- Merck & Co. (Durham, NC)
- …in media preparation, vaccine filling, lyophilization, and capping/inspection unit operations, including engineering runs and process validation lots of ... necessary for development studies, cleaning, sanitization, depyrogenation and sterilization process validation .Participate in the feasibility activities working… more
- Merck & Co. (Rahway, NJ)
- …also involves collaboration (largely remotely) with external suppliers while managing process development and validation activities. Travel is expected ranging ... engineering fundamental conceptsPrincipled verbal and written communicationsExperience with process scale-up and technology transfer, moving from the laboratory… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …with project team to identify roles and responsibilities Work closely with Engineering , Automation, Validation , IT, Manufacturing, Quality Assurance and Quality ... in cGMP documentation practice & understanding of change control processes Expert understanding of validation /system development life cycle approach Basic… more
- Merck & Co. (Rahway, NJ)
- …build Quality Management System elements into the end-to-end computer system validation process , thereby promoting permanent inspection readiness.Develop and ... for and lead Quality Assurance oversight for computer system validation matters within the Global Development Quality organization and...maintain a subject matter expert level of understanding for the company's Policies, Procedures… more
- Catalent (St. Petersburg, FL)
- …b) process improvement projects and Product Development Projects; c) all product process validation and cleaning validation documents; d) all Preventive ... on trend analysis to eliminate future problems. Participates in Product Development/ Validation / Engineering project meetings to provide Quality Assurance input… more
- Aequor (Austin, TX)
- …and Capital Equipment Global Category Management (GCM) teams Be the Procurement Process and Systems expert ensuring compliance with all relevant global ... you use (or have used in recent years) to issue, score and select you engineering and construction suppliers? (5) What contracting e-tool(s) do you use (or have used… more
- Eisai, Inc (Nutley, NJ)
- …training documents to ensure optimal use of tools.As "Subject Matter Expert " this position interprets key business reports providing business insights/cause effect ... to the reported information.This position develops and maintains reporting and validation testing standards for the department, and monitors compliance with these… more
- ASSA ABLOY Americas (Rockwood, PA)
- …of strategies for Product Data, Document Management (PDM), and sustain formalized Engineering Change Process for the team. Development and implementation of ... of NPD through to production on time across all product groups Lead Engineering Change Management Process Standardization of NPD and existing product change… more
- NS International, Ltd. (Troy, MI)
- …team.Establish and review software validation documentation per the development process ; create software validation process documentation in accordance ... OEM's. #LI-DNI Purpose of JobThe role of a Software Validation Supervisor is to lead a team comprised of...identifies, assesses, and mitigates operational risks as well as process improvements to reduce delivered software defects; escalates key… more
- Abbtech Professional Resources (Huntsville, AL)
- …to the client on all technical logistics efforts, integration with the systems engineering process and team, and attend all scheduled meetings as required ... prepare for and take part in system test planning and execution, verification, and validation events as required. Will assist in the development of in- process … more
- Lennar Homes (Murrells Inlet, SC)
- …be responsible for assisting the DOP, Starts Manager and Permitting Manager with the process of starting a new home. This includes site turnover walks, plot plan ... and approval of all plot plans used for permitting. Expert on grading for the communities Field Verification Manager...from the field. Field inspection and verification of architectural, engineering , and materials on all new prototype homes. Field… more
- Arthrex (Goleta, CA)
- …products in service channels, and field and repair center. Provides test engineering support through optimizing test procedures and test equipment. Works with ... repair and complaint investigations during design for reparability, qualification, and validation . Collects and analyzes Root Cause Investigation data to help with… more
- American Honda Motor Co Inc (Raymond, OH)
- …and Lead the design of complex assemblies, the associated drawings, engineering specifications/standards and validation processes as required. Conceive and ... At the Engineer II Career Level, you are an expert in related technical areas and expected to oversee...lead the development of engineering specifications and standards or functions to guide … more
- DCS Corp (Bedford, MA)
- …enterprise; including supply, distribution, materiel management, acquisition, system engineering and maintenance, financial planning and budgeting, security, flight ... of program status and acquisition tasks to senior management. Provide expert Program Management inputs to Request for Proposal (RFPs) including systems… more
- Amerant Bank (Coral Gables, FL)
- …technology trends, and define digital solutions. This will include understanding the process , people, technology, and data required to execute. Partner with change ... as needed by end usersCreate and manage custom objects, fields, formulas, validation rules, custom workflow, and approval processesServe as the internal Subject… more
- V2Soft (Tallahassee, FL)
- …the systems maintained by BSE.The person in this position: Is a technical expert in all phases of system development. They must understand business, business insight ... Technical Design Document (TDD), Solution Design Document (SDD), high-level process flow diagrams, designs and requirement traceability matrices of solutions.… more
- Bristol Myers Squibb (Bothell, WA)
- …lives. Read more: careers.bms.com/working-with-us . **Position Summary** The Senior Manager, Validation , Engineering and Technology is responsible for supporting ... Operate, Operational Excellence and Ongoing Monitoring area within the Validation , Engineering & Technology (VET) team. The...principles and data integrity requirements. + Act as a validation Subject Matter Expert (SME) providing support… more
- Micron Technology, Inc. (Boise, ID)
- …communicate and advance faster than ever. Our Opportunity Summary As a DRAM Engineering Group (DEG) Validation Manager at Micron Technology, your team will ... goals, encouraging career development, and conducting performance appraisals. * Own the validation workflow which includes constantly improving our process with… more
- Regeneron Pharmaceuticals (East Greenbush, NY)
- … Sciences Drug Product Engineering department. This role is responsible for process controls and process validation for labeled drug product (LDP) ... & Drug Product Engineering departments through design transfer, technology transfer, process validation , regulatory filing, and lifecycle management. As a … more
- Kelly Services (Frederick, MD)
- ** Process Validation Scientist** + Demonstrate specific upstream cell culture and downstream purification unit operations knowledge in support of bioprocessing ... of large molecule biologics + Lead Process Validation (Stage 3) activities...the role:** + Bachelor's Degree preferably in Science or Engineering . Master's Degree or PhD preferred. + At least… more