- Syner-G BioPharma Group (Boston, MA)
- …impact. For more information, visit www.Synergbiopharma.com (Syner-G is seeking both Process and Validation Engineering Candidates) PROCESS ENGINEER ... requirements.Assist with the requirements specifications, design & development of process parameters, and the commissioning/ validation of manufacturing processes… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of computer systems validation , equipment, utilities, and facility qualification, process validation , shipping validation , and data integrity.Key ... ResponsibilitiesProvide quality and compliance oversight for computer systems validation , process validation , equipment, utilities, and facilities… more
- Cipla (Fall River, MA)
- …Track and manage periodic review. Develop strategies and documents for cleaning and process validation of API equipment and products in compliance with site ... and qualification of e-batch record & e-Log Book. Knowledge of cleaning validation and process validation . Knowledge in project handle with new equipment.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the global MSAT organization. This individual will be responsible to support global process validation activities in support of the commercial Carvykti program ... industry guidelines, specification & critical limitsDevelop and align a variety of process validation documentation templates ranging from control strategies to… more
- Cipla (Hauppauge, NY)
- …Job Overview Responsible for the coordination of supportive equipment and process validation activities such as testing, calibration, scale-up, engineering ... and maintain Validation Master Plan and summary reports and other Process validation lifecycle documents. Evaluate process validation projects to… more
- Endo International (St. Louis, MO)
- …+ Responsible for validation procedures, template creation and software validation process improvements + Reviews/approves validation deviation ... other sites involved with enterprise computer system software, Data Integrity, and equipment/ process validation needs. + Need to interact effectively with others… more
- ValSource, Inc. (Durham, NC)
- …and sterilization validation of manufacturing equipment. Experience with cleaning validation , process and utility systems validation , laboratory systems ... Validation Specialist / Validation Engineer /...Prior practical experience at a GMP facility in a Process Engineering, Facilities or Operations role with skills that… more
- Teleflex (Maple Grove, MN)
- …- Train and direct technicians in performing equipment qualifications, process characterization, test method validation execution, failure investigations. ... Sr. Principal Engineer, Verification & Validation , R&D **Date:** Nov 20, 2025 **Location:** Maple...characterization to allow selection of optimal design concepts and process technology. - Design the structure of flows of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …during routine manufacturing and protocol-driven activities such as tech transfer and process validation .Assist in the development of process , operational, ... in the treatment of multiple myeloma.Legend Biotech is seeking a Specialist, QA Process Excellence as part of the Quality team based in Raritan, NJ.Role OverviewThe… more
- Endo International (Hobart, NY)
- …**Production Processes Managed** Conducts reviews and approvals of equipment, product, and process validation documents and cleaning validation documents. ... processes. Ensures that processes comply with all cGMP regulations regarding process and cleaning validation . Completes exception investigations, identifies and… more
- BeOne Medicines (Pennington, NJ)
- …eBR, eLogs, etc.. + Technical Transfer experience including equipment qualification, process validation , and computer system validations. + Hands-on experience ... + Strong experience with process and equipment design, change management, process and equipment validation . + Direct project management experience required.… more
- Cordis (Miami Lakes, FL)
- …manufacturing processes from late design through commercialization. The engineer owns process characterization and validation -bringing up equipment and executing ... equipment through site acceptance and release. + Plan, author, and execute process /equipment validation (IQ/OQ/PQ) and test method validation (TMV) per 21… more
- Teleflex (Maple Grove, MN)
- …working in medical device catheter process development. - Expertise in process validation (IQ, OQ & PQ), experience with various production processing ... - Manage the planning, execution, and documentation of all process development & validation activities for new products based on, projected product volume,… more
- Endo International (Raleigh, NC)
- …Skills/Qualifications:_ _Other Skills:_ _Competencies:_ Understanding of GMPs (ICH Q7) and process validation Understanding of Six Sigma and Lean Manufacturing ... Activities include project scoping, operating requirements, process controls, process tolerances, alarm rationalization, and validation . + Prepares periodic… more
- Merck & Co. (Durham, NC)
- …areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation .The ... risk assessmentsAuthor or approve Change Control documentation for complex process , validation , analytical, equipment, facility/utility and/or automation… more
- ValSource, Inc. (Rahway, NJ)
- …expertise in the validation of a variety of utility, facility, and process equipment. Develop and maintain project schedules, ensuring timely completion of all ... process support systems, bioprocess manufacturing systems, packaging equipment, and process and cleaning validation is desirable. Working knowledge of … more
- Ralliant (Chandler, AZ)
- …full lifecycle of supplier quality management, from technical qualification and ** process validation ** to performance management and strategic development. This ... supplier inspection methods are capable and appropriate. + **Supplier Qualification & Process Validation :** Lead the qualification of new suppliers, focusing on… more
- Teleflex (Chelmsford, MA)
- …and process quality throughout the product lifecycle, with emphasis on process validation , test method validation , regulatory compliance, and quality ... R&R, basic DOE). - Basic understanding of manufacturing controls and process validation . - Ability to execute tasks independently and participate in… more
- WuXi AppTec (Middletown, DE)
- …support manufacturing and packaging operations, and will provide analytical support for process validation , cleaning validation , and packaging verification. ... stability studies, and raw materials. - Provide technical support for process validation , cleaning validation , and packaging verification activities. -… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …cell therapy processes, manage equipment qualification strategy, and support process validation activities for cell therapy platforms.Work cross-functionally ... process development, FATs, SATs, and IQ/OQ/PQ testing.Ensure successful manufacturing process comparability and process validation runs by assessing… more
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