CQV Engineer (Louisville, CO)

Pioneer GMP Consulting•Louisville, CO

1d•Onsite

About The Position

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.

Requirements

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

Nice To Haves

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

Responsibilities

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