Computer System Validation (CSV) Consultants Piscataway, NJ, US
- Posted 14 days ago
- Updated 5 hours ago Contract W2 Contract Independent On-site Fitment Dice Job Match Score™ 🔢 Crunching numbers.
.. Job Details Skills Change Control Manufacturing GxP risk analysis System Testing Calibration functional design Biotechnology SAP (Applications) Enterprise Software Applications Validation Protocols Laboratory Information Management Systems Carrying out Assessments Computerized Maintenance Management Systems Conduct of Business Sourcebook Content Creation Design Specifications FDA Regulations Iq/oq/pq Manufacturing Laboratory Traceability Matrix User Requirements Documents Auditing Skills Biology Corrective and Preventive Action Health Sciences Laboratory Techniques SAP Quality Management System Lifecycle Change Control Manufacturing GxP risk analysis System Testing Calibration functional design Biotechnology SAP (Applications) Enterprise Software Applications Validation Protocols Laboratory Information Management Systems Carrying out Assessments Computerized Maintenance Management Systems Conduct of Business Sourcebook Content Creation Design Specifications FDA Regulations Iq/oq/pq Manufacturing Laboratory Traceability Matrix User Requirements Documents Auditing Skills Biology Corrective and Preventive Action Health Sciences Laboratory Techniques SAP Quality Management System Lifecycle Summary Job Title
- Computer System Validation (CSV) Consultants Location
- Piscataway, NJ/Chicago, IL (Onsite) Duration
- Contract to hire Job Description Responsibilities Plan, author, execute, and maintain CSV documentation including Validation Plans (VP), User Requirements Specifications (URS), Functional Specifications (FS), Design Specifications (DS), IQ/OQ/PQ protocols, Traceability Matrices, and Validation Summary Reports .
Perform CSV activities for laboratory instruments, engineering/manufacturing equipment, and enterprise applications . Validate systems including LIMS, SAP, CMMS/calibration platforms , and other GxP-regulated applications. Partner with system owners, Quality, IT, Laboratory, and Manufacturing teams to maintain systems in a validated state through change control and periodic reviews . Conduct risk assessments and data-integrity assessments aligned with ALCOA+ principles. Support audits, inspections, CAPAs, deviations, and remediation activities related to computerized systems. Apply GAMP 5 and risk-based validation principles throughout the system lifecycle. Support validation activities involving Caliber
LIMS, SAP
QM/MM/PP, BMRAM or comparable CMMS/calibration systems where applicable. Required Qualifications 5+ years of Computer System Validation experience within a GxP-regulated environment. Strong, demonstrable CSV experience specifically within Biotechnology/Biotech environments
REQUIRED.
Hands-on experience authoring and executing
IQ/OQ/PQ
protocols . Strong working knowledge of 21 CFR Part 11, EU Annex 11, GxP, GAMP 5, and risk-based validation . Experience validating at least two of the following: Laboratory instruments Manufacturing/engineering equipment
LIMS SAP
CMMS/calibration systems Experience working cross-functionally with Quality, IT, Laboratory, Manufacturing, and technical SMEs . Bachelor's degree in Life Sciences, Engineering, IT, or equivalent relevant life-sciences laboratory experience. Ability and willingness to work onsite 5 days per week . Candidates must be interested and eligible for a contract-to-hire opportunity . Employers have access to artificial intelligence language tools ("AI") that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
Dice Id:
10170376
Position Id:
2026-1230 Posted 14 days ago
