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CQV Engineer – Periodic Review and Requalification

• Location: Louisville, CO
• Work Type: 100% Onsite
• Anticipated Start: Q1 2027
• Initial Duration: Approximately 3–6 Months
• Schedule: Full-Time
• Employment Type: W2 Employee of Pioneer GMP Consulting
• Opportunity Status: Anticipated engagement pending final client approval and 2027 budget authorization
• Candidate Deck: CQV Engineer - Periodic Reviews & Requalification

About the Opportunity

Pioneer GMP Consulting is seeking a mid- to senior-level CQV Engineer for an anticipated staff-augmentation engagement at a GMP-regulated manufacturing site in Louisville, Colorado.

The consultant will provide hands-on support for an established periodic-review and requalification program. This role requires an experienced CQV professional who can quickly integrate with the client team, independently manage assigned systems and activities, execute qualification work in the field, and complete accurate, inspection-ready documentation.

The initial engagement is expected to last approximately three to six months, with the potential for extension based on project needs and consultant performance.

This opportunity is being planned for Q1 2027 and remains subject to final client approval, budget authorization, and project scheduling.

What You’ll Do

• Execute periodic reviews and requalification activities for assigned GMP equipment, utilities, facilities, and systems
• Review existing qualification packages and system lifecycle documentation
• Evaluate change controls, deviations, maintenance history, calibration status, previous qualification results, and other information affecting the validated state
• Determine and document requalification requirements in accordance with approved procedures and risk-based principles
• Develop, revise, review, and execute requalification protocols
• Perform hands-on field verification and testing
• Verify system configuration, instrumentation, operating parameters, alarms, interlocks, and system functionality as applicable
• Document and resolve protocol discrepancies, deviations, punch-list items, and documentation gaps
• Prepare periodic-review assessments, qualification reports, and supporting documentation
• Support change controls, corrective actions, and follow-up activities associated with qualification findings
• Coordinate activities with Validation, Engineering, Quality, Operations, Maintenance, Metrology, Automation, and system owners
• Manage assigned deliverables independently and communicate progress, risks, constraints, and readiness concerns
• Maintain complete, accurate, traceable, and inspection-ready documentation
• Identify practical opportunities to improve execution and support the client’s requalification program
• Represent Pioneer with professionalism, technical credibility, sound judgment, and accountability

Required Qualifications

• At least five years of CQV, commissioning, qualification, or validation experience in GMP pharmaceutical, biotechnology, or life sciences manufacturing
• Direct experience performing periodic reviews and equipment or system requalification
• Hands-on experience developing and executing IQ, OQ, PQ, or requalification protocols
• Experience reviewing qualification history, change controls, deviations, maintenance records, and calibration information
• Experience assessing whether equipment and systems remain in a qualified and controlled state
• Experience documenting and resolving protocol discrepancies and deviations
• Strong understanding of validation-lifecycle principles and maintaining systems in a validated state
• Strong knowledge of cGMP requirements and good documentation practices
• Strong technical-writing and qualification-report experience
• Ability to manage assigned systems and deliverables with limited supervision
• Ability to collaborate effectively with technical, operational, and Quality stakeholders
• Ability to work onsite in Louisville, Colorado, five days per week throughout the engagement
• Residence within commuting distance of Louisville or the ability to independently establish a local presence before the engagement begins
• Bachelor’s degree in engineering, life sciences, or a related technical discipline, or equivalent relevant industry experience

What Will Set You Apart

• Experience executing sitewide or multi-system periodic-review and requalification programs
• Experience assessing legacy equipment or systems with incomplete or inconsistent qualification documentation
• Experience supporting qualification remediation or inspection-readiness initiatives
• Experience applying risk-based periodic-review and requalification methodologies
• Experience managing a high volume of concurrent systems and qualification deliverables
• Experience with electronic validation, calibration, maintenance, or asset-management systems
• Prior CQV consulting or staff-augmentation experience
• Experience entering an established program and becoming productive with minimal ramp-up time
• Local availability within commuting distance of Louisville, Colorado
• Flexibility to travel or support future Pioneer assignments in different locations

Consulting at Pioneer

Consulting is different from working in a traditional, fixed position. Pioneer consultants work as embedded members of client teams, where project priorities, schedules, responsibilities, and timelines may evolve.

Success requires flexibility, responsiveness, hands-on execution, strong client service, and the ability to build trusted relationships while maintaining sound technical and quality judgment. Consultants must remain connected to Pioneer, communicate risks early, honor their commitments, and adapt as client needs change.

The work arrangement for this initial engagement is a firm requirement. Future Pioneer assignments may involve different clients, locations, schedules, responsibilities, or travel expectations.

About Pioneer GMP Consulting

Pioneer GMP Consulting provides quality, compliance, validation, engineering, regulatory, technology, and operational support to pharmaceutical, biotechnology, and life sciences organizations.

Our consultants remain connected to and supported by Pioneer’s leadership and network of industry experts while working alongside client and project teams.

Compensation and Benefits

Compensation is determined based on experience, technical expertise, engagement requirements, and other job-related factors.

Eligible regular, full-time employees may receive:

• Medical insurance, with Pioneer currently contributing 50% of employee premiums
• Dental insurance
• Vision insurance
• $100,000 basic life insurance
• 401(k) retirement plan
• 12 paid holidays
• Flexible PTO

Benefits are subject to eligibility requirements and the terms of the applicable plan documents. Benefit offerings may change over time.

Equal Opportunity Employer

Pioneer GMP Consulting is an Equal Opportunity Employer. We do not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other protected category under applicable law.