- Catalent Pharma Solutions (Harmans, MD)
- **Senior Engineer, Process Validation ** **Position Summary:** Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose ... patients. Catalent Pharma Solutions in Harmans, MD is hiring a Senior Process Validation Engineer who is responsible for the qualification of cGMP manufacturing… more
- Boehringer Ingelheim (Fremont, CA)
- …current college or university **Desired Experience, Skills and Abilities:** + _Knowledge in Process Validation and CPV is preferred._ + _Experience with planning ... is currently seeking a talented and innovative Intern to join our _MSAT Process Validation_ department located at our _Fremont_ facility. As a Co-op student, you… more
- Fujifilm (Holly Springs, NC)
- **Position Overview** The Engineer or Scientist 2 for Process Validation helps ensure that manufacturing processes meet the validation and regulatory ... This role contributes to the design, execution, and documentation of process validation protocols for equipment, systems, and manufacturing processes.… more
- Danaher Corporation (Fargo, ND)
- …development and delivery of solutions that safeguard and improve human health. The Process Validation Engineer II is part of the Technical Operations Department ... groundwork for vital new discoveries worldwide. You will be a part of the Process Validation team and report to the Process Validation Supervisor… more
- Marriott (Bethesda, MD)
- …**Position Type** Management This is a temporary position. The FLEX Senior Manager, Business Process Validation (BPV) is a critical role on the BPV team, ... to track progress (eg, JIRA, Confluence, etc.) + Representative for Business Process Validation and able to pull through and amplify core Program messages. +… more
- Regeneron Pharmaceuticals (East Greenbush, NY)
- …support to a variety of activities such as technology transfer, design transfer, process control strategy development, process validation lifecycle and/or ... product and process risks during technology transfer, design transfer, process control strategy development, process validation lifecycle and/or… more
- Regeneron Pharmaceuticals (Rensselaer, NY)
- …process development team. + Analyzing development studies, enrichment studies, process validation and characterization studies, chemical stability studies, ... Regeneron is looking for a Sr. Process Controls & Validation Scientist for our Process Controls Development and Lifecycle Management Team. This is a… more
- Capgemini (Richmond, VA)
- …**Job:** _Programmer/Analyst_ **Organization:** _ERD PPL US_ **Title:** _Manuf & Process Technician - Validation Engineer_ **Location:** _VA-Richmond_ ... equipment meet regulatory requirements, company standards, and quality specifications. Validation engineers ensure that all equipment, production processes, and… more
- BeiGene (Emeryville, CA)
- …operations. + Lead the design, implementation, maintenance, and continuous improvement of validation and manufacturing process elements in the QMS. + Define ... **General Description:** Senior Director, Business Process Owner (BPO) for GxP processes, with a...(BPO) for GxP processes, with a specific focus on ** Validation and select Manufacturing** processes within the **Quality Management… more
- Bristol Myers Squibb (Indianapolis, IN)
- …be the global leader in radiopharmaceuticals. The Sr. Manager, IT - GxP Computer Systems Validation & IT Process Lead is an integral part of bringing RayzeBio's ... validated for intended use including Validation Protocols including Validation Masterplans, Design documents, Process and Instrumentation Drawings, IQ,… more
- Actalent (St. Paul, MN)
- … process related documentation (ie batch records). Skills Equipment validation , Pharmaceutical, process validation , Quality engineering, regulatory, ... cgmp, fda, system validation Top Skills Details Equipment validation , Pharmaceutical, process validation Additional Skills & Qualifications + Required… more
- Curia (Rensselaer, NY)
- …Review the Master Batch Records (MBRs) of commercial products and assess the need of process validation based on the proposed process changes + Conduct ... to support the overall project timeliness and on-going projects + Author/review/approve process and cleaning validation protocols and master plans, supervises … more
- Kedrion Biopharma (Melville, NY)
- …of Fractionation intermediates and final sterile drug product. + Support execution of process validation activities. + Performs generation of summary reports for ... success through the commercialization lifecycle. **ESSENTIAL JOB FUNCTIONS** Supports Sr. Validation Specialist on process improvement projects. Works together… more
- Catalent Pharma Solutions (Harmans, MD)
- …electronic data integrity. + Review and approve Protocols and Summary Reports for Process Validation such as PPQ's, Engineering studies, Cleaning Validation , ... **Lead Specialist, QA Validation & Engineering** Catalent Pharma Solutions is looking...product. This position will provide continuous improvement support to process , equipment, utilities and computer systems and serve as… more
- Abeona (Cleveland, OH)
- …Bio, Physics, etc.) + 8+ years of experience in an Equipment and/or Process Validation Engineering role within a pharmaceutical or medical device company ... and regulatory issues. + Ability to design, execute and analyze manufacturing process validation studies. + Ability to manage multiple concurrent tasks/studies.… more
- Bristol Myers Squibb (Indianapolis, IN)
- …and operational support as required * Expand expertise in additional areas of validation ( process validation , QC assets, CSV, cleaning validation ... , etc) * Own and manage a specific area of validation (ie process validation , QC assets, CSV, cleaning validation , etc) * Apply technical knowledge and… more
- Actalent (Irvine, CA)
- …tools, and best practices. Skills Validation , quality engineering, ValGenesis, Validation protocols, Process validation , Medical device Top Skills ... We are seeking a highly skilled and experienced Quality Engineer/ Validation Engineer to join our team. In this role,...activities to address quality issues and reduce product and process nonconformities. Process Audits: Conduct audits of… more
- Kelly Services (Anasco, PR)
- …Must have knowledge in shelf-life validation (aging studies), sterile barrier sealing process validation and packaging validation . * Must have knowledge ... Biomedical. * Hands-on experience with ISO11607 remediation projects, compliance projects, process validation and/or packaging validation projects required.… more
- Astellas Pharma (Westborough, MA)
- …for commissioning and qualification of facilities/utilities, equipment, automated systems, and process validation . + Author, execute, review, and approve ... validation documentation for facilities/utilities, equipment, automated systems, and process validation and assist with resolving technical issues, evaluating… more
- Boehringer Ingelheim (St. Joseph, MO)
- … validation project activities at the BIAH location from concept through process validation ensuring GxP regulatory compliance continues as outlines in BIAH's ... validation project activities at the BIAH US locations from concept through process validation as outlined by BIAH's Validation Master Plan (VMP) and… more
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