CQV Engineer; Louisville

Louisville, United States

Pioneer GMP Consulting is a specialized life sciences consultancy focused on delivering high-impact GMP compliance, validation, and quality system solutions to biopharmaceutical clients. We support startups, CDMOs, and global manufacturers across the product lifecycle, from clinical-stage development to commercial readiness.

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

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.

• 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

• 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

• 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…