Validation Engineer, Veeva RIMS - Foster City, United States - I.T. Solutions, Inc.

I.T. Solutions, Inc. Foster City, United States

3 weeks ago

Description

Validation Engineer, Veeva RIMS

Location: Foster City, CA

Length: 12+ Months to start with + likely extensions (long term role)

Responsibilities:

Computer System Validation processes experience
Maintain expertise in current and emerging GMP requirements and quality trends (e.g., 210, 211, 820, and 21 CFR Part 11).
Work independently on and successfully solve problems and complete/qualify a system within given constraint of scope, time and schedule.
Experience in system qualification and regulatory compliance and internal requirements employing regulatory guidance and industry standards.

Qualifications:

Bachelor's degree in scientific or engineering discipline along with 5 plus years of experience in the field of computer systems validation.
Experience in system qualification and regulatory compliance and internal requirements employing regulatory guidance and industry standards.
Computer System Validation Engineers must have excellent verbal communication and technical writing skills.
Experience with all pertinent industry best practices including development and execution of all applicable system life cycle deliverables (e.g., URS, SRS, FRS, DDS, RTM, Unit, Integration, User Acceptance testing, Delta V, FAT, SAT, Validation Planning, IQ, OQ, PQ, Final Validation Summary Report).
Working knowledge of the development of protocols for the Validation of complex computer systems (e.g., multiple GAMP classes of systems); Protocol development will include ability to develop Installation, Operational and Performance qualification documents.
RIM experience a nice to have
Ability to plan and manage own work

Deliverables:

Ensures validation is being performed per established procedure, review validation documentation, and coordinating between direct groups for the same.,
Communicate to different stakeholders and management on the progress of validation efforts
Work with project team for identifying the activities of project, dependencies, and figure out future enhancements.
Execute protocols or peer review protocols depending on the level of access required for execution.
Support the routing and accurate documentation of all Change Management, Deviation and Corrective Actions Preventative Actions (CAPAs).
Assist in Performing Risk and Impact assessment for validation activities and change requests.
Support Data Integrity Assurance Program for all documentation managed by their team.

Validation Engineer, Veeva RIMS

3 weeks ago

IT Solutions LLC Foster City, United States

Validation Engineer, Veeva RIMS · Location: Foster City, CA · Length: 12+ Months to start with + likely extensions (long term role) · Responsibilities: · Computer System Validation processes experience · Maintain expertise in current and emerging GMP requirements and quality tre ...
Validation Engineer

4 weeks ago

I.T. Solutions, Inc. Foster City, United States

Role: Validation Engineer, RIM · Location: Remote · A High School Diploma with 6+ years of relative experience OR an Associates Degree with 5+ years of relative experience OR A Bachelor's Degree with 4+ years of relevant experience or a Master's Degree (M.S./MBA)with 2+ years of ...
Business System Analyst

2 weeks ago

Katalyst Healthcares and Life Sciences Foster City, United States

Responsibilities: Business Analyst with IT GxP process and Business Process implementation experience. This person will need to be able to work in a very fast-paced and dynamic environment. · Experience working in the Biotech/Pharma Industry. · Develop and optimize test scripts ...
Director, Global Regulatory Affairs Labeling

1 week ago

Mirum Pharmaceuticals Foster City, United States

POSTION SUMMARY · The Director, Regulatory Affairs Global Labeling will play a key role in providing regulatory expertise and guidance to internal stakeholders for successful development and implementation of global regulatory labeling strategy and documentation for marketed pro ...
Sr. Regulatory Document Formatting Specialist

2 days ago

Vaxcyte, Inc. San Carlos, United States Full time

Join our Mission to Protect Humankind · Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to er ...
Senior Manager, Regulatory Operations

2 weeks ago

Meet Recruitment Menlo Park, United States

Manager or Senior Manager, Regulatory Operations · *Hybrid Workstyle - Menlo Park, CA* · Meet has partnered with an exceptional Bay Area pharma focused in treatments for metabolic, psychiatric, and oncologic disorders. Our client has an approved product and a dynamic late-stage p ...
Senior Manager, Regulatory Operations

3 weeks ago

Meet Menlo Park, United States

Senior Manager, Regulatory Operations · This role, reporting to the Director of Regulatory Operations, entails overseeing the regulatory archives within the Veeva Vault system and internal shared drive. The Manager/Senior Manager will collaborate with a multifaceted team, provid ...
Senior Manager, Regulatory Operations

1 week ago

Meet Recruitment Menlo Park, United States

Senior Manager, Regulatory Operations · This role, reporting to the Director of Regulatory Operations, entails overseeing the regulatory archives within the Veeva Vault system and internal shared drive. The Manager/Senior Manager will collaborate with a multifaceted team, providi ...
Veeva Regulatory Information Management Database

2 weeks ago

Dotsher Inc South San Francisco, United States

Role - Veeva Regulatory Information Management Database (RIM) · 6+ months contract · Location - South San Francisco, CA · Start: ASAP · Responsibilities include: · Create standard operating process for Veeva naming conventions (Metadata) for regulatory documents. · Create, ...
Manager/Senior Manager, Regulatory Operations

2 weeks ago

Corcept Therapeutics Menlo Park, United States

Corcept is leading the way in the research and development of cortisol modulators, molecules that regulate cortisol activity at the glucocorticoid receptor (GR). To date, we have discovered more than 1,000 selective proprietary cortisol modulators. · In 2012, we received FDA app ...
Veeva Regulatory Information Management Database

2 weeks ago

Dotsher Inc South San Francisco, United States

Role - Veeva Regulatory Information Management Database (RIM) · 6+ months contract · Location - South San Francisco, CA · Start: ASAP · Responsibilities include: · Create standard operating process for Veeva naming conventions (Metadata) for regulatory documents. · Create, ...
Manager/Senior Manager, Regulatory Operations

3 weeks ago

Corcept Therapeutics Menlo Park, CA, United States

Corcept is leading the way in the research and development of cortisol modulators, molecules that regulate cortisol activity at the glucocorticoid receptor (GR). To date, we have discovered more than 1,000 selective proprietary cortisol modulators.In 2012, we received FDA approva ...
Senior Manager Regulatory Affairs

3 weeks ago

Proclinical Staffing Palo Alto, United States Permanent

Senior Manager Regulatory Affairs - Remote - Permanent · Proclinical is actively seeking a Senior Manager for Regulatory Affairs. This is a remote permanent position. This role is integral to the ongoing development, registration, and life-cycle management of our product candida ...
Senior Manager Regulatory Affairs

2 weeks ago

Proclinical Staffing Palo Alto, United States

Senior Manager Regulatory Affairs - Remote - Permanent · Proclinical is actively seeking a Senior Manager for Regulatory Affairs. This is a remote permanent position. This role is integral to the ongoing development, registration, and life-cycle management of our product candida ...
RIM Data Quality Associate Manager

5 days ago

BeiGene Emeryville, United States

**General Description:** · The Associate Manager (AM), Regulatory Information Management (RIM) will serve as the global knowledge-center for the Regulatory Information Management System (RIM) Data Quality & Reporting. The AM will partner with key RIM data owners, RegTech, & RIM ...
Senior Manager, Computerized Systems Quality Assurance

2 weeks ago

Kyverna Therapeutics Emeryville, United States

Kyverna is recruiting a highly motivated Senior Manager of Computer Software Assurance (Computer System Validation) in its Quality organization to help advance its mission to free patients from the siege of autoimmune disease. The ideal candidate will build and lead a Software Qu ...
Senior Manager, Computerized Systems Quality Assurance

3 weeks ago

Kyverna Therapeutics Emeryville, United States

Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases. The Kyverna therapeutic platform leverages advanced T cell engineering to suppress and eliminate autoreactive ...
Director, Clinical R&D Applications

3 weeks ago

4D Molecular Therapeutics Inc. Emeryville, United States

GENERAL SUMMARY: · This role is responsible for leading & managing the technology & data strategy & execution for the Clinical R&D functions. This includes developing & implementing technical & compliant solutions that support the clinical research & development processes, from s ...
Director, Clinical R&D Applications

3 weeks ago

BioSpace Emeryville, United States

Job Details · Attention recruitment agencies: All agency inquiries are vetted through 4DMT's internal Talent Acquisition team. No unsolicited resumes will be accepted. Agencies must be expressly engaged by the 4DMT Talent Acquisition team on any requisition. Agencies reaching ou ...
Sr. Regulatory Affairs Specialist

4 days ago

Intuitive Sunnyvale, United States

Company Description · At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints. · As a pioneer and market leader ...