- Fujifilm (Holly Springs, NC)
- **Position Overview** The Director , Process Validation plays a pivotal role in providing technical leadership and strategic vision within the Manufacturing ... collaboration to drive continuous improvement and adherence to regulatory standards. The Director , Process Validation is crucial in enhancing the site's … more
- Lilly (Indianapolis, IN)
- …expectations and business objectives. **The Senior Advisor/ Director , MSAT Global Process Owner for Sterilization Validation QMS is responsible for these ... Assurance function and capability to provide increased technical sterilization validation capacity across the network. **Position Brand Description:** + The… more
- Jabil (Hunt Valley, MD)
- …and ensuring the proper validation of all equipment and processes. The Validation Director will also schedule the appropriate resources for assistance with ... and diverse communities around the globe. Job Summary: The Director of Validation will lead all ...alignment with corporate quality and operational goals. + Assess process validation capabilities within the Operations organization… more
- Fujifilm (Holly Springs, NC)
- …to ensure full CGMP compliance by operations launch * Ensures the integration of process validation (PV), CV, and computerized system validation (CSV) into ... **Position Overview** The Associate Director , Cleaning Validation is responsible for...This role ensures that all facility, utility, equipment, and process qualification activities are conducted efficiently and in alignment… more
- Teledyne (Loomis, CA)
- …or equivalent validation ecosystems a plus. + Exposure to NPI process as part of product development. + **Skills:** + Excellent communication and organizational ... workflows highly desirable. **Success in This Role** Success as OakGate's Director of Engineering means delivering reliable, innovative validation platforms… more
- Lilly (Pleasant Prairie, WI)
- …previous facility or area start up experience + Has previous qualification and validation experience ( process automation and/or IT systems) + Has previous Six ... that impact the site and align with corporate objectives. The Associate Director , Quality Assurance, will also provide computer system quality assurance oversight… more
- SMBC (Jersey City, NJ)
- …its employees. **JOB SUMMARY:** Reporting to the Head of Model Risk, the Risk Model Validation Director plays an active role in the implementation of Model Risk ... the Combined US Operations of SMFG by performing independent validation and review of Stress Testing Models. **SCOPE:** As...about their specific hybrid work schedule during their interview process . Hybrid work may not be permitted for certain… more
- Ankura (Houston, TX)
- Ankura is a team of excellence founded on innovation and growth. The Model Validation Director is expected to lead and execute model validation testing ... below-the-line testing, statistical analysis) which will aid in the independent validation of financial crimes detection and sanctions screening models. Testing… more
- US Bank (Minneapolis, MN)
- …excel at-all from Day One. **Job Description** US Bank is seeking an experienced Model Validation Director for our Treasury & Markets risk areas and will reside ... management and quantitative backgrounds. + Interface with key stakeholders throughout validation process , regulators and internal audit to discuss justification… more
- Stantec (New York, NY)
- …design intent and client/user and regulatory requirements. Working under the guidance of Director of commissioning/ validation , you will work on a variety of ... reports to assist in closure of protocols. - Assist Director of Commissioning/ Validation with client presentations, client...At Stantec we are committed to ensuring our recruitment process is accessible to all. If you require reasonable… more
- PCI Pharma Services (Rockford, IL)
- …ISO 14971, and GAMP 5 principles. + Hands-on experience with equipment and process validation on assembly lines (manual, semi-automated, or fully automated). + ... Development and Manufacturing Organization (CDMO). The ideal candidate will lead equipment, process , and cleaning validation efforts to ensure compliance with… more
- Unither Pharmaceuticals (Rochester, NY)
- …are completed. Validation Protocols and Documentation (200%) Writes validation protocols ( process validations for, manufacturing and packaging processes. ... Computer Systems Validation Specialist Who we are? We are a...than 280 employees. Your role Reporting to the Quality Director , JOB SUMMARY: This is a team-oriented position with… more
- Community Health Systems (Franklin, TN)
- …who needs a reasonable accommodation for any part of the application or hiring process , contact the director of Human Resources at the facility to which ... Summary** As a Senior Cybersecurity Engineer in the Security Validation team, you will be a key member of...insider threats, aligned with MITRE ATT&CK. + Conduct Security Validation Exercises across cloud, on-prem, hybrid, and medical environments… more
- BeOne Medicines (Pennington, NJ)
- …eBR, eLogs, etc.. + Technical Transfer experience including equipment qualification, process validation , and computer system validations. + Hands-on experience ... **General Description:** The Director , Process and Automation Engineering is...with process and equipment design, change management, process and equipment validation . + Direct project… more
- Takeda Pharmaceuticals (Boston, MA)
- …Technology Transfer from/to external CMOs and/or internal manufacturing sites. Process validation , Risk assessment, Global expansion, COGs management, ... Description** **Title: Process Engineer Small Molecules API Process Science (Associate Director )** **Location: Cambridge, MA...and procedures for best practice in commercial technology transfer, process validation . + Lead the team that… more
- Lilly (Raleigh, NC)
- …provide increased technical capacity across the network. **Position Brand Description:** The Director /Senior Director , Global Process Owner for Sterility ... agency standards, industry trends and scientific principles. **Key Objectives/Deliverables** **The Director /Senior Director , Global Process Owner for… more
- Fujifilm (Holly Springs, NC)
- …associated support functions such as Process Science, Engineering Science, Process Engineering, Validation , and Automation + Ensures the quality assurance ... standards + Approves critical lifecycle documentation, including risk assessments, product/ process /equipment specifications, functional specifications,traceability matrices, qualification protocols, validation… more
- Lilly (Indianapolis, IN)
- … Process Research & Development group on commercialization (technology transfer, process validation and regulatory approval) of Lilly's exciting leading ... to make life better for people around the world. The Associated Director of the Joint Process Team (JPT) is responsible for leading a cross functional team… more
- Takeda Pharmaceuticals (Boston, MA)
- …Units: + Technology Transfer to both CMOs and Takeda sites. + Drug Product manufacturing process validation . + Serve as the expert for rapid response teams. + ... Science GMSci DP/PKG** **Location: Cambridge, MA** **About the role:** As a Process Scientist (Associate Director ) - Global Manufacturing Science GMSci Drug… more
- Lilly (Indianapolis, IN)
- …site. + Lead and/or support the development and execution of FAT, commissioning and validation of equipment and process workflows in alignment with TS/MS and ... knowledge of cGMPs and CQV activities. + Proficient in qualification and validation requirements for manufacturing equipment and process changes **Additional… more