- Legend Biotech USA, Inc. (Raritan, NJ)
- …systems validation , equipment , utilities, and facility qualification, process validation , shipping validation , and data integrity.Key ... Responsibilities Provide quality and compliance oversight for computer systems validation , process validation , equipment...and supported every step of the way. Highlights include medical , dental, and vision insurance as well as a… more
- Repligen (Rancho Dominguez, CA)
- …Matter Expert for TFF and other bioprocessing manufacturing systems. Lead projects in equipment design, tech transfer, process validation , and facility ... manufacturing is highly desirable. Hands-on experience with: Tangential Flow Filtration (TFF) Process validation and equipment qualification Tech transfer… more
- Merck & Co. (Rahway, NJ)
- …AR&D network. The role oversees and supports the onboarding, qualification, validation , and routine maintenance of analytical equipment and instrumentation ... Validation (CSV), Data Analysis, Diversity and Inclusion (D&I), Equipment Maintenance, Experimentation, GMP Compliance, GMP Environments, Inventory Management,… more
- Merck & Co. (Rahway, NJ)
- …approve GMP procedures and documentation, with an emphasis on Qualification and Validation plans around equipment , critical utilities, and computer systems.- ... Execute qualifications, validation , commissioning, and decommissioning activities.- Prepare Validation plans and annual reports around critical equipment and… more
- Eisai, Inc (Exton, PA)
- …and CIP/SIP operations. Knowledgeable in process development, technology transfer, equipment scale-up, equipment validation , and facility startup. ... Supervise change-over activities. Be responsible for ensuring routine suite and equipment maintenance, calibration, and validation with appropriate internal… more
- Lundbeck (Bothell, WA)
- …and advancement of a growing biologics pipeline in collaboration with our Copenhagen-based Process Science & Validation Team. The Lu-SBP team leads and supports ... Lundbeck Seattle BioPharmaceuticals (Lu-SBP), located in Bothell, Washington, is the Process Development Center of Excellence for Biologics within the global… more
- Merck & Co. (Rahway, NJ)
- …this area, you will partake in medical device assembly and process development using semi-automated and automated equipment , conduct functional testing, ... designs and develops benchtop/low-volume to high-volume clinical and commercial assembly equipment and processes for medical devices/drug delivery systems.… more
- Merck & Co. (Rahway, NJ)
- …NDAs.Exposure to project / engineering work process and deliverables (eg equipment fabrication, FAT, SAT, Validation etc.)Must be innovative and drive new ... in equipment Fabrication, FAT/SAT, start-up, qualification and/or validation is preferredFill/finish process scale-up, Drug Delivery and/or… more
- Tris Pharma (Monmouth Junction, NJ)
- …Scientist II, under supervision, performs laboratory analyses of raw materials, in process (IP), finished products (FP) and stability (ST) samples and executes ... field and minimum 4 years experience in analytical/method development or method validation in the pharmaceutical or biotechnology field ORMasters degree in Chemistry… more
- Merck & Co. (Rahway, NJ)
- …of project / engineering work process and deliverables (eg, equipment fabrication, FAT, SAT, qualification / validation )Current Employees apply HERE ... -Our development teams ensure robust composition, primary packaging/device, and process selection through deep fundamental understanding and characterization such… more
- Merck & Co. (Rahway, NJ)
- …Independently performs audits of batch documentation, data, information, procedures, equipment and systems, and/or facilities to ensure the compliance with ... -- Required Experience and Skills: Experience in the pharmaceutical, biotechnology, chemical, medical device, or closely related industry.- Experience in one or more… more
- Merck & Co. (Rahway, NJ)
- …candidate will have strong technical expertise in HVAC design, maintenance, and validation within a highly regulated environment, combined with leadership skills to ... functionality of HVAC systems and familiarity with all utility generation equipment (eg electrical distribution, clean utilities, etc)Good oral and written… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …combined experience in commercial scale cGMP manufacturing, operations management, tech transfer, process and equipment validation or quality management; ... they feel valued and supported every step of the way. Highlights include medical , dental, and vision insurance as well as a 401(k)-retirement plan with company… more
- Catalent Pharma Solutions (Kansas City, MO)
- …equipment using lean six sigma methodologies. Authors and executes equipment / process /computer/facility validation reports and protocols. Performs periodic ... is required + At least two years of GMP process , equipment and/or facility engineering validation...match + Company match on donations to organizations + Medical , dental and vision benefits effective day one of… more
- Jabil (Hunt Valley, MD)
- …and diverse communities around the globe. JOB SUMMARY Assists Product Validation Engineers in the development of test solution/proposals. Also, provides actual ... validation support, and continuously works to improve core competency....test reports. | Responsible for the planning of tools, equipment , test procedures, methodologies and benchmarking for all new… more
- BioBridge Global (San Antonio, TX)
- …Manage and maintain requirements documentation throughout the development of the validation process . Create and maintain requirements traceability matrix (RTM). ... areas: Technical writing, validation documentation drafting, assay validation , equipment validation , procedural ...to identify and solve issues that arise during the validation process . Must possess data analysis and… more
- Novo Nordisk (Bloomington, IN)
- …installation / operational qualifications and requalification's on process equipment and utilities + Revise validation documents including protocols ... 14 weeks paid parental & 6 weeks paid family medical leave + Free access to Novo Nordisk-marketed pharmaceutical...computer system validation , and process validation , and be able to integrate equipment … more
- Harmac Medical Products (Buffalo, NY)
- …support to all Harmac Medical Product Facilities in the Computerized System Validation Process . This is a full time, salaried (exempt) position. This is ... Software Validation Engineer About the Organization Harmac Medical...to evaluate computerized systems based on applicability, functionality, and process and product safety. They will support management and… more
- Abeona (Cleveland, OH)
- …etc.) + 8+ years of experience in an Equipment and/or Process Validation Engineering role within a pharmaceutical or medical device company + Must be ... is compliant with validation requirements and policies. Provides facility, equipment and process qualification technical expertise. Author validation … more
- Catalent Pharma Solutions (Harmans, MD)
- …electronic data integrity. + Review and approve Protocols and Summary Reports for Process Validation such as PPQ's, Engineering studies, Cleaning Validation , ... **Lead Specialist, QA Validation & Engineering** Catalent Pharma Solutions is looking...product. This position will provide continuous improvement support to process , equipment , utilities and computer systems and… more
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