CSV Quality Engineer Lead

Description

Salary Range
$90 – $120 / hour

Work Policy
Fully Remote

Experience Level
Senior (7+ years required)

Job Type
Part-Time (approximately 20 hours per week)

A growing technology company serving pharmaceutical and other regulated manufacturing environments is looking for an experienced CSV Quality Engineer Lead. This is a Quality leadership role, not a hands-on validation-execution job — Engineering, Product, and other designated teams will write requirements, run tests, and produce technical evidence, while this role provides independent Quality governance: setting expectations, reviewing and approving validation strategies, assessing risk, spotting compliance gaps, and confirming systems stay in a validated, controlled state.

About the Role

Beyond CSV oversight, the successful candidate will help build and mature the company’s broader quality infrastructure — developing SOPs, implementing document and change controls, overseeing deviations and CAPAs, setting up training and supplier-quality processes, running quality reviews, and getting the organization ready for customer audits. The role requires maintaining genuine Quality independence while still partnering constructively with Engineering, Product, Operations, and leadership.

What You’ll Do

• Lead the development and continuous improvement of the company’s quality management system, including running a QMS gap assessment and building a risk-based rollout roadmap.
• Author, review, approve, and maintain quality policies, SOPs, work instructions, templates, and controlled records.
• Build out effective processes for document and record control, change control, deviations and nonconformances, CAPAs, risk management, training records, supplier qualification, internal audits, management review, periodic system review, and quality review of product releases.
• Track adherence to approved procedures, follow up on gaps, and set up meaningful quality metrics to report risks, trends, and open items to leadership.
• Keep the quality system practical and scalable for a growing tech company rather than over-engineered.
• Set the company’s policies and standards for computerized system validation, and provide independent Quality oversight of validation work done by Engineering, Product, suppliers, or customers.
• Review and approve validation plans, intended-use statements, requirements, risk assessments, traceability matrices, test strategies, protocols, deviations, and validation summary reports.
• Confirm that validation scope and evidence genuinely match a system’s intended use, complexity, and risk level, and that requirements are clear, testable, and traceable.
• Decide when engineering or supplier testing can be leveraged as validation evidence, and when independent Quality review is needed instead.
• Review validation deviations to make sure they’re properly investigated, documented, resolved, and approved.
• Confirm controls for audit trails, e-signatures, user access, security, backup/recovery, and data retention meet applicable standards.
• Keep systems in a validated state through controlled changes, periodic reviews, and documented risk assessments, and provide Quality sign-off for validation completion and regulated product releases.
• Escalate material quality, compliance, or data-integrity risks to leadership.
• Get the organization ready for customer audits, supplier assessments, and regulatory inspections, keeping quality records organized and inspection-ready.
• Support customer questionnaires, quality agreements, validation requests, and due-diligence reviews, and represent Quality during customer audits.
• Coordinate responses to audit findings and track corrective actions through to closure.
• Review suppliers whose work could affect product quality, data integrity, regulatory compliance, or the validated state of a system.

What You’ll Need

• At least 7 years of Quality experience in pharmaceutical, biotechnology, life-sciences technology, or another highly regulated industry.
• A track record of building or significantly improving a quality management system.
• Strong experience providing independent Quality oversight of computerized system validation, with a clear understanding of the line between doing validation work and reviewing/approving it.
• Experience reviewing and approving validation plans, requirements, risk assessments, traceability matrices, test evidence, deviations, and summary reports.
• Solid working knowledge of FDA 21 CFR Part 11, EU GMP Annex 11, PIC/S GMP expectations, GAMP 5, and ALCOA+ data-integrity principles.
• Experience with document control, change control, CAPA, deviations, training, supplier quality, internal audits, and management review.
• Ability to judge whether software-testing evidence is adequate and traceable without acting as the routine tester yourself.
• Experience supporting customer audits or regulatory inspections.
• Strong technical writing, judgment, organizational, and communication skills.
• Ability to work independently while building effective partnerships across technical and business teams.
• Reliable availability for roughly 20 hours a week.

Nice to Have

• Experience building a fit-for-purpose QMS for a software, SaaS, IoT, laboratory technology, or life-sciences technology company.
• Experience overseeing validation of systems that combine software, hardware, edge devices, scientific instruments, and external integrations.
• Familiarity with LIMS, MES, ELN, QMS, laboratory automation, or scientific instrument connectivity.
• Experience with quality expectations across the US, Europe, and Asia-Pacific, including Japan’s PMDA and other PIC/S-aligned authorities.
• Experience reviewing cloud infrastructure and third-party technology providers from a Quality and validation lens.
• The judgment to add the right amount of regulatory rigor without creating unnecessary bureaucracy.