- Merck & Co. (Rahway, NJ)
- …& Controls ( CMC) , Pre-approval Pharm will bring scientific and regulatory expertise, innovative approaches, and strong industry and FDA connections to our ... company. They will lead a team of CMC professionals, ensuring rigorous CMC regulatory strategy and delivery of high-quality submissions for products that may include… more
- Merck & Co. (Rahway, NJ)
- …Mechanical Systems, Operational Excellence, Process Control , Process Improvement Projects, Protein Purifications, Regulatory Compliance, Statistical ... fields.- - Requirements: - Working knowledge of aseptic techniques and fermentation process control strategies for batch and fed-batch processes.- Experience… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionDir, Engineering - Director, Assembly and Packaging Platform Technical LeadershipReporting into the Executive Director Packaging Technical Operations ... development and technology teams, supply chain, operations, quality, analytical, regulatory , and project leaders. The successful candidate will demonstrate ownership… more
- Merck & Co. (Rahway, NJ)
- …Compliance Packaging, Cross-Functional Teamwork, Detail-Oriented, Deviation Management, Engineering Standards, Good Manufacturing Practices (GMP), Management ... Process , Manufacturing Scale-Up, Mentorship, Packaging Engineering , Process Optimization, Risk Management, Root Cause Analysis (RCA), Social Collaboration,… more
- Merck & Co. (Rahway, NJ)
- …- Required Skills: Combination Products, Compliance Packaging, Deviation Management, Engineering Standards, ISO Standard, Management Process , Mechanical ... Job DescriptionThe Associate Director, Engineering , Packaging Commercialization will lead packaging development for...s are robust , packaging processes are efficient, and control strategies are integrated with both upstream and downstream… more
- Novo Nordisk Inc. (Durham, NC)
- … regulatory requirements through the following activities: People Focus, Process Focus, Equipment Focus & Standards "Gatekeeper". Relationships Reports to ... related field from an accredited university required with one (1) year of engineering experience in maintenance, design, process improvement, or Six Sigma Green… more
- Merck & Co. (Millsboro, DE)
- …SOPs, Quality Notifications and technical documentation; collaborate cross-functionally with QA, Regulatory Affairs, EHS, Engineering , BTS, ATS and HR.Direct ... Practices (GMP), Lean Six Sigma Process Improvement, Management Process , Manufacturing Quality Control , Motivating People, Packaging Processes, People… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the platform process description and collaborate to the global change control process and global investigations.Maintain global program project portfolio and ... platform changes/improvements in a global manufacturing network and drive change management process from inception through regulatory approval to global site… more
- Merck & Co. (Rahway, NJ)
- …assessment, control strategies, process comparability reports, Process performance qualification, and/or regulatory submissions.CMC RA: Experience ... Engineering Standards, Estimation and Planning, Maintenance Supervision, Management Process , Manufacturing Quality Control , Manufacturing Scale-Up, Manufacturing… more
- BioAgilytix (Durham, NC)
- …that boost lab productivity and keep BioAgilytix ahead of regulatory requirements.Key ResponsibilitiesData Governance & Quality Standards:Develop a foundational data ... governance framework, with hands-on responsibility for data quality, access control , and compliance protocols.Define standards, build quality assurance processes,… more
- Merck & Co. (Rahway, NJ)
- …Compliance Packaging, Cross-Functional Teamwork, Detail-Oriented, Deviation Management, Engineering Standards, Good Manufacturing Practices (GMP), Management ... Process , Manufacturing Scale-Up, Mentorship, Packaging Engineering , Process Optimization, Risk Management, Root Cause Analysis (RCA), Social Collaboration,… more
- Merck & Co. (Durham, NC)
- …is a member of the Focus Factory Automation team responsible for the assigned process control systems in support of manufacturing operations located in Durham, ... an aseptic manufacturing facility.- Responsible for problem resolution, implementation of process control , data collection techniques, and troubleshooting in… more
- Merck & Co. (Durham, NC)
- …of supply for registered materials or managing a portfolio of complex process changes with regulatory impact Responsibilities Business Case Development ... Management - Supply Transitioning Defining key business requirements (validation, regulatory filing, inventory builds, and creating inventory transition plans to… more
- Merck & Co. (Rahway, NJ)
- …Conflict Resolution, Cross-Functional Teamwork, Customer-Focused, Design Control Process , Ergonomics Consulting, Human Factor Engineering , Human Resource ... Staff, Negotiation, Neuropsychology, Patient Safety, Post Marketing Surveillance, Prioritization, Process Engineering , Product Lifecycle, Product Lifecycle Management… more
- Aequor (Thousand Oaks, CA)
- …solutions to meet those needs Experience with combination products and device regulatory requirements and medical device development and engineering Preferred ... per week. The ideal candidate is a Data Scientist with a strong engineering background, preferably in Mechanical, Biomedical, or Chemical Engineering , with… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the Site Strategic Initiatives team. This role will specialize in manufacturing process optimization and provide dedicated engineering expertise related to new ... This individual's primary responsibility will be support of manufacturing process optimization through process modelling, new technology integration,… more
- Merck & Co. (Millsboro, DE)
- …skills.Proficiency with pharmaceutical industry technical business processes:- change control , deviation management, technical protocols/reports, and regulatory ... Animal Health Large Molecule strategy team, regional operations team and engineering teams involved in capital investment, technology transfer, and operational… more
- Merck & Co. (Boston, MA)
- …with AI/ML use cases in bioprocessing (digital twins, predictive control , anomaly detection). - Demonstrated experience translating process /experimental ... DescriptionWe are seeking an experienced Technical Product Manager to lead pharmaceutical process and meth od development data product portfolio. This unique - role… more
- Capital One Bank (Chicago, IL)
- …quantitative methodologies (COSO Framework, quantitative analysis, Factor Analysis Information Risk (FAIR), Process , Risk & Control (PRC) library, Risk and ... within TDRM are highly-skilled information security, cybersecurity, site reliability engineering , technology, data analyst, data scientist, and risk management… more
- Merck & Co. (Rahway, NJ)
- …Cost Management, Driving Continuous Improvement, Global Sourcing, Inventory Control Management, Logistics, Logistics Management, Management Process , ... exert procurement influence, ensuring consistent application of sourcing across engineering , construction, equipment, and automation categories for all capital… more
