analytical and problem-solving skills.- Strong risk -based decision-making skills.A positive, collaborative, consensus building approach to ... Communication, Customer-Focused, Data Analysis, Financial Forecasting, Inventory Accuracy, Inventory Control Management, Logistics Management, Logistics Planning, Management Process, Material… more
- Merck & Co. (Rahway, NJ)
- …development and chemistryHigh-throughput experimentation, automation, and process control .Knowledge of microbial fermentationCell culture predictive modeling (omics ... Line Engineering, Clinical Judgment, Communication, Flux Analysis, Human Health Risk Assessment, Innovative Thinking, Interpersonal Relationships, Mammalian Cell Culture,… more
- Aequor (Thousand Oaks, CA)
- …and implement the NPI project plan(s), being accountable for NPI scope, schedule, risk management, and leading matrixed teams through influence to meet NPI project ... Filling operations Experience with various quality systems including change control , deviations, corrective and preventative actions, and/or validation practices… more
- Merck & Co. (Rahway, NJ)
- …desired results. Reviews and defends stage-gate deliverables for programs including risk assessment and mitigation plans and engages in corporate governance meetings ... Skills:Business, Business, Compliance Investigations, Confidentiality, Cross-Cultural Awareness, Detail-Oriented, Document Control Systems, Electronic Common Technical Document (eCTD), Ethical Compliance,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …cGMP manufacturing and project planning experience preferred.Provide technical expertise of Change Control process as well as oversight of the MES team to ensure ... in the evaluation of potential process changes for effectiveness, value, risk , and priority.Drive the implementation of MES enhancements that would provide… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in support of company objectives, operating model decision, mitigate decision risk , drive action plan development and ultimately improve commercial and clinical ... required. Comfort operating in a fast-paced, environment, with a quality control focus and a documentation orientation Innate intellectual curiosity, demonstrated… more
