CQV Engineer II

Arcadis; Cary (NC); On-site; USD 85,000 - 125,000; Full time

Job summary

DPS Group, Inc. in Cary, NC is seeking a CQV Engineer II to lead commissioning, qualification, and validation activities for pharmaceutical and biopharmaceutical facilities, utilities, and equipment.

The ideal candidate will have strong knowledge of GEP, cGMP requirements, and CQV lifecycle execution. This role will be based in Cary, NC and candidates must be willing to travel for extended periods of time based on assigned projects, with independence in developing and executing validation

Qualifications

• CQV experience in regulated pharma/biotech environments.
• Strong understanding of CQV lifecycle and regulatory expectations.
• Excellent technical writing and documentation review skills.

Responsibilities

• Develop, review, and execute CQV deliverables per project standards and regulatory requirements.
• Lead commissioning tests, IQ/OQ/PQ, FAT/SAT protocols and reports.
• Perform system walkdowns, punch lists, redline updates, and turnovers.
• Support startup, commissioning activities, and testing coordination.
• Mentor junior CQV engineers and contribute to process improvements.
• Coordinate planning, estimation, and resource loading for CQV activities.

Skills

CQV

Validation

cGMP

Technical writing

Stakeholder comms

Education

Bachelor's in Engineering

Tools

Kneat

Veeva

Microsoft Word

Excel

Job description

Our Cary, NC CQV team is growing and looking to add additional CQV Engineer II resources to the team.

In this role, you will lead commissioning, qualification, and validation (CQV) activities for pharmaceutical and biopharmaceutical facilities, utilities, and equipment. The ideal candidate will have a strong understanding of GEP, cGMP requirements, and CQV lifecycle execution.

This position requires the ability to independently develop and execute validation deliverables, collaborate with cross-functional teams, support project planning, and ensure compliant project delivery. The CQV Engineer II will work with minimal supervision, mentor junior team members, and play a key role in both field execution and documentation activities.

This role will be based in Cary, NC and candidates must be willing to travel for extended periods of time based on assigned projects.

Key Responsibilities

• Develop, review, and execute CQV deliverables in accordance with project standards and regulatory requirements:
• Commissioning test protocols and checklists
• Qualification protocols (DQ/IQ/OQ/PQ)
• Standard Operating Procedures (SOPs) and Work Instructions
• Impact assessments and system risk evaluations
• FAT and SAT protocols and summary reports
• Turnover packages and validation summary reports
• Lead and execute field-based CQV activities:
• Attend and support FATs and SATs as required
• Perform protocol execution and troubleshooting
• Conduct system walkdowns, punch listing, and redline updates
• Support startup and commissioning activities
• Identify and resolve issues during testing and coordinate retesting as needed
• Provide guidance and mentorship to junior CQV engineers and team members
• Support development and improvement of CQV processes, templates, and tools
• Contribute to planning efforts, including estimating and resource loading as needed

Skills & Qualifications

• Bachelor's degree in Engineering (Chemical, Mechanical, Industrial, related field) or equivalent hands on experience
• 4-6 years of CQV, validation, or relevant engineering experience in a regulated industry (pharmaceutical, biotech, medical device, etc.)
• cGMP regulations and FDA expectations
• Commissioning and qualification lifecycle
• Proficient in Microsoft Word and Excel (data tracking, documentation, and reporting)
• Experience with document management systems (e.g., Kneat, Veeva, or similar) preferred
• Strong technical writing and documentation review skills
• Ability to work independently and manage multiple priorities
• Strong communication and stakeholder coordination skills
• Detail-oriented with a structured and disciplined approach to work
• Ability to travel based on project needs
• Comfortable working in both office and field environments
• Capable of operating independently while supporting team objectives

The Company

DPS Group, Inc. is proudly part of the Arcadis Group of Companies and is a global EPCM firm offering full-service solutions within the Life Sciences (pharmaceutical, biotechnology, and medical technology) and Advanced Technology (semiconductor, data center, and solar) industries. DPS is dedicated to delivering successful projects with a 'client-first' mentality and personal touch across a range of market sectors: Project and Program Management, Procurement, Design, Construction Management, Health and Safety Management, Commissioning, Qualification, and Start-up.

DPS Engineering Inc. is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. DPS does not discriminate in employment opportunities or practices on the basis of race, color, religion, gender, national origin, age, sexual orientation, gender identity, disability, veteran status or any other characteristic protected by country, regional or local law.