Job Description

Commissioning, Qualification & Validation (CQV) Engineer – Mid-Level (3–7 Years)

Location: Pleasant Prairie, Wisconsin (on-site)

Duration: 18-month contract

Position Summary

Pioneer GMP Consulting is seeking motivated CQV Engineers with 3–7 years of experience to support a large-scale pharmaceutical manufacturing facility in Pleasant Prairie, Wisconsin. This role will provide hands-on CQV support across laboratories, utilities, aseptic processing areas, and building systems. The successful candidates will bring technical expertise and practical experience in commissioning, qualification, and validation to ensure facilities and systems are compliant, efficient, and ready for regulatory inspection.

Key Responsibilities

• Execute commissioning, qualification, and validation (CQV) activities for labs, clean utilities, aseptic processing equipment, and building systems.
  

• Author, review, and execute IQ/OQ/PQ protocols in alignment with GMP standards.
  

• Support project delivery through all phases of commissioning and qualification, from planning to operational handover.
  

• Collaborate with cross-functional teams including engineering, validation, and quality to troubleshoot issues and ensure project milestones are achieved.
  

• Document and report results clearly and in compliance with regulatory requirements.
  

• Ensure adherence to site safety procedures and industry best practices.
  

Requirements

• 3–7 years of CQV experience in the pharmaceutical, biotech, or life sciences industries.
  

• Strong understanding of GMP regulations, industry guidelines, and validation principles.
  

• Hands-on experience with laboratory equipment, clean utilities, and/or aseptic processing systems.
  

• Demonstrated ability to prepare and execute validation protocols.
  

• Strong technical writing, organizational, and problem-solving skills.
  

• Willingness and ability to work full-time, on-site in Pleasant Prairie, Wisconsin for the duration of the project.
  

Qualifications

• Proven CQV experience in laboratory, utility, or aseptic facility environments.
  

• Strong communication and teamwork skills for cross-functional collaboration.
  

• Ability to manage multiple tasks and deliverables in a fast-paced project setting.
  

Preferred Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or related technical discipline.
  

• Experience in greenfield or large-scale facility startup projects.
  

• Familiarity with risk-based validation approaches and regulatory agency inspection readiness.
  

• Exposure to both building commissioning and process equipment qualification.
  

Compensation & Benefits

Competitive compensation based on experience. Benefits and allowances may apply depending on assignment and client engagement.

Equal Opportunity Employer

Pioneer GMP Consulting is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We do not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, or any other legally protected status.

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