CQV Engineer (Bloomington, IN)

CQV Engineer – Aseptic Filling Line and Isolator

When an engagement concludes, Pioneer will work to identify another client opportunity that aligns with the consultant’s experience and capabilities. The timing and availability of future assignments depend on client demand and cannot be guaranteed.

About the Opportunity

The filling line and associated manufacturing space are currently in long-term hold and will be returned to GMP operation. The scope includes modifications required for the new product and the commissioning and qualification activities necessary to return the existing equipment, systems, and manufacturing area to service.

The integrated line includes a vial washer, depyrogenation tunnel, filling equipment, and isolator.

This is a hands-on field-execution role—not a remote oversight or strategy-only position. The consultant will develop and execute qualification protocols, perform equipment testing, resolve discrepancies, prepare final documentation, and work directly with client and vendor stakeholders.

What You’ll Do

• Support commissioning and qualification of an aseptic vial-filling line and isolator
  
• Support qualification of the vial washer, depyrogenation tunnel, filling equipment, and associated systems
  
• Review existing equipment and qualification documentation following an extended period of inactivity
  
• Evaluate system readiness and identify documentation, testing, or turnover gaps
  
• Develop, review, revise, and execute IOQ and PQ protocols
  
• Perform field walkdowns and verify equipment installation, configuration, instrumentation, and readiness
  
• Test equipment functions, operating sequences, alarms, interlocks, recipes, and automation interfaces
  
• Perform integrated line testing across the vial washer, depyrogenation tunnel, filling equipment, isolator, and supporting systems
  
• Support qualification activities associated with new-product modifications
  
• Document and resolve protocol discrepancies, deviations, punch-list items, and documentation gaps
  
• Prepare qualification reports and supporting turnover documentation
  
• Maintain clear traceability between requirements, testing, discrepancies, and final conclusions
  
• Coordinate testing with Engineering, Automation, Operations, Quality, Validation, vendors, and equipment suppliers
  
• Communicate execution progress, technical findings, risks, constraints, and readiness concerns
  
• Support operational-readiness and manufacturing-readiness activities
  
• Maintain complete, accurate, traceable, and inspection-ready documentation
  
• 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 or biotechnology manufacturing
  
• Direct experience supporting aseptic filling or sterile drug-product equipment
  
• Hands-on experience with aseptic filling lines, isolators, vial washers, depyrogenation tunnels, or comparable sterile-manufacturing equipment
  
• Experience developing, reviewing, and executing IOQ and PQ protocols
  
• Experience performing field walkdowns and verifying equipment installation, instrumentation, configuration, and readiness
  
• Experience testing equipment functions, alarms, interlocks, operating sequences, recipes, and automation interfaces
  
• Experience documenting and resolving protocol discrepancies and deviations
  
• Experience preparing qualification reports and supporting turnover documentation
  
• Strong understanding of cGMP requirements and validation-lifecycle principles
  
• Strong technical-writing and documentation-review skills
  
• Ability to perform hands-on field execution with limited supervision
  
• Ability to collaborate effectively with Engineering, Automation, Operations, Quality, Validation, vendors, and equipment suppliers
  
• Ability to work onsite in Bloomington, Indiana, five days per week throughout the engagement
  
• Bachelor’s degree in engineering, life sciences, or a related technical field, or equivalent relevant industry experience
  

What Will Set You Apart

• Experience restarting or recommissioning an aseptic filling line
  
• Experience returning equipment or manufacturing areas to GMP service following a long-term hold
  
• Experience supporting new-product introduction on existing filling equipment
  
• Experience with isolator qualification and integrated line testing
  
• Experience qualifying vial washers and depyrogenation tunnels
  
• Experience supporting sterile facility startups, expansions, remediation, or operational-readiness projects
  
• Experience with equipment automation, sequence testing, and system integration
  
• Prior CQV consulting or staff-augmentation experience
  
• Experience entering an active project and becoming productive with minimal ramp-up time
  
• Flexibility to travel or support future Pioneer assignments in different locations
  

Know Before You Apply

• This engagement requires full-time onsite work in Bloomington, Indiana.
  
• Remote and hybrid arrangements are not available for this project.
  
• Candidates must live within commuting distance or establish a reliable onsite presence before beginning the engagement.
  
• Any travel, temporary lodging, or relocation assistance will be determined individually and should not be assumed.
  
• This is a hands-on field role requiring direct protocol execution, equipment testing, discrepancy resolution, and detailed documentation.
  
• The initial engagement is expected to last approximately 8–12 months, but project timing may be extended, shortened, delayed, or changed.
  
• Schedule adjustments or additional hours may occasionally be required during critical execution periods.
  
• Future Pioneer assignments may involve different clients, locations, schedules, responsibilities, work arrangements, or travel requirements.
  

Please move forward only if you can fully commit to the onsite schedule, location, availability, and hands-on execution requirements.

What Working at Pioneer Requires

Working at Pioneer is different from working in a traditional, fixed position. You will be a Pioneer employee while operating within a client environment where priorities, schedules, responsibilities, and project needs 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.

Being client-centric does not mean simply agreeing with the client. It means understanding the client’s needs, communicating respectfully, raising concerns early, offering practical solutions, and protecting quality and compliance.

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 are members of the Pioneer team and 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 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.