- Insmed Incorporated (San Diego, CA)
- …strategic leadership and decision making on CSV strategy Develop risk-based validation strategies for system implementation and changes following CSV SOPs and ... Work Instructions Coordinate all validation activities with outsourced validation vendor when...accommodation to participate in the job application or interview process , please contact us by email at ###@insmed.com and… more
- Cipla (Fall River, MA)
- …Track and manage periodic review. Develop strategies and documents for cleaning and process validation of API equipment and products in compliance with site ... vary based on business needs) Reports To : Manufacturing Manager Salary Range: $62,400 - $75,400 Purpose: The content...of e-batch record & e-Log Book. Knowledge of cleaning validation and process validation . Knowledge… more
- Cipla (Hauppauge, NY)
- …General: 8:30AM - 5:00PM (may vary based on business needs) Reports To : QA Validation Manager Salary Range: $68,000 - $74,600 Purpose: The incumbent to this ... Job Overview Responsible for the coordination of supportive equipment and process validation activities such as testing, calibration, scale-up, engineering… more
- ValSource, Inc. (Rahway, NJ)
- …industries throughout each of our regions in the US. The Commissioning, Qualification & Validation (CQV) Project Manager will interface with our clients and be ... used in the FDA regulated pharmaceutical and biotech manufacturing industries. Project Manager is responsible for managing and executing validation projects… more
- Insmed Incorporated (NJ)
- …periodic reviews, and audit trail reviews.What You'll Do: Develop risk-based validation strategies for system implementation and changes following CSV SOPs and ... Work Instructions Coordinate all validation activities with outsourced validation vendor when...processes (both in ServiceNow and the GxP IT CAB process ) Who You Are:5+ years' experience in a management… more
- BioAgilytix (San Diego, CA)
- …you enable life-changing, life-saving therapeutics to the patients who need them.The Manager II will lead scientific and operational activities in support of ... and metabolite profiling/ID. You'll guide a team of scientists through assay development, validation , and sample analysis under GxP, while also playing a key role in… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …while liaising with other functions including but not limited to Tech Support, Process Improvement, Validation , Supply Chain, Operations, QA, Reg CMC, and IT. ... in the treatment of multiple myeloma.Legend Biotech is seeking MES Project Manager as part of the Manufacturing Excellence team based in Raritan, NJ.Role… more
- Merck & Co. (Rahway, NJ)
- …and Experience: Experience in drug development or manufacturing, including process or analytical development, characterization, technology transfer, validation ... the Development Sciences and Clinical Supply (DSCS) organization, the Digital Project Manager will streamline the execution of our Company's DSCS Digital Strategy to… more
- ACROBiosystems Inc. (Boston, MA)
- …support drug development and clinical applications from target discovery and validation , candidate drug screening and optimization, CMC development, preclinical and ... to excellence in providing quality products and services and accelerating the process of therapeutic development. Our mission is to accelerate the process… more
- ACROBiosystems Inc. (San Jose, CA)
- …support drug development and clinical applications from target discovery and validation , candidate drug screening and optimization, CMC development, preclinical and ... to excellence in providing quality products and services and accelerating the process of therapeutic development. Our mission is to accelerate the process… more
- ValSource, Inc. (Worcester, MA)
- …Responsibilities include, but are not limited to: Reporting to the clients Process Engineering or Area Manager , while demonstrating independent drive and ... at the Client site. Manage multidisciplinary teams with representatives from Process Engineering, Automation, Commissioning, Qualification & Validation (CQV) and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and market data, and present to cross-departmental teams Guide assessments and validation of wholesaler performance and fees earned Ensure optimal supply of product ... analytics tools preferred Novo Nordisk is currently in the process of adjusting job titles globally. Please note that...More detailed information will be provided during the recruitment process . The base compensation range for this position is… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …at our bioproduction facility in West Lebanon, NH. Relationships Reports to: Manager , Process Support (Downstream) Essential Functions Assist with SOPs, JIs, ... The Position This role will be part of our bioproduction downstream purification process support team, dedicated to one of our manufacturing suites. Responsible for… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …and build your career. Are you ready to realize your potential? The Position A process engineer on the cleaning team is a process engineer who specializes in ... requirements. They are responsible for the development of cleaning processes, the validation of those processes, and for monitoring those processes during routine… more
- Merck & Co. (Durham, NC)
- …Maintenance (PM) plans as requested. Responsible for SAP transactions, validation testing support, supporting root cause investigations and change control ... to perform routine maintenance tasks, work with and troubleshoot complex process systems, including but not limited to:Utility Equipment (eg boilers, chillers,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with stakeholders across the Finance organization with frequent interaction at the manager , senior manager and director level. Moreover, the job regularly ... Functions Model development and implementation Data, logic, and quality validation User support and continuous improvement Cross functional collaboration Key… more
- Cipla (Hauppauge, NY)
- …during batch manufacturing, as per manufacturing record instructions. Collection of in- process blend, finished product, validation samples for analysis, sample ... with established procedures.Responsibilities: Verification of raw materials during the dispensing process . To perform posting of dispensed materials and samples into… more
- Cipla (Hauppauge, NY)
- …packaging, as per manufacturing & batch packaging record instructions. Collection of in- process blend, finished product, validation samples for analysis, sample ... established specifications. Verification of raw materials during the dispensing process . Dispensing printed packaging materials to packaging. Perform in- process… more
- Cipla (Hauppauge, NY)
- …packaging, as per manufacturing & batch packaging record instructions. Collection of in- process blend, finished product, validation samples for analysis, sample ... Essential Functions: Verification of raw materials during the dispensing process . Dispensing printed packaging materials to packaging. Perform in- process… more
- BioAgilytix (Durham, NC)
- …to the patients who need them.Essential ResponsibilitiesServe as Bioanalytical Project Manager on a project (BPM)/Principal investigator (PI)May prepare and submit ... of deviationsPerform assays according to GLP guidelinesFollow GLP guidelines for validation of assays - run assays independentlyPrepare worksheets independently -… more
