- Exela Pharma Sciences, LLC (Lenoir, NC)
- …root cause analysis through SWOT, FMEA, etc.Serve as Quality subject matter expert concerning Engineering / Validation activities.Represent the company during ... Quality review/approval of CMMS asset records.Perform Quality review/approval of equipment/instrumentation/ process validation protocols and summary reports.Perform Quality… 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
- 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
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Automation Engineering (Auto Eng) Team within the Pharmaceutical Operations Engineering (POE) Department is seeking an experienced Automation ... Engineer, you will play a crucial role in supporting the process automation systems within clinical manufacturing.-The Automation Specialist - Engineering… more
- Merck & Co. (Durham, NC)
- …development and implementation of corrective actions.Over time, become a subject matter expert (SME) in specific process steps, automation technology platforms, ... Technician is a member of the Automation team responsible for the support of process control systems used in manufacturing operations located in Durham, NC.- We use… 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
- 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
- Regeneron Pharmaceuticals (East Greenbush, NY)
- … Sciences Drug Product Engineering department. This role is responsible for process controls and process validation for labelled drug product (LDP) ... & Drug Product Engineering departments through design transfer, technology transfer, process validation , regulatory filing, and lifecycle management. As a … more
- Bristol Myers Squibb (Bothell, WA)
- …of aseptic processes and environmental control systems. The Senior Engineer I, Validation supports airflow visualization study (AVS), aseptic process simulation ... EU GMP Annex 1 principles. + Acts as a validation Subject Matter Expert (SME) providing support...Relationship** This position will report to the Associate Director| Validation , Engineering & Technology (VET), MSAT **Qualifications**… more
- Kelly Services (Juncos, PR)
- …_In this role you'll be responsible for provides and/or directs the technical validation engineering support of process and/or equipment upgrades, ... validation issues. + Applies advanced and diverse validation engineering principles to the design and...to the design and implementation of major system or process modifications and/or capital projects. + Develops, organizes, analyzes… more
- Takeda Pharmaceuticals (Boston, MA)
- … validation strategy to the site and global projects. You will have engineering validation oversight and engineering validation signatory ... protocols and material for each activity. Guide peers in Validation and Engineering Departments to use statistically...is required. Must be considered a proficient Subject Matter Expert (SME) in all validation elements. +… more
- Takeda Pharmaceuticals (Social Circle, GA)
- …+ Sterilization validation + Materials validation + Process validation You will provide technical subject matter expert (SME) support to change ... and/or validation studies and report to the Engineering Validation Manager at our location in...process teams. **Minimum Requirements/Qualifications** + Bachelors degree in Engineering discipline required. Minimum 7 years validation … more
- Amgen (Holly Springs, NC)
- …will do** Let's do this! Let's change the world! In this vital role the Engineer- Validation will serve as a subject matter expert (SME) and support the ... validation outputs for commissioning and qualification of manufacturing process equipment. + Supply cleaning/sterilization validation support including… more
- Takeda Pharmaceuticals (Social Circle, GA)
- …Sterilization validation + Materials validation + Process validation Provide technical subject matter expert (SME) support to change controls, ... and regulatory agency inspections as a representative of the Engineering Validation team, as required. + Support...in the following applicable areas: Sterilization and aseptic processing validation . + Process and utility systems … more
- Takeda Pharmaceuticals (Social Circle, GA)
- …, Sterilization validation , Materials validation , and Process validation . Provide technical subject matter expert (SME) support to change controls, ... and regulatory agency inspections as a representative of the Engineering Validation team, as required. + Support...Sterilization and aseptic processing validation . + Cleaning validation of manufacturing equipment. + Process and… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …the analysis process and build improved efficiency. + Manage the validation system from a Quality Assurance perspective to ensure quality and compliance ... + Provide hands-on review and subject matter expertise of Validation lifecycle documentation including Process Design Documents,...A minimum of a Bachelor-s degree in Science or Engineering or associated fields is required Experience : +… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …related experience, preferably in the medical device industry related to process /quality engineering . + Viewed as an expert in the quality field. + ... existing products and processes + Leads the development and maintenance of Master Validation Plans + Monitors product and process performance metrics and acts… more
- Danaher Corporation (Muskegon, MI)
- …health. We are looking for a Validation Engineer to work with our expert engineering teams to support the multiyear construction, startup activities and then ... experience in ISO9001 and 13485 Manufacturing) with a preferred 3 years of validation or quality engineering /assurance experience + Familiar with Quality Systems… more
- Kelly Services (West Hills, CA)
- …departments as needed. + Liaise between support organizations, Microbiology, Quality, Engineering , Validation , Regulatory Affairs, Process Development, etc. ... may be required as necessary. 100% on-site **Responsibilities:** + Support the Quality Engineering group with documentation and validation needs. + Draft URS… more
- Insight Global (Wilson, NC)
- …. Skills and Requirements Bachelor's degree in science or engineering (STEM) 8+ years of equipment validation exp ... Job Description The Principal Validation Engineer plays a pivotal role as a...Engineer plays a pivotal role as a subject matter expert within manufacturing operations, fostering collaboration across quality, regulatory,… more
