Validation Engineer III C

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CSI (Consultant Specialists Inc.)
SQA, Change Control, Clinical Data Management, Clinical Trials, GLP, GCP, Validation, Sharepoint, LIMS
Contract W2, 6 Months
Depends on Experience
Work from home not available Travel not required

Job Description






Validation Engineer III


Required Skills:
ARCHITECTURE
CHANGE CONTROL
CLINICAL DATA MANAGEMENT
CLINICAL TRIALS
DATA MANAGEMENT


Duties:


Client is seeking a strong GCP/GLP Validation & Quality Engineer to support validation activities for GCP/GLP computer systems in Product Development.

- General requirements : LIMS, Sharepoint etc.
- Make sure that the applicable regulations, guidelines and internal procedures related to validation of GCP/GLP computer systems are followed and applied during all stages of the defined software development life cycle (SDLC)
- Provide guidance on testing, validation and documentation to project managers, IT project teams, and database administrators.
- Review and approve SDLC documentation.
- Collaborate with other Systems Specialists, and assist in resolving technical and project-related issues.
- Bachelor s degree in Computer Science or a related discipline, and at least six years of commercial validation experience in a GxP environment in the biotech or pharmaceutical industry.
- Formal training and proficiency in systems development methodologies and computer systems validation in regulated industries.
- Expertise in interpretation of the applicable regulations that impact computer systems (e.g., 21 CFR Parts 11, 50, 58, 312) used in GxP environment and related FDA guidelines, regulations, as well as ICH GCP guidelines.
- Application of industry guidance and best practices regarding the validation and documentation of computer systems (e.g., GAMP).
- Must be able to manage multiple tasks, be able to work independently, and have strong oral and written communication skills. Customer focus and being a team player are a must.
Additional Description:
- The candidate must have a sound understanding of the principles of Computerized Information System (CIS) validation in regulated industries (GAMP, Part 11, FDA guidelines and regulations).
- Knowledge and experience with system/database design and architecture, change control, as well as System Development Life Cycle (SDLC) and Quality Assurance (QA) methodologies is required.
- A good understanding of GLP and GCP regulations and experience in the validation of CIS used in clinical and non-clinical trials (e.g., LIMS, Clinical Data Management) is desired.
- The successful candidate will be responsible for maintaining change control, reviewing validation strategies and providing guidance for testing protocols (IQ/OP/PQ) used in the support of CIS used in clinical and non-clinical trials.
- The candidate will also generate validation deliverables as needed for GLP and GCP projects.
Skills:
- Minimum 5 years/+ of experience in SQA. Resource needed to review/approve validation deliverables for multiple ongoing projects running in parallel.
Education:
- BS in Computer Science preferred.
Additional Skills:
DATABASE
DATABASE DESIGN
DOCUMENTATION
ENGINEER
FDA
GCP
GLP
GXP
ICH
LIFE CYCLE
LIMS
QA
QUALITY ASSURANCE
SDLC
SHAREPOINT
SOFTWARE DEVELOPMENT
SOFTWARE DEVELOPMENT LIFE CYCLE
SQA
SYSTEM DEVELOPMENT
SYSTEMS DEVELOPMENT
TEAM PLAYER
TRAINING
VALIDATION ENGINEER
DATABASES
MICROSOFT SHAREPOINT
PRODUCT DEVELOPMENT
QUALITY ENGINEER
STRUCTURED SOFTWARE



Posted By

Jackie Felipe



Company Information

Consultant Specialists, Inc. is a small, specialized firm, built and operated by staffing industry veterans with many years experience. We are a full-service technical staffing firm focused on providing technical consultants on a contract basis to companies San Francisco, San Jose and across Northern California. As a small firm, CSI is extremely flexible and fast while remaining cost competitive. Recruiting the best of the best gets more done in less time. We rely on our comprehensive internal database, rather than soliciting resumes to fill positions. This gives our clients the best IT resources at competitive prices and provides our consultants with access to the most desirable positions.
Dice Id : 10106409
Position Id : 9089397ValEngr
Originally Posted : 5 months ago

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