- Bristol Myers Squibb (Devens, MA)
- …for capital project teams performing validation activities of new equipment and standalone/enterprise laboratory computerized systems and/or changes to ... Validation Engineer I supports the successful implementation of manufacturing and laboratory equipment at multi-use sites through interaction with internal… more
- Takeda Pharmaceuticals (Boston, MA)
- …make recommendations. Identify compliance issues with equipment /software used at CTMF as the Subject Matter Expert ( SME ) in Computer System ... approvals, and ensures compliance with regulatory requirements. As a Subject Matter Expert ( SME...manufacturing process equipment , utilities, automation, computer systems, validation , and laboratory instruments. + Perform change… more
- Astellas Pharma (Westborough, MA)
- …+ Previous experience interacting with regulatory agencies, representing technical deliverables as a subject matter expert , audit hosting / support, etc. + ... Validation Specialist will ensure that all critical GMP equipment and systems are validated and maintained in compliance...qualification packages and create supplemental protocols as necessary. + SME for validation software, such as Ellab… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …high levels of noise in production areas. Exposure to electrical office and laboratory equipment . Personal protective equipment required such as protective ... * Actively manages and completes all phases of assigned equipment , facilities, utilities and process qualification and validation...data related to the project as well as coordinate validation activities. SME in high complexity /… more
- System One (Summit, NJ)
- …adhering to a change management process. + Supports the execution of equipment qualifications and validation protocols. + Supervises vendors for qualification ... and preventive maintenance of equipment . + Supports equipment qualification and validation activities. + Develops...maintained in compliance. + May be called upon as SME in both internal and regulatory audits. Requirements +… more
- Bristol Myers Squibb (Bothell, WA)
- …and qualification plans to support GMP operations. + Acts as a validation Subject Matter Expert ( SME ) providing support to multi-function teams, ... in GMP, a thorough understanding of lab /manufacturing equipment , and a proven track record in validation...inspections and audits, serving as the subject matter expert for validation processes.… more
- Takeda Pharmaceuticals (Social Circle, GA)
- … + Materials validation + Process validation + Provide technical subject matter expert ( SME ) support to change controls, investigations, ... Sterilization and aseptic processing validation . + Cleaning validation of manufacturing equipment . + Process and...may include safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hair nets and gloves… more
- Verista (Concord, NC)
- …+ Direct experience authoring/editing/executing validation documents for laboratory equipment (Cat. A, B &C) + Expert knowledge of FDA regulations, ... this role, validation engineers design and perform validation around lab equipment and...and, where warranted, makes recommendations + Act as the Subject Matter Expert for project… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …risk assessments and process parameter classification + Provide hands-on review and subject matter expertise of Validation lifecycle documentation including ... manner, and in support of corporate objectives + Act as the quality / validation SME for Change Controls supporting GMP/GLP systems. + Ensure required Standard… more
- Abbott (Columbus, OH)
- …the development and implementation of validation processes for laboratory equipment and test methods in the packaging lab , including validating existing ... and packaging software programs (ie. AutoCAD, SolidWorks, Cape Pack) + Experience in Laboratory equipment validation and Test Method Verification + Ability… more
- AbbVie (North Chicago, IL)
- …opportunities and cost reductions into policy, procedures, and good practices. + Develop into Subject Matter Expert in Abbvie's Paperless CQV initiative and ... members to plan, and complete tasks associated with commissioning, qualification and validation of new and modified equipment , facilities, utilities, product,… more
- Medtronic (North Haven, CT)
- …program initiatives and compliant with company best practices. They are a subject matter expert in mechatronics, equipment , equipment design, and ... and New Product Line Start-up, including Assembly and Test Equipment validation and qualification, associated with the...generate real solutions for real people. From the R&D lab , to the factory floor, to the conference room,… more
- Lilly (Durham, NC)
- …well as supporting internal and external audits as a laboratory IT system subject matter expert . **Key Objectives/Deliverables:** + Performs or supports ... IT systems and will be responsible for mentoring laboratory personnel on the use of electronic lab...Laboratory with the validation of laboratory equipment and… more
- Boehringer Ingelheim (Fremont, CA)
- …Group representative on simple or routine equipment qualifications. Serves as QC subject matter expert ( SME ) representing the department during ... Experience troubleshooting technical problems and/or equipment . + Subject matter expert in performing...OOS and CAPAs and change controls). Serves as QC subject matter expert ( SME… more
- Sutter Health (San Francisco, CA)
- …Med Center Van Ness **Position Overview:** $5,000 Sign-On-Bonus Functions as the technical and clinical subject matter expert in one or more areas of the ... level of safety and reliability in testing. **Job Description** : **JOB ACCOUNTABILITIES:** TECHNICAL SUBJECT MATTER EXPERT . * Functions as the technical and… more
- Pfizer (Bothell, WA)
- …the best outcomes for our business, and align with contemporary standards. + Serve as subject matter expert for one or more critical aseptic processing ... field within the pharmaceutical or life sciences industry + Subject matter expertise in ASHRAE standards +...and ICH regulatory requirements. Good working knowledge of GxP facility/ equipment validation requirements + Proficiency in CAD… more
- Lilly (Indianapolis, IN)
- …internal business customers. **Key Objectives/Deliverables:** DPEM Laboratory Secondary Loop Subject Matter Expert provides oversight, assistance, and ... the following: + Subject Matter Expert and Technical Mentor for Laboratory system...micro/sterility testing. + Strong Coaching/Mentoring skills. + Knowledge of laboratory quality system, method, and equipment . +… more
- AbbVie (Westboro, MO)
- …planning + Represent the company in Ministries of Health inspections as deemed necessary as a subject matter expert in the field of Microbiology + Foster an ... including but now limited to method validation , validation of cleanrooms, laboratory equipment validations, maintenance and calibration of business… more
- MD Anderson Cancer Center (Houston, TX)
- …Leadership** - Supervises the daily activities in a clinical laboratory . - Is a subject matter expert in assigned laboratory section - Supervises ... and departmental policies and procedures. - Ensures supplies and equipment are ordered and maintained to meet laboratory...impact the productivity, function and future direction of the laboratory . - Oversees the new procedures, lab … more
- Takeda Pharmaceuticals (Lexington, MA)
- …Coordinate with vendors. + Support regulatory inspections of Takeda as a subject matter expert . + Work with lab personnel to ensure shared understanding ... end-user questions and assistance resolving usage issues. + Support validation activities for ongoing projects. + Perform configuration to...act as an Subject Matter Expert and technical team member in lab … more