- BD (Becton, Dickinson and Company) (Warwick, RI)
- …KPIVs and KPOVs to ensure effective equipment selection as well as informing process validation strategy. + Design new assembly processes that are efficient, ... + Demonstrated experience leading/deploying Advanced Manufacturing initiatives. + Experience in process validation , writing protocols and reports to support… more
- Endo International (Hobart, NY)
- …**Production Processes Managed** Conducts reviews and approvals of equipment, product, and process validation documents and cleaning validation documents. ... processes. Ensures that processes comply with all cGMP regulations regarding process and cleaning validation . Completes exception investigations, identifies and… more
- Insight Global (Maryville, TN)
- …automation with tactical execution experience. MES/ERP integration, robotics, process validation , standardization, technology pilots. Collaboration, ... Job Description As a Process Engineer, you'll be the tactical driver of...will involve a mix of office-based planning and hands-on validation , with roughly 50% of your time spent engaging… more
- Edwards Lifesciences (Draper, UT)
- …Actions (CAPAs), and Engineering Change Requests (ECRs) related to both production and process validation . **Metric Definition and Monitoring** + Define and lead ... complaints related to manufacturing issues. + Support product release activities, including process validation , to ensure compliance and product quality. **… more
- J&J Family of Companies (Irvine, CA)
- …guidance on process characterization, risk assessments, and basic process validation activities. **Regulatory & Documentation Support:** Contribute to ... techniques. Proficiency in prototyping tools (SolidWorks, AutoCAD); familiarity with validation methodologies and process excellence tools. + Ability… more
- Lilly (Indianapolis, IN)
- …interpretation, and release of data including data released from CM, stability, process validation , and reference standard characterization. + Utilizes technical ... perform testing as required. + Contribute to APR, tech transfer, and process validation as required. + Communicate effectively in both written and oral formats… more
- Amgen (Juncos, PR)
- …Puerto Rico site. Oversight responsibilities span commercialization through full scale process validation and life-cycle management of processes and methods ... substance technology and analytical method transfer to and from the site + Process validation at scale across the two DS manufacturing plants + Drug substance… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …CMOs, ensuring robust, reproducible, and compliant implementation. + Lead API process validation activities, including strategy, protocol design, execution ... maintain systems and procedures for best practice in commercial technology transfer and process validation . + Build and oversee a central knowledge base of API … more
- Astellas Pharma (Sanford, NC)
- …(P&IDs), and User Requirement Specification (URS) development + Experience with process validation and lifecycle management + Experience supporting commissioning ... ** Process Engineer** Do you want to be part...Automation, Supply Chain, Warehouse, Technical Development, Quality, Regulatory, Facilities, Validation , and various vendors. This role is based in… more
- TAI (Rockville, MD)
- …manage projects from concept through detailed design, performing tasks like equipment sizing, process validation , and implementing control systems. If you have a ... regulatory requirements and quality standards. + Conducting risk assessments and process validation . + Implementing process automation and control systems. +… more