- 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, ... a key team member. \tProvide guidance and support to ensure Insmed computerized systems are deployed following lifecycle management and remain in a validated state… 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
- Aequor (San Diego, CA)
- …or related field.A minimum of 7 to 8 years of experience in computer systems validation in the pharmaceutical industry, including at least 2 years ... Position Summary:Responsible for planning, writing, implementing and reviewing computer system validation (CSV) protocols of GxP computerized systems .Serve as… more
- Insmed Incorporated (NJ)
- …leader to oversee cybersecurity operations, enterprise risk management, and Computer Systems Validation (CSV) program. This role will manage cross-functional ... and protect sensitive patient and research data.Demonstrated experience leading a Computer Systems Validation team in a regulated (pharmaceutical, biotech, or… more
- ValSource, Inc. (Rahway, NJ)
- …qualification, validation of Pharmaceutical and Biotech GMP manufacturing facility systems and equipment. Validation Execution: Field Execute and oversee ... with project management, good documentation practices, cGMP, & FDA validation methods and systems , ability to read...practices, cGMP, & FDA validation methods and systems , ability to read engineering documents, set priorities, and… 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 ... Cipla support functions and vendors / partners. This role will perform IT Systems Support including Systems Implementation, Validation , Administration etc.,… more
- Formation Bio (New York, NY)
- …Good Clinical Practices (GCP), Good Pharmacovigilance Practices (GPV) and Computer Systems Validation (CSV).The primary responsibilities for the Vice President ... there is a substantial component of oversight for the computer systems validation . The implementation of the QA strategy will involve leadership and… 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)
- …working outside of Cipla's US Subsidiaries or Affiliates. Job Title : QA Validation FLSA Classification : Professional, Exempt Work Location : Unit 1, Hauppauge, NY ... 8:30AM - 5:00PM (may vary based on business needs) Reports To : QA Validation Manager Salary Range: $68,000 - $74,600 Purpose: The incumbent to this role performs… more
- Insmed Incorporated (NJ)
- …operational support like change controls, release management, and reviews of validated systems . Author CSV Documents ( Validation Plans and Summary Reports) ... Skills, Experience and Education): 3+ years' hands on experience in a validation role with responsibility for computer systems specifically LIMS, Empower,… more
- Insmed Incorporated (NJ)
- …Annex 11, ICH Harmonized Guideline Good Clinical Practice (GCP) E6(R3), Computerized Systems Used in Clinical Trials, Computer System Validation , Quality ... or San Diego location. The Sr. Quality Engineer, Digital Systems Quality Assurance (QA), is responsible for providing quality...other GxP areas, with a focus on data integrity, validation , and inspection readiness. The Sr. Quality Engineer will… more
- Northrop Grumman (CA)
- …knowledge of systems engineering disciplines such as: Requirements Development, Systems Architecture and Design, Requirements Validation and Verification. An ... our employees have incredible opportunities to work on revolutionary systems that impact people's lives around the world today,...had a hand in that." At Northrop Grumman Aeronautics Systems and in Survivability Engineering, that could be Your… more
- Eisai, Inc (Tampa, FL)
- …area Strong analytical skills and report writing skills Experience with GxP systems including computer system validation and associated regulations, recommended. ... Ability to Travel (approximately 20%) Candidates near Eisai's NJ/PA location will be preferred. For candidates near an Eisai location, Remote Work Arrangement will consist of 2-4 days in office (Nutley/Exton) per month and 1-2 audits quarterly; remote audits,… more
- Insmed Incorporated (NJ)
- …and creative solutions to overcome process development obstacles.Working knowledge of quality systems , Quality by Design, validation principles for product and ... manufacturing processes, engineering design, and statistical process control fundamentals.Solid understanding of GLPs and cGMPs during pharmaceutical development and commercial manufacturing.Strong interpersonal skills and the ability to work in a fast paced,… more
- Cipla (Hauppauge, NY)
- …test results, material lot numbers) is captured accurately and completely. Oversee the validation of IT systems used in manufacturing processes, ensuring ... (DPI), you will ensure the integrity, compliance, and performance of IT systems , contributing directly to product quality and regulatory adherence. You will… more
- Merck & Co. (Lower Gwynedd, PA)
- …optimizations, and working with IT to deliver compliant solutions.- Assisting with validation of computerized systems .- Graph data modeling to simplify ... data analysis on data captured in Laboratory Information Management Systems (LIMS) within the regulated bioanalytical laboratory setting. Key responsibilities… 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
- Merck & Co. (Rahway, NJ)
- …and device product development, such as manufacturing process development and validation , design control, risk management, material and molding, design validation ... input(s).Lead establishment of test methodologies, including method development and validation , internally or externally, per design verification strategy.Lead strategy… more
- InterSources, Inc. (Richmond, VA)
- …quality standards and processes along with experience assisting in data reconciliation and validation checks across various systems . This must be reflected on ... during data profiling activities *Assist in data reconciliation and validation checks across various systems *Come up with initial proof of concepts for data… more
- Northrop Grumman (MD)
- …Northrop Grumman, our employees have incredible opportunities to work on revolutionary systems that impact people's lives around the world today, and for generations ... part of history, they're making history. Northrop Grumman Space Systems in Linthicum, MD is seeking a Principal or...modeling and simulation, integration and test, and verification and validation . As the Interfaces Lead Engineer , you will… more
Related Job Searches:
Computer Systems Validation,
Computer Systems Validation Engineer,
Computer Systems Validation Specialist,
Electro Mechanical Systems Validation,
Senior Computer Systems Validation,
Specialist Manufacturing Systems Validation,
Systems,
Systems Validation Engineer,
Systems Validation Manager,
Validation