- Insmed Incorporated (San Diego, CA)
- …Preferred Skills, Experience and Education): 7+ years' hands-on experience in a validation role with responsibility for computer systems specifically LIMS, ... strategic leadership and decision making on CSV strategy Develop risk-based validation strategies for system implementation and changes following CSV SOPs and… more
- 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, ... assessments, technical studies, and any associated documentation in support of computer systems validation , equipment, utilities, and facility qualification,… more
- ValSource, Inc. (Rahway, NJ)
- …cleaning validation is desirable. Working knowledge of process automation and computer system validation concepts, GAMP methodologies, 21 CFR Part 11 ... our regions in the US. The Commissioning, Qualification & Validation (CQV) Project Manager will interface with our clients...which includes vessel spray coverage testing. Working on a computer to draft protocols, analyze data and write reports.… more
- Insmed Incorporated (NJ)
- …an experienced leader to oversee cybersecurity operations, enterprise risk management, and Computer Systems Validation (CSV) program. This role will manage ... and protect sensitive patient and research data.Demonstrated experience leading a Computer Systems Validation team in a regulated (pharmaceutical, biotech,… more
- Formation Bio (New York, NY)
- …that ensure Formation Bio and its vendor network comply with GXP, and Computer validation standards. Provide leadership and direction to the quality assurance ... (GLP), Good Clinical Practices (GCP), Good Pharmacovigilance Practices (GPV) and Computer Systems Validation (CSV).The primary responsibilities for the Vice… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …strongly preferred.Experience with Manufacturing Execution Systems (MES) design/development and validation is preferred.Experience with Computer System ... manufacturing and protocol-driven activities such as tech transfer and process validation .Assist in the development of process, operational, and quality improvements… more
- Cipla (Fall River, MA)
- …of qualification and validation documents. Preparation of qualification and validation documents of equipment and computer system. Preparation and ... Job Title : Mfg. Validation Engineer FLSA Classification : Professional, Exempt Work...with experience in generic pharmaceutical manufacturing. Technical Knowledge and Computer Systems Skills Excellent communication skills, drive, and sense… more
- Syner-G BioPharma Group (Boston, MA)
- …information, visit www.Synergbiopharma.com (Syner-G is seeking both Process and Validation Engineering Candidates) PROCESS ENGINEER POSITION OVERVIEW : Syner-G is ... specifications, design & development of process parameters, and the commissioning/ validation of manufacturing processes for compliance with quality and regulatory… more
- Cipla (Hauppauge, NY)
- …working outside of Cipla's US Subsidiaries or Affiliates. Job Title : QA Validation FLSA Classification : Professional, Exempt Work Location : Unit 1, Hauppauge, NY ... vary based on business needs) Reports To : QA Validation Manager Salary Range: $68,000 - $74,600 Purpose: The...pharmacy) or a related field. Must be proficient in computer skills and software applications such as Microsoft Office… more
- Insmed Incorporated (NJ)
- …the GxP IT CAB process) Who You Are:5+ years' experience in a management validation role with responsibility for computer systems specifically eTMF, CTMS, EDC, ... periodic reviews, and audit trail reviews.What You'll Do: Develop risk-based validation strategies for system implementation and changes following CSV SOPs and… more
- USAA (Plano, TX)
- …We are seeking a skilled individual to execute comprehensive model risk validation oversight for the lifecycle management of models. This includes conducting ... thorough model validation activities and ensuring adherence to written risk and...as Economics, Mathematics, Statistics, Actuarial Science, Data Science, Engineering, Computer Science, or a Related Field with Core Quantitative… more
- AUROBINDO (Durham, NC)
- …GxP systems.Excellent documentation and communication skills.Familiarity with risk-based validation approaches.Education & ExperienceBachelor's Degree in Computer ... company policies. This role involves planning, executing, and documenting validation activities for IT systems, laboratory instruments, and manufacturing… more
- Insmed Incorporated (NJ)
- …GxP system owners. Who You Are:3+ years' hands on experience in a validation role with responsibility for computer systems specifically LIMS, Empower, BMRAM, ... management, and reviews of validated systems. Author CSV Documents ( Validation Plans and Summary Reports) Assist/co-author requirements, testing, specification, and… more
- Merck & Co. (Rahway, NJ)
- …of product design and development; manufacturing process development, qualification, and validation ; and design control and risk management techniques to positively ... development programs ranging from concept generation/selection, development, verification, and validation to launch readiness:Lead the cross-functional Device Working Groups… more
- Aptyx (Charlotte, NC)
- …and reliability testing plans for catheter systems, including the development and validation of accurate in-vitro and in-vivo models and methods Develop pilot and ... for devices Assess feasibility of processes and support manufacturing with validation plans and time studies Support product manufacturing until the project… more
- BioAgilytix (San Diego, CA)
- …and metabolite profiling/ID. You'll guide a team of scientists through assay development, validation , and sample analysis under GxP, while also playing a key role in ... with clients to assure successful on time execution of assays, validation , and sample analysis under GxPs.Prioritizing tasks and managing schedules efficiently.Meet… more
- Cipla (Fall River, MA)
- …role will perform IT Systems Support including Systems Implementation, Validation , Administration etc., for Manufacturing, Packaging, Warehouse, Quality etc., IT ... Packaging and WH Systems support including IT administration, Systems Validation , PLC. SAP Skills in Production, WH, Packaging and...of sitting at a desk and working on a computer . Able to be able to wear personal protective… more
- Cipla (Fall River, MA)
- …approved and executed documents related to SOPs, batch records, validation and qualification protocols, specifications, training records, QMS related documents, ... the approved and executed documents related to SOPs, batch records, validation and qualification protocols, specifications, training records, QMS related documents,… more
- Takeda Pharmaceutical (Los Angeles, CA)
- …lifecycle implementation of LabWare changes-requirements, design, configuration, testing, validation , and deployment. Evaluate and implement LIMS functionalities and ... OOS/OOT rates, and turnaround time. Collaborate with QC, IT, Digital, Validation , Manufacturing, and Quality Systems on LIMS enhancements, integrations, and … more
- Cipla (Fall River, MA)
- …of approved procedures. Develop strategies and documents for cleaning and process validation of equipment and products in compliance with site SOPs and regulatory ... mitigate impact. Reviews document for accuracy and completeness. Defends the validation programs and strategies to customers and regulatory auditors. Performs weekly… more
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