- Novo Nordisk Inc. (West Lebanon, IN)
- …needed Represent the Validation department on cross-functional teams (Manufacturing, Engineering , Technical Support and Quality groups) Assist in the ... processes Root cause analysis techniques and cGMP documentation practices cGMP regulations, GMP and other industry standards pertaining to validation Technical… more
- Merck & Co. (Rahway, NJ)
- …Decision Making, Detail-Oriented, Maintenance Supervision, Manufacturing Process Validation , Manufacturing Quality Control, Manufacturing Scale-Up, ... post-market commercial manufacturing support. BDSC supports stage 1 & 2 process validation deliverables (2011 FDA process validation guidance) including various… more
- Merck & Co. (Durham, NC)
- …manufacturer? If so, then this is the opportunity for you! The Sr. Tech, Engineering is a member of the Engineering team providing technical support to ... The site includes clean utilities, facilities equipment, manufacturing production equipment, quality labs and a warehouse. The candidate will support the… more
- Insmed Incorporated (San Diego, CA)
- …clinical GMP drug substance and drug product production and quality control operations. This role combines technical leadership in equipment lifecycle management ... leading the procurement, installation, and qualification of instruments and equipment for GMP manufacturing and quality control (QC), with the flexibility to… more
- Merck & Co. (Durham, NC)
- …manufacturer? If so, then this is the opportunity for you! The Lead Tech, Engineering is a member of the Engineering team providing technical support within ... Maintenance (PM) plans as requested. Responsible for SAP transactions, validation testing support, supporting root cause investigations and change control… more
- Aequor (Thousand Oaks, CA)
- …B20 plant to add value to the network: Manufacturing, Process Development, Supply Chain, Quality , and Facilities & Engineering . A high degree of interactions and ... management when appropriate. Reviewing protocols for manufacturing activities and partnering with Quality Assurance to ensure that GMP standards are maintained… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of commercial and clinical capacity.Build strong partnerships with Manufacturing, Supply Chain, Engineering , MS&T, and Quality to ensure seamless execution of ... scale cGMP manufacturing, operations management, tech transfer, process and equipment validation or quality management; with a preference for Cell/Gene… more
- Eisai, Inc (Exton, PA)
- …into the production suites.The Associate Director writes, reviews, and/or approves GMP documents, including validation protocols and reports, and SOPs, ... Interact cross-functionally with Support Services, Facilities, Biologics Process Development, Quality Assurance, Quality Control, Validation , and… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …(Downstream) Essential Functions Assist with coordinating fabrication, procurement, installation, engineering start-up, verification and validation activities of ... the Manufacturing Engineering department on cross-functional teams (Manufacturing, Engineering , Technical Support and Quality groups) Performs all job… more
- Merck & Co. (Durham, NC)
- …and implementation of new systems which enhances the operation and/or engineering processes. Quality & Safety Compliance:The successful candidate should be ... make our products. We work in the manufacturing plants with a "Safety First, Quality Always" mindset striving for continuous improvement. We work in the local plant… more
- Insmed Incorporated (San Diego, CA)
- …participate in the process execution within a Pilot Plant non- GMP manufacturing environment.Review batch records, SOPs, raw material specifications, protocols ... and author development reports.Demonstrated experience with process validation and scale-down models for biopharmaceutical processes, including interpretation of… more
- Aequor (Waltham, MA)
- …Quality System records, manufacturing documents, analytical methods, and qualification/ validation documentation. On-site oversight of CMO operations as needed. ... and preventive actions. Suggest the development, implementation, and maintenance of quality systems, processes, and procedures related to GMP operations… more
- Krystal Biotech (Pittsburgh, PA)
- …& Desired Competencies: Bachelors' Degree in Chemical Engineering , Biomedical Engineering , or related Relevant validation and/or engineering experience ... Job Description Summary: Krystal Biotech is seeking a highly motivated Process Validation Associate (1+ years' experience) or Engineer (3+ years' experience) to… more
- Quality Chemical Laboratories (Wilmington, NC)
- Quality Chemical Laboratories (QCL), a leading Pharmaceutical testing and manufacturing laboratory in Wilmington, is seeking a qualified candidate for the position ... of Validation Engineer. This position, in the Manufacturing and Formulations...a Bachelor's degree or higher in a scientific or engineering discipline with either 3 years of experience or… more
- Sotera Health Services, LLC (Grand Prairie, TX)
- …Must effectively interface with Sales, Operations, Corporate EO Technology, Laboratory, EHS, Quality , Engineering and other Sterigenics' facilities, as well as ... of IQ/OQ/PQ activities of new or existing facility equipment. Maintains the quality and integrity of information required for validation records. Liaison… more
- Cytiva (Miami, FL)
- …a Science or Engineering discipline.Multiple years working experience in Quality Assurance/ Quality Engineering . Experience in equipment qualifications, ... for the validation strategy and maintain ownership of the Muskegon site Validation Master Plan.This position reports to the Quality Assurance Manager and is… more
- Katalyst HealthCares and Life Sciences (Tarrytown, NY)
- … GMP regulations. Collaboration: Work closely with cross-functional teams, including engineering , quality , and operations, to ensure seamless integration and ... validation of new systems. Regulatory Compliance: Ensure that all validation activities meet GMP regulatory requirements, contributing to the safe and… more
- Bristol-Myers Squibb Company (Bothell, WA)
- …IT, Manufacturing, Quality Control, Supply Chain, Quality Assurance, and Quality Engineering Validation ) to manage workload to address priorities, ... compliance, quality , and continuous improvement within the validation team. Stay abreast of all relevant GMP...cell therapy industry is plus. Detail oriented, with strong GMP , Validation and Engineering experience… more
- Pharmavise (Lebanon, PA)
- …(C&Q) Proficiency in equipment and automation validation as applied in a GMP regulated area Bachelor's degree in Engineering , Biomedical Engineering , or ... We collaborate with our partners by providing technical expertise in Quality , Regulatory Compliance and Manufacturing Science and Technology. Our business mission… more
- JobScanner (Mooresville, IN)
- …Werum PAS-X, or similar is strongly preferred. Additional Preferences Understanding of GMP regulations and Computer System Validation (CSV) principles (eg, ... and site teams, MES System Engineer will ensure compliance with validation requirements, and proactively address technical, operational, and business challenges.… more
