Advanced Quality​/Validation Engineer

Overview

As an Advanced CQV Consultant you are responsible for planning, execution, and delivery of commissioning, qualification, and validation (CQV) activities within pharmaceutical, biotechnology, and life science projects. This role independently executes complex CQV deliverables while serving as the Project Quality Manager (PQM) on assigned projects, ensuring quality, compliance, and validation strategies are aligned with customer requirements, industry standards, and regulatory expectations.

The consultant works as part of multidisciplinary project teams and serves as a subject matter expert in CQV, quality risk management, GMP compliance, and validation lifecycle activities from project initiation through handover.

• Lead commissioning, qualification, and validation (CQV) activities for facilities, utilities, equipment, and computerized systems.
• Develop and review CQV lifecycle documentation, including validation plans, risk assessments, IQ/OQ/PQ/PfV protocols, traceability matrices, and summary reports.
• Execute qualification activities, troubleshoot technical and compliance challenges, and ensure compliance with GMP regulations, industry standards, and company procedures.
• Collaborate with engineering, automation, quality, and manufacturing teams while supporting FAT, SAT, startup, and commissioning activities.
• Identify and elevate project risks, scope changes, and compliance concerns.

• Serve as Project Quality Manager (PQM) on small to mid‑sized projects, defining and managing validation and quality deliverables.
• Align project quality strategies with client expectations and regulatory requirements, while monitoring budgets, resources, risks, and quality outcomes.
• Support Quality Assurance Plans (QAPs), facilitate GMP, GEP, ASTM E2500, and design reviews, and provide quality oversight across project disciplines.
• Act as a trusted advisor to both project teams and clients on quality and compliance matters.

• Build strong client relationships and provide technical guidance on CQV and validation strategies.
• Support proposals, project planning, cost estimates, and business development activities.
• Present project progress, risks, and mitigation plans to stakeholders and leadership.
• Mentor junior consultants, promote validation and quality best practices, and contribute to knowledge‑sharing and continuous improvement initiatives.

Bachelor's or Master's degree in Engineering, Life Sciences, Biotechnology, Pharmaceutical Sciences, or a related field.

• 8+ years of CQV, Quality, Validation, or GMP consulting experience within the pharmaceutical, biotechnology, or life sciences industry.
• Experience leading qualification and validation programs for GMP‑regulated facilities.
• Experience as a Quality Lead, Validation Lead, or Project Quality Manager on complex projects.
• Strong knowledge of GMP regulations (FDA, EMA, ICH), GAMP 5, ASTM E2500, ISPE Baseline Guides, Quality Risk Management, Data Integrity, and Validation Lifecycle Management.

• Experience supporting large capital projects, clean utilities, process equipment, facilities, and automation systems.
• PMP, ASQ, ISPE, or similar professional certification.
• Client‑facing consulting experience.

• Competitive salary with annual adjustment increases
• 160 hours of PTO (prorated from hire date) + 14 paid holidays
• Health, dental, and vision insurance from day one
• 8% guaranteed 401(k) company contribution
• 14 weeks paid parental leave
• Company‑paid life and disability insurance
• Employee referral bonuses