- Insmed Incorporated (San Diego, CA)
- …hands-on experience in a validation role with responsibility for computer systems specifically LIMS, eTMF/CTMS, and other Clinical/Manufacturing systems ... Provide strategic leadership and decision making on CSV strategy Develop risk-based validation strategies for system implementation and changes following CSV… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …risk assessments, technical studies, and any associated documentation in support of computer systems validation , equipment, utilities, and facility ... validation , and data integrity.Key ResponsibilitiesProvide quality and compliance oversight for computer systems validation , process validation ,… more
- ValSource, Inc. (Rahway, NJ)
- …and cleaning validation is desirable. Working knowledge of process automation and computer system validation concepts, GAMP methodologies, 21 CFR Part 11 ... qualification, validation of Pharmaceutical and Biotech GMP manufacturing facility systems and equipment. Validation Execution: Field Execute and oversee… more
- Aequor (Fort Worth, TX)
- …and existing equipment. - Collaborate with QA and IT teams to implement and maintain Computer System Validation (CSV) and Computer Software Assurance ... data integrity, regulatory compliance, and operational efficiency across our lab systems . ️ Key Responsibilities - Perform routine and scheduled calibrations of… more
- Insmed Incorporated (NJ)
- …seeking an experienced leader to oversee cybersecurity operations, enterprise risk management, and Computer Systems Validation (CSV) program. This role will ... landscape and protect sensitive patient and research data.Demonstrated experience leading a Computer Systems Validation team in a regulated (pharmaceutical,… more
- Formation Bio (New York, NY)
- …Practices (GLP), Good Clinical Practices (GCP), Good Pharmacovigilance Practices (GPV) and Computer Systems Validation (CSV).The primary responsibilities for ... development organization, there is a substantial component of oversight for the computer systems validation . The implementation of the QA strategy will… more
- Cipla (Fall River, MA)
- …documents. Preparation of qualification and validation documents of equipment and computer system . Preparation and qualification of e-batch record & e-Log ... 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,… more
- Syner-G BioPharma Group (Boston, MA)
- …production systems , with a concentration on computerized equipment and systems validation .Report writing experience for IQ, OQ, PQ, and CSV.Knowledge, ... (FAT, SAT, IOQ, PQ) for cleaning, shipping, facilities, utilities, systems , equipment, and processes for (re)qualification/(re)verification.Support validation … more
- Cipla (Hauppauge, NY)
- …(DPI, MDI, oral solid or Injectables preferred). Technical Knowledge and Computer Systems Skills Effective interpersonal relationship skills and the ... to departmental SOPs, periodic review and reporting of the environmental monitoring system . Generate, review, approve and maintain Validation Master Plan and… more
- Houston Methodist West Hospital (Houston, TX)
- …the department and interprofessional health care team as appropriate Possesses competent computer knowledge. Operates multiple computer systems including ... timely manner. Serves as an educational resource for unit competency and validation procedures that are applicable to role. Contributes towards improvement of… more
- Insmed Incorporated (NJ)
- …years' experience in a management validation role with responsibility for computer systems specifically eTMF, CTMS, EDC, IRT, eCOA/ePRO and other ... reviews, and audit trail reviews.What You'll Do: Develop risk-based validation strategies for system implementation and changes...Clinical/Manufacturing systems .Minimum of a Bachelor's Degree in Computer … more
- Cipla (Fall River, MA)
- …IT Manufacturing, Packaging and WH Systems support including IT administration, Systems Validation , PLC. SAP Skills in Production, WH, Packaging and Quality ... and vendors / partners. This role will perform IT Systems Support including Systems Implementation, Validation...end business processes to have the capability to propose system changes, process transformations in line with the evolving… more
- AUROBINDO (Durham, NC)
- …in risk assessments and impact analysis for system changes.Support validation activities including IQ/OQ/PQ for IT systems .Maintain QA documentation in ... systems .Excellent documentation and communication skills.Familiarity with risk-based validation approaches.Education & ExperienceBachelor's Degree in Computer … more
- Fresenius Medical Care (Georgetown, KY)
- …care as per the disease management agreement, including initial and ongoing validation of member eligibility. Facilitate timely workup of patients for access ... company. Maintains current knowledge of disease management software and systems as pertinent. STAFF: Responsible for implementation of FMS...for the integrity and safety of the facility water system . Must be knowledgeable in the operation of all… more
- Insmed Incorporated (NJ)
- …hands on experience in a validation role with responsibility for computer systems specifically LIMS, Empower, BMRAM, Chromeleon, environmental monitoring ... operational support like change controls, release management, and reviews of validated systems . Author CSV Documents ( Validation Plans and Summary Reports)… 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
- Insmed Incorporated (NJ)
- …business, and IT infrastructurePrevious experience managing computer systems in pharmaceutical environmentsKnowledge of System Operational procedures ... role serves as the IT System Owner for the Learning Management System and compliance IT systems , which includes supporting GxP-regulated applications, while… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …environment. This role will ensure compliance within the document management system , document storage and retention, and document issuance and reconciliation.Shift ... documents to ensure compliance with global and site procedures.Support Document Management system users with workflow handling and electronic system usage.Manage… more
- Cipla (Hauppauge, NY)
- …generated during the production such as batch manufacturing records and validation protocols. Ensure and compliance with safety, quality, productivity, and ... execution of bio-batches (abbreviated new drug applications - ANDA) and validation batches. Effective implementation of current good manufacturing practices (cGMP)… more
- Cipla (Fall River, MA)
- …candidates with experience in generic pharmaceutical manufacturing. Technical Knowledge and Computer Systems Skills Excellent communication skills, drive, and ... procedures. Develop strategies and documents for cleaning and process validation of equipment and products in compliance with site...sense of urgency Excellent computer skills, specifically Microsoft Office Suite. Solid organizational and… more
