computer system validation csv manager Jobs

21 - 40 of 67 Jobs

CSV EngineerJob Title - CSV Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

•

Nutley, New Jersey, USA

Full-time

Job Description: Looking for someone who has done Validation.Google Cloud Platform and CSV. Must understand the business of clinical. We are seeking a versatile professional with the ability to review documents meticulously and support the creation of validation deliverables as needed. The ideal candidate will thrive in a challenging environment and possess the skills to effectively communicate the importance of validation processes to stakeholders outside the validation team. Responsibilities:

Sr. Validation Engineer (CSV)Job Title - Sr. Validation Engineer (CSV)

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

•

California, USA

Full-time

Responsibilities: Create and execute Computer System Validation (CSV) deliverables (Validation Plans, Protocols, Reports, Trace Matrices, SOPs). Collaborate with Business Users, System Owners, IT teams, and Analysts to define validation requirements. Provide leadership and training in validation activities. Generate IQ/OQ/PQ protocols using Good Documentation Practices (GDP). Ensure compliance with quality system elements for computer systems/software testing. Perform gap assessments and remedia

IT infrastructure CSV ConsultantJob Title - IT infrastructure CSV Consultant

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

•

Cranbury, New Jersey, USA

Full-time

Responsibilities: We are seeking a Validation & IT Systems Specialist to join our dynamic team. This role combines expertise in validation and computer system validation (CSV) with IT administrative support for regulated systems and applications. IT Infrastructure guy who has worked in the Pharma industry, having 21 CFR part 11 exp. Provide administrative support for IT systems and applications, ensuring smooth operations in a regulated environment. Manage system configurations, troubleshooting

Sr. Software Quality Engineer (CSV)Job Title - Sr. Software Quality Engineer (CSV)

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

•

Texas, USA

Full-time

Responsibilities: Lead computer software validation (CSV) project planning activities including the creation or updates to URS, SDS and RTM documents. Create, review and approve software validation documentation. Create and execute qualification protocols and document reports; review and approve software test scripts and code reviews. Review and approve internal and vendor software packages and test documentation. Prioritize and plan all assigned projects for the software validation departm

CSV EngineerJob Title - CSV Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

•

Massachusetts, USA

Full-time

Job Overview: Our client seeking an experienced CSV / IT GxP Consultant. This role will focus on ensuring the alignment of internal policies with federal and state regulations, improving our Computer System Validation (CSV) processes, and enhancing third-party vendor compliance. The position will also involve developing and implementing SOPs, as well as managing data privacy and retention policies. The ideal candidate will have experience in GxP regulations and a strong understanding of IT proce

CSV EngineerJob Title - CSV Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

•

Portsmouth, New Hampshire, USA

Full-time

Responsibilities: Hands-on experience in Implementation & Validation of various computerized systems like MES (Syncade) & PLC (COTS). Strong knowledge of Software Development Lifecycle (SDLC), including 21CFR part 11/Annex 11, Data Integrity and computerized system validation requirements. Experience working independently as well as in a team-oriented, collaborative environment is essential. Author and Execute CSV life cycle documentation. Requirements: CSV experience of 4+ years. Ex

Central Automation Engineer- CSV / Data IntegrityJob Title - Central Automation Engineer- CSV / Data Integrity

Eli Lilly and CompanyCompany Name - Eli Lilly and Company

•

Indianapolis, Indiana, USA

Full-time

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined

MES EngineerJob Title - MES Engineer

Sunrise Systems, Inc.Company Name - Sunrise Systems, Inc.

•

Summit, New Jersey, USA

Contract

Job Title: MES Engineer Job ID: 25-07988 Location: Summit, NJ Duration: 06 Month s Contract on W2 Candidates must be onsite 50% of the time at either Summit West, Giralda Farms, Princeton Pike, Lawrenceville, or New Brunswick. Must Have List4+ years of Computer System Validation (CSV) experience in regulated pharmaceutical and biotech environments, with strong knowledge of GAMP 5, 21 CFR Part 11, and Computer Software Assurance (CSA) principles.3+ years of hands on MES experience with Emerson S

Validation Lead with SAPJob Title - Validation Lead with SAP

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

•

South Plainfield, New Jersey, USA

Full-time

Responsibilities: To create| assign and track the project [module] work plans for delivery and provide technical guidance for work completion. Ensure process improvement and compliance in the assigned module| and participate in technical discussions/review. Create work plans| monitor and track the work schedule for on time delivery as per the defined quality standards. Prepare and submit status reports for minimizing exposure and risks on the project or closure of escalations. Develop and guide

Data Integrity QA Validation EngineerJob Title - Data Integrity QA Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

•

Rensselaer, New York, USA

Full-time

Responsibilities: Participate on teams of internal resources in delivery of CSV projects. Author functional requirements specifications that are complete, accurate, and testable. Author system Risk Assessments, 21 CFR 11 Assessments, and Annex 11 Assessments. Author Validation Plans and Validation Reports. Author validation and verification testing protocols/scripts (i.e., IQ, OQ, PQ) and Trace Matrices. Experience in validation at least two of these computer system categories: automation contro

CSV EngineerJob Title - CSV Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

•

New Brunswick, New Jersey, USA

Full-time

Job description: We're seeking a Senior MES Engineer/Validation Lead to take ownership of computer system validation activities for Manufacturing Execution Systems (MES) supporting cell therapy manufacturing. This role is ideal for someone with a strong IT/Computer Science foundation and 3 years of hands-on experience in the pharma/biotech industry. You'll partner with QA, Business, and IT teams to ensure compliant and efficient deployment of MES & Recipes solutions. Responsibilities: Lead end

CSV Automation Engineer (R3)Job Title - CSV Automation Engineer (R3)

Eli Lilly and CompanyCompany Name - Eli Lilly and Company

•

Branchburg, New Jersey, USA

Full-time

CSV EngineerJob Title - CSV Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

•

Los Angeles, California, USA

Full-time

Responsibilities: Lead the development and approval of validation documentation, risk assessments, etc. Work with project teams to determine which elements should be validated and conduct impact assessment of proposed changed to computerized systems. Generate, obtain approvals, and execute validation deliverables for computerized systems and relevant infrastructure, including Validation Plans, Requirements Specification, Risk Assessments, Installation/Operational Qualifications, Traceability M

CSV EngineerJob Title - CSV Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

•

Jacksonville, Florida, USA

Full-time

CSV Validation EngineerJob Title - CSV Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

•

Rockville, Maryland, USA

Full-time

Responsibilities: Our client is currently in the process of starting up a clinical cell therapy site with clean rooms. They are in the commissioning phase and validating documentation and processes for the utilities, facilities, computer systems, and cleanroom environments to meet the requirements for cell-based therapies. The site will be designed to support the production of cell therapies, which necessitates adherence to GMP, regulatory compliance, and the implementation of validation and com

Commissioning & Qualification (C&Q) EngineerJob Title - Commissioning & Qualification (C&Q) Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

•

Harrisburg, Pennsylvania, USA

Full-time

Responsibilities: Develop and execute commissioning protocols (FAT, SAT, IQ, OQ and PQ) for equipment, systems, and facilities. Perform system startup, debugging, and initial testing of process and utility systems. Ensure that systems are installed and operating according to design specifications. Collaborate with engineering, manufacturing, and quality teams during equipment installation and commissioning. Review and verify system documentation, such as P&IDs, wiring diagrams, and datashee

System Engineer- Serialization Execution System Applications (SES)Job Title - System Engineer- Serialization Execution System Applications (SES)

Eli Lilly and CompanyCompany Name - Eli Lilly and Company

•

Indianapolis, Indiana, USA

Full-time

Validation EngineerJob Title - Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

•

Summit, New Jersey, USA

Full-time

Position Overview: The CSV Engineer supports the successful implementation of manufacturing and laboratory equipment and computerized systems at multi-use sites through interaction with internal customers and external service providers. The incumbent in this role, contributes to the completion of milestones associated with equipment qualification and systems validation. With minimum supervision and given general instructions, this individual carries out routine tasks, functions, and uses basi

IT Client Site Support ( NPHS Manufacturing)Job Title - IT Client Site Support ( NPHS Manufacturing)

Cardinal HealthCompany Name - Cardinal Health

•

Indianapolis, Indiana, USA

Full-time

Headquartered in Dublin, Ohio, Cardinal Health, Inc. (NYSE: CAH) is a global, integrated healthcare services and products company connecting patients, providers, payers, pharmacists and manufacturers for integrated care coordination and better patient management. Backed by nearly 100 years of experience, with more than 50,000 employees in nearly 60 countries, Cardinal Health ranks among the top 20 on the Fortune 500. Information Technology oversees the effective development, delivery, and opera

MES - Validation EngineerJob Title - MES - Validation Engineer

HAYSCompany Name - HAYS

•

Princeton, New Jersey, USA

Contract

MES - Validation Engineer - Contract - Princeton, NJ - $59.44 - $59.44/hr. The final salary or hourly wage, as applicable, paid to each candidate/applicant for this position is ultimately dependent on a variety of factors, including, but not limited to, the candidate's/applicant's qualifications, skills, and level of experience as well as the geographical location of the position. Applicants must be legally authorized to work in the United States. Sponsorship not available. Our client is seek