- Cipla (Hauppauge, NY)
- …reviews, prioritizes, and promptly responds to MFG and QA equipment qualification/ system validation and support requests. Maintains a positive relationship ... Description for Validation Engineer Role Summary The purpose of the Validation Engineeris toensure that products, equipment, and systems meet all applicable… more
- Insmed Incorporated (San Diego, CA)
- …Provide strategic leadership and decision making on CSV strategy Develop risk-based validation strategies for system implementation and changes following CSV ... Preferred Skills, Experience and Education): 7+ years' hands-on experience in a validation role with responsibility for computer systems specifically LIMS,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …technical studies, and any associated documentation in support of computer systems validation , equipment, utilities, and facility qualification, process ... and data integrity.Key ResponsibilitiesProvide quality and compliance oversight for computer systems validation , process validation , equipment, utilities,… 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...experience in generic pharmaceutical manufacturing. Technical Knowledge and Computer Systems Skills Excellent communication skills, drive, and sense of… 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
- ValSource, Inc. (Durham, NC)
- …and sterilization validation of manufacturing equipment. Experience with cleaning validation , process and utility systems validation , laboratory ... Validation Specialist / Validation Engineer /... (CQV) of Pharmaceutical and Biotech GMP manufacturing facility systems and equipment. Responsibilities are expected to include but… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Validation Lifecycle & Technical Lead as part of the Global MSAT team based ... MSAT organization. This individual will be responsible to support global process validation activities in support of the commercial Carvykti program both within… more
- Cipla (Hauppauge, NY)
- …to departmental SOPs, periodic review and reporting of the environmental monitoring system . Generate, review, approve and maintain Validation Master Plan and ... working outside of Cipla's US Subsidiaries or Affiliates. Job Title : QA Validation FLSA Classification : Professional, Exempt Work Location : Unit 1, Hauppauge, NY… more
- Houston Methodist West Hospital (Houston, TX)
- …timely manner. Serves as an educational resource for unit competency and validation procedures that are applicable to role. Contributes towards improvement of ... medication lists, treatments and procedures as determined by skills, training and validation (ie, vital signs, 12 Lead EKG, phlebotomy, ultrasound-guided IV catheter… more
- Middlesex Health (Bristol, CT)
- …up-to-date cancer registry, ensuring comprehensive and timely data entry Perform data validation and quality checks to ensure completeness and consistency of the ... care planning. Stay current with changes in tumor registry standards, coding systems (eg, ICD-10, AJCC staging), and cancer care practices. Participate in… more
- Cipla (Hauppauge, NY)
- …IT Manufacturing, Packaging and WH Systems support including IT administration, Systems Validation , PLC Validation , Maintain Infrastructure & Security ... end business processes to have the capability to propose system changes, process transformations in line with the evolving...and RA Systems support including IT administration, Systems Validation , Instrument Software Validation ,… more
- ValSource, Inc. (Rahway, NJ)
- … validation is desirable. Working knowledge of process automation and computer system validation concepts, GAMP methodologies, 21 CFR Part 11 compliance and ... qualification, validation of Pharmaceutical and Biotech GMP manufacturing facility systems and equipment. Validation Execution: Field Execute and oversee… more
- Aequor (Fort Worth, TX)
- …- Collaborate with QA and IT teams to implement and maintain Computer System Validation (CSV) and Computer Software Assurance (CSA) protocols. - Troubleshoot ... data integrity, regulatory compliance, and operational efficiency across our lab systems . ️ Key Responsibilities - Perform routine and scheduled calibrations of… more
- Insmed Incorporated (NJ)
- …control, periodic reviews, and audit trail reviews.What You'll Do: Develop risk-based validation strategies for system implementation and changes following CSV ... day-to-day operations of the CSV function including managing CSV system folders in the CSV SharePoint site, managing CSV...process) Who You Are:5+ years' experience in a management validation role with responsibility for computer systems … more
- Merck & Co. (Rahway, NJ)
- Job DescriptionDirector, Packaging Shipping Systems (Logistics and Distribution Technology)Reporting into the Director Packaging Distribution, Components and ... Systems COE, the Director, Global Distribution Engineering and Technology,...for shock and vibration as well as thermal protection system testing and qualification and leading execution of qualification… 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
- Merck & Co. (Rahway, NJ)
- …Director Packaging Technical Operations the Director Packaging Distribution, Components and Systems Center of Excellence (COE) is responsible and accountable for ... molecule bulk and primary packaging components and packaging master data and systems .The Packaging Technical Operations organization aims to be an industry leader in… more
- Christus Health (Irving, TX)
- …resolution. Follows strict change management processes ensuring proper approval, testing, and validation of system changes. Reviews and provides feedback on ... Description Summary: The Application System Analyst Senior serves as a liaison between...assigned applications in a timely and high-quality manner. The Systems Analyst Senior will provide application support and optimization.… more
- ValSource, Inc. (Worcester, MA)
- …within Pharmaceutical and Biotech GMP manufacturing facilities. This includes systems and equipment used in these environments. Responsibilities include, but ... with representatives from Process Engineering, Automation, Commissioning, Qualification & Validation (CQV) and others to drive projects through capital management… 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
