CQV Engineer (Bloomington, IN)

Pioneer GMP Consulting; Bloomington, Northern (IN, KY); On-site; USD 83,000 - 124,000; Full time

Benefits offered by this job

Travel reimbursement

Job summary

Pioneer GMP Consulting is seeking an experienced CQV Engineer to support the modification and restart of an aseptic vial‑filling line and isolator for a new product introduction. The project is 8–12 months, onsite in Bloomington, Indiana, with potential extension to other client engagements.

This hands‑on role involves IOQ/PQ, field walkdowns, protocol execution, discrepancy resolution, and close collaboration with Engineering, Quality, and Operations.

Qualifications

• 5+ years of CQV/commissioning/validation experience in GMP pharma/biotech manufacturing
• Direct experience supporting aseptic filling or sterile drug-product equipment
• Hands-on experience developing and executing IOQ and PQ protocols
• Experience testing equipment functions, alarms, interlocks, and automation
• Strong technical writing and qualification-report experience
• Ability to work hands-on in the field and independently

Responsibilities

• Support commissioning and qualification of aseptic vial-filling line and isolator
• Support qualification of vial washer, depyrogenation tunnel, filling equipment, and related systems
• Develop, review, and execute IOQ and PQ protocols
• Perform field walkdowns and verify installation, configuration, instrumentation, and readiness
• Coordinate testing with Engineering, Automation, Operations, Quality, Validation, vendors, and equipment suppliers
• Prepare qualification reports and turnover documentation
• Communicate progress, findings, risks, and readiness concerns

Job description

Bloomington, United States | Posted on 07/15/2026

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.

Job Description

CQV Engineer – Aseptic Filling Line and Isolator

*This is a full-time opportunity with Pioneer GMP Consulting—not a position limited to a single project. The initial client engagement is expected to last approximately 8–12 months and may be extended based on project needs. If the engagement concludes, Pioneer will work to transition the consultant to another client opportunity that aligns with their experience and capabilities.

About the Opportunity

Pioneer GMP Consulting is seeking an experienced CQV Engineer to support the modification and restart of an aseptic vial-filling line for the introduction of a new product.

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 as well as qualification activities necessary to return the existing equipment, systems, and manufacturing area to service.

The line includes a vial washer, depyrogenation tunnel, filling equipment, and isolator. This is a hands‑on field role requiring direct protocol execution, discrepancy resolution, strong documentation, and close collaboration with project 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
• Develop, review, and execute IOQ and PQ protocols
• Perform field walkdowns and verify system installation, configuration, instrumentation, and readiness
• Test equipment functions, operating sequences, alarms, interlocks, recipes, and automation interfaces
• Support qualification activities associated with new-product modifications
• Evaluate existing systems following long‑term hold and support their return to GMP service
• Document and resolve protocol discrepancies, deviations, punch‑list items, and documentation gaps
• Prepare qualification reports and supporting turnover documentation
• Coordinate testing with Engineering, Automation, Operations, Quality, Validation, vendors, and equipment suppliers
• Communicate execution progress, technical findings, risks, and readiness concerns
• Support operational‑readiness and manufacturing‑readiness activities as needed
• Represent Pioneer with professionalism, technical credibility, 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
• Experience with filling lines, isolators, vial washers, depyrogenation tunnels, or comparable aseptic equipment
• Hands‑on experience developing and executing IOQ and PQ protocols
• Experience testing equipment functions, alarms, interlocks, operating sequences, and automation
• Experience documenting and resolving protocol discrepancies and deviations
• Strong understanding of cGMP requirements and validation‑lifecycle principles
• Strong technical writing and qualification‑report experience
• Ability to perform hands‑on field execution and work independently
• Ability to work 100% onsite in Bloomington throughout the engagement

What Will Set You Apart

• Experience restarting or recommissioning an aseptic filling line
• Experience returning equipment or manufacturing areas to service following a long‑term hold
• Experience supporting new‑product introduction on existing filling equipment
• Experience with isolator qualification and integrated line testing
• Experience supporting sterile facility startups, expansions, or remediation projects
• Prior CQV consulting experience

Pioneer GMP Consulting provides quality, compliance, validation, 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

Competitive consulting rates commensurate with experience. Travel reimbursement and related expenses may apply based on engagement requirements.

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.