- Legend Biotech USA, Inc. (Raritan, NJ)
- …level position with responsibilities for providing quality oversight over the validation and qualification activities for equipment , systems, computer systems, ... studies, and any associated documentation in support of computer systems validation , equipment , utilities, and facility qualification, process validation… more
- Merck & Co. (Durham, NC)
- …in preparation for commercial production.- The selected candidate will participate in equipment validation , process validation , and GMP laboratory ... Specialist, Quality Control participates in a team of analysts in the development, validation , and routine testing for the BCG Product. The position will focus on… more
- Eisai, Inc (Exton, PA)
- …operation, 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in commercial scale cGMP manufacturing, operations management, tech transfer, process and equipment validation or quality management; with a preference for ... Cell/Gene Therapy experienceMinimum of 5 years of experience of progressive leadership roles in a cGMP operation, with prior Biologics and/or cell therapy operations experience preferred.Prior experience leading large multilevel teams.A history of developing… more
- Repligen (Rancho Dominguez, CA)
- …Expert for TFF and other bioprocessing manufacturing systems. Lead projects in equipment design, tech transfer, process validation , and facility upgrades. ... is highly desirable. Hands-on experience with: Tangential Flow Filtration (TFF) Process validation and equipment qualification Tech transfer between sites Data… more
- Merck & Co. (Durham, NC)
- …Author or approve Change Control documentation for complex process, validation , analytical, equipment , facility/utility and/or automation changes. Managing ... documentation associated with site commercialization efforts Participate in the equipment specification, selection/procurement, and qualification phases of vaccine capital… more
- Merck & Co. (Rahway, NJ)
- …INDs and NDAs.Exposure to project / engineering work process and deliverables (eg equipment fabrication, FAT, SAT, Validation etc.)Must be innovative and drive ... scientific staff from a budgetary and personnel decisions standpoint.Experience in equipment Fabrication, FAT/SAT, start-up, qualification and/or validation is… 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
- Actalent (Golden, CO)
- …to ensure proper equipment function. Engage in tablet manufacturing and oven equipment validation tasks. Essential Skills 4-7+ years of experience as a ... or medical device industries. Expertise in tablet manufacturing and oven equipment validation . Additional Skills & Qualifications Experience in highly… more
- Validation & Engineering Group Inc. (New Albany, OH)
- …to work under the highest ethics standards for the following position: Validation Specialist for Packaging Equipment Qualifications: Bachelor's Degree in Science ... Validation & Engineering Group, Inc. (V&EG) is a...medical device or biotechnology industries. Experience in biotech packaging equipment (Vial filling, Syringe Filling, Lyophilization, Isolators, and secondary… more
- PolyPeptide US (Torrance, CA)
- …pharmaceutical or biotech environment. Foundational understanding of process validation , equipment qualification (IQ/OQ/PQ), and pharmaceutical manufacturing ... processes. Skills & Competencies Technical Skills: Working knowledge of process validation and equipment qualification within a cGMP framework. Proficiency in… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …ELISA, UPLC) Completes routine equipment maintenance/calibration Supports equipment qualifications or method verification/ validation activities Participates ... of physical conditions including: noise, close proximity to moving parts and equipment , use of ladders, and exposure to chemicals; atmospheric conditions including:… more
- Johnson and Johnson (Danvers, MA)
- …(VMP), protocols (IQ/OQ/PQ), risk assessments, and final reports. Design and execute validation activities for new equipment , manufacturing lines, and process ... SME. Preferred Qualifications: Six Sigma or Lean certification. Experience with equipment and software validation (21 CFR Part 11 compliance). Familiarity… more
- Katalyst HealthCares and Life Sciences (San Mateo, CA)
- …validation activities. Responsible for executing qualification protocols for equipment , utilities, facilities, cleaning, and manufacturing processes with proper ... Responsible for providing technical input for the qualification and validation of laboratory equipment as well as...for the qualification and validation of laboratory equipment as well as facilities. Responsible for providing an… 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
- Novo Nordisk Inc. (West Lebanon, IN)
- …with coordinating fabrication, procurement, installation, engineering start-up, verification and validation activities of new equipment and systems. ... and weekend on call support as needed Technical requirements for Validation and of biopharmaceutical equipment , facilities and/or instrumentation preferred… more
- Syner-G BioPharma Group (San Diego, CA)
- …SAT, IOQ, PQ) for cleaning, shipping, facilities, utilities, systems, equipment , and processes for (re)qualification/(re)verification. Support validation ... working with FDA cGMP, FMEA, and Risk Analysis required. Validation expertise in Equipment , CSV, Method, and Process. Protocol generation experience of automated… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …and related issues Coordinate fabrication, procurement, installation, engineering start-up, and validation activities of new equipment and systems, including ... for the design and implementation of manufacturing processes, instrumentation, and equipment start-ups from the laboratory through manufacturing scale. This role… more
- Barry-Wehmiller Companies (Los Angeles, CA)
- …utilities, facility systems, process support systems, bioprocess manufacturing systems, packaging equipment , and process and cleaning validation is desirable. ... build a better world. Job Description: Client Development Lead, Validation and Regulatory Compliance (Design Group) Who You'll Work...you join Design Group as a Client Development Lead, Validation and Regulatory Compliance, you are joining a team… more
- PolyPeptide US (Torrance, CA)
- …Skills & Competencies Technical Skills: Working knowledge of cGMP regulations, equipment qualification, and validation practices. Proven experience in capital ... is responsible for supporting the design, implementation, and optimization of equipment , utilities, and facility systems within the manufacturing site. This role… more
