Senior CQV Engineer

About the role

Join a leading life sciences consulting and engineering organisation supporting pharmaceutical and biotechnology manufacturers on commissioning, qualification, and validation projects. This role is ideal for validation professionals looking to take ownership of qualification activities, client interactions, and project delivery within GMP-regulated environments. Position located in Columbus, OH. No sponsorship or corp-to-corp available.

Responsibilities

• Design validation and qualification plans
• Conduct risk and impact assessments
• Author, review, and execute IQ/OQ/PQ documentation
• Execute testing protocols and validation activities
• Support software verification and automated system testing
• Manage qualification, validation, and change control records
• Collaborate with Engineering, Manufacturing, Quality, and Operations teams
• Mentor junior team members
• Communicate project updates and technical findings to clients

Requirements

• 4-6+ years of CQV, Validation, or Qualification experience
• Experience within GMP-regulated pharmaceutical or biotech environments
• Hands-on experience with IQ/OQ/PQ activities
• Strong understanding of GMP and Good Documentation Practices (GDP)
• Experience with risk assessments and change control
• Strong technical writing and documentation skills
• Ability to work independently and manage multiple priorities
• Strong communication and client-facing skills

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Chemistry, Biotechnology, or a related field
• Experience authoring and executing validation documentation
• Knowledge of URS, qualification protocols, and validation life cycle activities
• Experience with equipment, process, system, or software qualification
• Experience supporting automated systems and software verification preferred
• Previous mentoring or project leadership experience is a plus

Pay

Base salary: $80,000 - $110,000

Benefits

• Medical, Dental, and Vision Coverage
• 401(k) with Company Match
• Paid Time Off and Holidays
• Professional Development & Career Growth Opportunities