Senior Validation Consultant, CSV/CSA - Life Sciences

Pine Services; United States; On-site; USD 130,000 - 180,000; Full time

Benefits offered by this job

Remote work (US)

Travel ~10%

Medical benefits

401(k) with company match

Job summary

Pine Services, a leading life sciences consulting firm, seeks a Validation Consultant to lead CSV/CSA programs across QAD, NetSuite, ETQ, and related platforms. You’ll establish validation strategy, develop reusable toolkits, and deliver inspection-ready packages compliant with cGxP, GAMP 5, and 21 CFR Part 11. Remote US with ~10% travel.

You will mentor junior consultants and work within CVaaS offerings, aligning with client QMS constraints and regulatory expectations.

Qualifications

• 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, ALCOA+, and CSA principles applied to risk-based validation.
• Familiarity with 21 CFR Part 820/QMSR and ISO 13485 quality system requirements.
• Demonstrated ability to design and maintain reusable validation toolkits, including URS/FRS templates, RTMs, IQ/OQ/PQ scripts, risk assessments, and validation summary reports.
• Strong release impact analysis skills — able to translate software release specifications into validation scope, risk, and deliverable updates.
• Excellent technical and compliance writing skills, producing audit-ready validation documentation.
• Experience executing or supporting validation protocol execution, including evidence capture, deviation documentation, and results review.
• Proven client stakeholder communication skills across QA, IT, and business functions.
• Experience operating as staff augmentation, integrating into client teams and working within client QMS and SDLC constraints.
• Bachelor's degree in Engineering, Life Sciences, Computer Science, or a related field; advanced degree a plus.

Responsibilities

• Establish and maintain the firm's validation strategy and standards, ensuring all deliverables align with cGxP, GAMP 5 Category 4, CSA, EU Annex 11, 21 CFR Part 11, and ALCOA+ data integrity principles.
• Maintain and continuously improve validation toolkits for QAD ERP, NetSuite, QAD EQMS, and ETQ — including URS/FRS templates, risk assessments, RTMs, IQ/OQ/PQ scripts, and script libraries.
• Maintain standalone validation toolkits for Serialization, Automated Solutions, ISS-Group (iApprove/iPurchase), and Eagle RF.
• Analyze software release specifications and release notes to determine validation impact, risk, and required deliverable updates.
• Build new validation toolkit frameworks for new software platforms and modules as the service portfolio expands.
• Lead end-to-end client validation engagements, including validation planning, protocol authoring, execution support, evidence review, deviation handling, and validation summary reporting (VSR).
• Provide validation guidance and execution support to client teams as embedded staff augmentation.
• Interpret client SOPs and internal CSV/QMS requirements, tailoring deliverables to meet both client-internal and regulatory expectations.
• Mentor junior validation consultants and contribute to the firm's Computer Validation as a Service (CVaaS) offering.

Skills

CSV/CSA experience

Regulatory compliance

Client stakeholder communication

Staff augmentation experience

Risk-based validation

Education

Bachelor's degree in Engineering, Life Sciences, Computer Science or related field

Tools

QAD ERP

NetSuite

QAD EQMS

ETQ

Job description

Pine Services, a leading life sciences consulting firm, seeks a Validation Consultant to lead CSV/CSA programs across QAD, NetSuite, ETQ, and related platforms. You’ll establish validation strategy, develop reusable toolkits, and deliver inspection-ready packages compliant with cGxP, GAMP 5, and 21 CFR Part 11. Remote US with ~10% travel.

You will mentor junior consultants and work within CVaaS offerings, aligning with client QMS constraints and regulatory expectations.