- Lilly (Indianapolis, IN)
- …assembly and packaging processes. You'll ensure robust design, integration, and validation aligned to global standards while meeting site-specific needs. **How ... Exception, Recipe Management, Equipment Management, and EBR authoring. + Support validation activities including authoring/reviewing of design specs, test plans, and… more
- Cambrex High Point (Charles City, IA)
- …may be assigned. Qualifications/Skills + Strong knowledge of GMP regulations, validation practices, and pharmaceutical production processes. + Proficient in ... leadership for project management, engineering design, procurement, construction, and validation of facilities, utilities, and manufacturing equipment. The position… more
- Quality Consulting Group (Juncos, PR)
- …+ Support the execution of manufacturing/quality systems such as non-conformances, process validation , procedures, training, and new product introductions. + ... Root Cause Analysis investigations and support trend evaluations. + Assist with generation of process validation protocols and reports. + Participate in the NPI … more
- Lilly (Lebanon, IN)
- …technical documents supporting process control strategies, technology transfers, process validation , deviation/adverse event reporting, process ... audits. + As required, may lead or assist in the planning and execution of process validation activities. + As required, may own or assist in the implementation… more
- Lilly (Indianapolis, IN)
- …and their impact to the medical device design transfer and post-launch surveillance process . + Engage externally to ensure the organization stays current in the ... reports, and other related technical documentation. Oversee qualification and validation strategy for device and packaging processes. + Independently identify… more
- Quality Consulting Group (Juncos, PR)
- …as they apply to product or process quality. + Performs and/or review process validation (not cleaning processes) and equipment documents: URS, FAT, IQ, OQ, ... (preferably using Minitab). + Knowledge of equipment Commissioning/Qualification. + Knowledge of Process validation and Computer software validation (eg… more
- Quality Consulting Group (Juncos, PR)
- …(eg requirements flow down from design to manufacturing) + Perform and/or review process validation (not cleaning processes) and equipment documents: URS, FAT, ... QUALITY CONSULTING GROUP, a leader in the pharmaceutical , biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and… more
- Sartorius (Hondo, TX)
- …Lead Quality will be responsible for maintaining operational system (facility, utility, process equipment etc.) and processes are qualified and validated to meet ... their requirement together with system, process owners. Main Responsibilities & Tasks: + Set qualification...owners. Main Responsibilities & Tasks: + Set qualification and validation strategy for URS, DQ, FAT, SAT, IQ, OQ,… more
- J&J Family of Companies (Wilson, NC)
- …conceptual design, basis of design, detailed design, construction, commissioning/qualification, process validation , and regulatory submission/approval for this ... Requires a minimum of a bachelor's degree in science, Pharmaceutical Engineering, Engineering, Pharmacy, Biochemistry, Microbiology, Biology, Chemistry or Molecular… more
- Curia (Springfield, MO)
- …timely completion of the annual product reviews and assessment of the continued process verification and validation activities. + Single point contact of ... organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotech companies to provide life-saving treatments to patients. At… more
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