- BeiGene (Hopewell, NJ)
- …SOP's, Comparability Reports, Aseptic Process Simulation Protocols and Reports, Cleaning Validation , Process Validation (PPQ). + Lead validation ... as a point of contact with different business areas, lead and handle validation projects, ensure the...aseptic processing knowledge required. + Knowledgeable in Computerized System Validation (CSV), Cleaning Validation , Process … more
- Lilly (Concord, NC)
- …and technical organization from the ground up. The Principal Scientist/Engineer - Cleaning Validation /Sterilization Validation - Technical Services / ... and implementation of validation strategies, including sterilization validation , cleaning validation , filter .... Provide technical guidance to the Process Team for cleaning and sterilization processes. . Lead or… more
- VTI Life Sciences (San Diego, CA)
- …We are looking to staff a Validation Engineer with strong experience in cleaning validation and temperature mapping for a 9+ month project with our ... assignments. + Provide swab, rinse and visual inspection for cleaning validation sampling + Perform temperature mapping...+ Review planned/unplanned events and provide initial assessment for validation lead . + Review of lifecycle documents… more
- Takeda Pharmaceuticals (Social Circle, GA)
- …automation qualification with Honeywell, Delta V, and PCL-based systems + Computerized systems validation + Cleaning validation + Sterilization validation ... platforms, such as DeltaV, Honeywell, Rockwell PLC, Siemens XFP. + Lead validation projects, coordinate contractors, and improve results. + Direct experience… more
- STERIS (Minneapolis, MN)
- …life science product and service solutions around the globe. Position Summary The Lead Validation Service Engineer is responsible for meeting STERIS product ... training, consultative, and technical support to STERIS and its Customers. The Lead Validation Engineer must have sound knowledge and have demonstrated… more
- Citigroup (Wilmington, DE)
- …lifecycle including validation , ongoing performance evaluation, and annual reviews. + Lead the validation and testing of fraud detection models, including ... The Specialized Analytics Sr Lead is a strategic professional who closely follows...statistical analysis, data validation and model performance evaluation. + Provide strategic guidance… more
- Takeda Pharmaceuticals (Boston, MA)
- …meet demands in the manufacturing facility by building partnerships across departments. + Lead and represent the respective validation elements to determine ... such as (21 CFR Parts 210, 211, 600, ISO 14644, EC-Annex1). + Plan, and schedule validation assignments and lead the validation team to prepare protocols and… more
- ICU Medical (Dublin, OH)
- …For Process and Cleaning : Technical Transfers of products . Execution of validation documents to support company goals . Development of validation procedures ... and validation gap analysis as required. . Plan and lead revalidation of existing plant equipment (including sterilization equipment), facilities, utilities,… more
- ThermoFisher Scientific (Middletown, VA)
- … validation principles and regulatory requirements. + Strong understanding and proficiency in cleaning validation and cleaning process design. + Must be ... **Job Description** **Job Title:** ** Validation Engineer III** Reports To: Sr. Manager, Manufacturing...data in accordance with FDA and ISO requirements. + Lead and/or assist in training of staff involved in… more
- Takeda Pharmaceuticals (Social Circle, GA)
- …automation qualification with Honeywell, Delta V, and PCL-based systems, Computerized systems validation , Cleaning validation , Sterilization validation , ... the following applicable areas: + Sterilization and aseptic processing validation . + Cleaning validation of...such as DeltaV, Honeywell, Rockwell PLC, Siemens XFP. + Lead validation projects, coordinate contractors, and increase… more
- ThermoFisher Scientific (Middletown, VA)
- …prioritization changes in a fast-paced environment. + Strong understanding and proficiency in cleaning validation and cleaning process design. + Must be ... is safe or helping find cures for cancer. The Validation Staff Engineer is responsible for leading / assisting...data in accordance with FDA and ISO requirements. + Lead and/or assist in training of staff involved in… more
- Takeda Pharmaceuticals (Social Circle, GA)
- …automation qualification with Honeywell, Delta V, and PCL-based systems + Computerized systems validation + Cleaning validation + Sterilization validation ... the following applicable areas: o Sterilization and aseptic processing validation . o Cleaning validation of...such as DeltaV, Honeywell, Rockwell PLC, Siemens XFP. + Lead validation projects, coordinate contractors, and achieve… more
- Takeda Pharmaceuticals (Los Angeles, CA)
- …+ Review and change control requests with potential impact to validated state of validation elements, as applicable. + Lead and interface with team members ... knowledge. **Job Description** **About the role:** You will have engineering validation oversight and engineering validation signatory responsibility for… more
- Teva Pharmaceuticals (West Chester, PA)
- …completion of projects per schedule requirements. Also, contribute to the development of Validation Master Plans, Cleaning Validation Plans, and Computer ... standards and procedures, and implementing industry best practices. The Validation Engineer III will lead , organize, and...best practices. The Validation Engineer III will lead , organize, and execute Validation activities to… more
- Regeneron Pharmaceuticals (East Greenbush, NY)
- …Validation department at Regeneron is adding to their team! The **Manager for QA Validation within our Fill Finish area** would lead the department that is ... responsible for qualification of equipment, utilities, software, and validation of cleaning and sterilization processes in Regeneron's Rensselaer facility. This… more
- Medtronic (Beverly, MA)
- … validation of manufacturing/extrusion processes, facility, equipment, system and cleaning processes. You will evaluate impact of proposed changes to utilities, ... execution. + Responsible for evaluation and analysis of data, lead investigation and documentation of all validation ...data, lead investigation and documentation of all validation deviations and determine impact on the validations. +… more
- ADM (Erlanger, KY)
- …Support the sanitary design & GMP elements of new & existing project developments. + Lead the cleaning validation Program and approval across all cleaning ... Erlanger, KY** The role of Sanitation Manager is to lead the sanitation, GMP & pest control agendas across...Responsibility to review and approve the internal and contracted cleaning schedules/plans and pest control plans to ensure they… more
- PCI Pharma Services (Bedford, NH)
- …materials. Job duties may also include performance of instrument validations, cleaning validations, and method qualifications as deemed appropriate by management. ... in-process production, finished product release, long term stability and validation samples.** **.** **Ability to independently troubleshoot and solve assay… more
- Trinity Health (Grand Rapids, MI)
- …or a functional area within the pharmacy. Assists Manager in training, competency validation , coaching of staff for adherence to standard work, maintenance of key ... exposure to hazardous and toxic substances (including chemotherapy, cytotoxic drugs, and cleaning solutions). Potential for sticks or cuts by needles and other sharp… more
- The Ritedose Corporation (Columbia, SC)
- …providing guidance for analytical testing related to raw materials, compounding and cleaning validation support activities, and final product and stability ... The Analytical Services Chemist Lead role is for a laboratory professional, subject...investigations, etc. + Responsible for developing and proposing method validation strategies and performing tests associated with method validations… more