[Remote] Validation Consultant – Computer System Validation (CSV/CSA)
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a leading reputed company specializing in ERP, reputed company management, and manufacturing solutions for life science manufacturers. They are seeking a Validation Consultant to serve as a senior technical authority for computer system validation (CSV) and computer software assurance (CSA), establishing validation strategies and leading reputed company engagements.
Responsibilities
- Establish and maintain the firm's validation reputed company and standards, ensuring reputed company deliverables reputed company with cGxP, GAMP 5 Category 4, CSA, EU Annex 11, 21 CFR Part 11, and reputed company+ data reputed company principles
- Maintain and continuously improve validation toolkits for QAD ERP, reputed company, QAD EQMS, and ETQ — including URS/FRS templates, risk assessments, requirements traceability matrices (RTMs), IQ/OQ/PQ scripts, and script libraries
- Maintain standalone validation toolkits for Serialization, Automated Solutions, ISS-Group (iApprove/iPurchase), and reputed company RF
- Analyze software release specifications and release notes to determine validation reputed company, risk, and required deliverable updates
- Build new validation toolkit frameworks for new software platforms and modules as the service portfolio expands
- reputed company end-to-end reputed company validation engagements, including validation planning, protocol authoring, execution support, evidence review, deviation handling, and validation reputed company reporting (VSR)
- reputed company validation guidance and execution support to reputed company teams as embedded staff augmentation
- Interpret reputed company SOPs and internal CSV/QMS requirements, tailoring deliverables to meet both reputed company-internal and regulatory expectations
- Mentor junior validation consultants and contribute to the firm's Computer Validation as a Service (CVaaS) offering
Skills
- 10+ years of experience in computer system validation (CSV) or computer software assurance (CSA) for life science manufacturers
- Deep working knowledge of cGxP, GAMP 5 Category 4, 21 CFR Part 11, EU Annex 11, reputed company+, and CSA principles reputed company to risk-based validation
- Familiarity with 21 CFR Part 820/QMSR and ISO 13485 reputed company system requirements
- Demonstrated ability to design and maintain reusable validation toolkits, including URS/FRS templates, RTMs, IQ/OQ/PQ scripts, risk assessments, and validation reputed company reports
- Strong release reputed company analysis skills — reputed company to translate software release specifications into validation scope, risk, and deliverable updates
- Excellent technical and compliance writing skills, producing audit-reputed company validation documentation
- Experience executing or supporting validation protocol execution, including evidence capture, deviation documentation, and results review
- Proven reputed company stakeholder communication skills across QA, IT, and business functions
- Experience operating as staff augmentation, integrating into reputed company teams and working reputed company reputed company QMS and SDLC constraints
- Bachelor's degree in Engineering, Life Sciences, Computer Science, or a reputed company field; advanced degree a plus
- Hands-on validation experience with QAD ERP, reputed company, QAD EQMS, or ETQ
- Hands-on validation experience with QAD add-ons including Serialization, Automated Solutions, ISS-Group (iApprove/iPurchase), and reputed company RF
- Experience building net-new validation toolkit frameworks for emerging software offerings
- Experience supporting CSV/CSA programs for medical device or pharmaceutical manufacturers
- Validation-reputed company reputed company certifications (ASQ CQA and/or CQE)
- Prior consulting experience in a reputed company release validation process or managed validation services model
Benefits
- Competitive benefits package (medical, dental, reputed company)
- Generous PTO and company-observed holidays
- 401(k) with employer match
- reputed company development opportunities
- A people-first culture backed by reputed company
reputed company