Validation (CSV) Project Manager

Responsibilities: This position is responsible for leading and performing activities in support of creating and maintaining GxP (GMP, GCP, and GLP) quality and compliance environment for SAP S/4 HANA. This position is also responsible for monitoring Computer System validation (CSV) as well as compliance with GxP regulations and 21 CFR Part 11. Leads...

CSV Engineer Boston/Rhode Island Responsibilities: Draft and implement Quality System documentation designed to establish good validation practices within the organization. Author URS, FRS, Risk Assessments, Configuration specification, design specification and CSV test protocols and execute them in compliance with GDP guidelines and internal quality...

CSV role. SAP S4 system validation with Jira Xray CSV with SAP S4 system validation and Jira Xray

Role: CSV ConsultantJob Type: ContractLocation: New Jersey (Onsite)Need candidates on W2Job Description:Need candidate with CSV experience, Experience in SAP S4 system validation with Jira Xray, etc

Expertise in conducting Risk Assessment, ensuring compliance to Part 11, 820, GAMP guidelines, Security Assessment, Corrective and Preventive Actions (CAPA) Investigation, GxP (cGMP, GDP, GCP, GLP) suites and Standard Operating Procedures (SOP). Expertise in Developing and reviewing SDLC deliverables including Validation Master Plan (VMP), Requirement...

Responsibilities: Write technical documents associated with projects. Write engineering and design specifications (URS/FS/DS) and protocols (IQ/OQ/PQ/CSV) for facility and utility systems. Perform (hands on) field execution of commissioning and/or validation documentation. Reviewing equipment lists, instrument lists, drawings, specifications, and submittals...

The Sr. Software Validation Specialist role is an exempt level position with responsibilities for providing quality oversight over the validation and qualification activities for computer systems and processes to support both clinical and commercial requirements in a GXP environment. This role with develop CSV gap assessments and remediation plan with an...

Job Description The Sr. Software Validation Specialist role is an exempt level position with responsibilities for providing quality oversight over the validation and qualification activities for computer systems and processes to support both clinical and commercial requirements in a GXP environment. This role with develop CSV gap assessments and remediation...

uniQure is dedicated to bringing therapies for unmet medical needs to patients. Each position at uniQure is directly or indirectly responsible to improving the lives of patients. This responsibility is part of our day-to-day working life by living up to high quality standards and by recognizing the sense of urgency in areas of high unmet medical need. The...

Job Description Job: Validation Lead (CSV, Clinical Systems) Location:NJ/PA(Hybrid) Mandatory Skills: CSV, Computer System Validation, Clinical Systems, periodic review and audit experience Roles and Responsibilities: We are looking for a pure validation resource 8 + years Experience in Validating GxP applications Experience in FDA and/or Global regulated...

Job Description Job: Validation Lead (CSV, Clinical Systems) Location:NJ/PA(Hybrid) Mandatory Skills: CSV, Computer System Validation, Clinical Systems, periodic review and audit experience Roles and Responsibilities: We are looking for a pure validation resource 8 + years Experience in Validating GxP applications Experience in FDA and/or Global regulated...

About the job SAP Validation Lead Job Requirements: This position is responsible for leading and performing activities in support of creating and maintaining GxP (GMP, GCP, GLP) quality and compliance environment for SAP S/4 HANA. This position is also responsible for monitoring Computer System validation (CSV) as well as compliance with GxP regulations and...

In the role of Core Firmware Validation Engineering Manager, you will be helping to define and execute the strategic verification and validation vision of the Core Firmware engineering teams at Zoox. You will direct the activities of a team of Core Firmware component verification and validation engineers while coordinating and collaborating with other...

About the job SAP Validation Lead Job Requirements: This position is responsible for leading and performing activities in support of creating and maintaining GxP (GMP, GCP, GLP) quality and compliance environment for SAP S/4 HANA. This position is also responsible for monitoring Computer System validation (CSV) as well as compliance with GxP regulations...

JOB Description: Roles and Responsibilities 2-4 years Experience in Validating SAP systems in Manufacturing Experienced in CSV activities in Manufacturing related applications like SAP Systems, Product Serialization systems, MES systems Perform review for GxP systems to ensure compliance with regulatory requirements. Working knowledge on end-to-end...

Foster City, CA / Software Embedded Software & Systems Integration / Full-time/ Hybrid. In the role of Core Firmware Validation Engineering Manager, you will be helping to define and execute the strategic verification and validation vision of the C Manager, Validation, Firmware, Validation Engineer, Firmware Engineer, Technology, Management

Responsibilities : Responsible for preparing and executing test documentation for GMP computerized systems as well as providing support in the troubleshooting of issues during test execution. You should have excellent understanding of CFR Part , ICH standards, EMA and FDA (GxP) regulations, and GAMP methodologies. Coordinate with...

Summary DPS Group is seeking a CSV (MES) Engineer to support a client in Devens, MA. The candidate must have MES 3.0 and experience in a pharma/biotech GMP Environment. Responsibilities Provide technical support for ensuring that current versions of the Computer System are qualified through verification and maintained in a qualified state Accurately record...

The Component and System Hardware Validation team at Zoox is responsible for ensuring our components and sub-systems on the Zoox robotaxi meet all functional and reliability targets needed to facilitate our autonomous mobility service. Our team has an action-biased culture marked by integrity, humility, competence, and passion for the Zoox mission and the...

The Component and System Hardware Validation team at Zoox is responsible for ensuring our components and sub-systems on the Zoox robotaxi meet all functional and reliability targets needed to facilitate our autonomous mobility service. Our team has an action-biased culture marked by integrity, humility, competence, and passion for the Zoox mission and the...