CQV Engineer II

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

You can get further details about the nature of this opening, and what is expected from applicants, by reading the below.
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 ResponsibilitiesDevelop, review, and execute CQV deliverables in accordance with project standards and regulatory requirements:Commissioning test protocols and checklistsQualification protocols (DQ/IQ/OQ/PQ)Standard Operating Procedures (SOPs) and Work InstructionsImpact assessments and system risk evaluationsSpecifications (URS, FRS, DDS, etc.)FAT and SAT protocols and summary reportsTurnover packages and validation summary reportsLead and execute field-based CQV activities:Attend and support FATs and SATs as requiredPerform protocol execution and troubleshootingConduct system walkdowns, punch listing, and redline updatesSupport startup and commissioning activitiesIdentify and resolve issues during testing and coordinate retesting as neededProvide guidance and mentorship to junior CQV engineers and team membersSupport development and improvement of CQV processes, templates, and toolsContribute to planning efforts, including estimating and resource loading as needed
Skills & QualificationsBachelor’s degree in Engineering (Chemical, Mechanical, Industrial, related field) or equivalent hands on experience4–6 years of CQV, validation, or relevant engineering experience in a regulated industry (pharmaceutical, biotech, medical device, etc.)cGMP regulations and FDA expectationsGood Engineering Practices (GEP)Commissioning and qualification lifecycleProficient in Microsoft Word and Excel (data tracking, documentation, and reporting)Experience with document management systems (e.g., Kneat, Veeva, or similar) preferredStrong technical writing and documentation review skillsAbility to work independently and manage multiple prioritiesStrong communication and stakeholder coordination skillsDetail-oriented with a structured and disciplined approach to workAbility to travel based on project needsComfortable working in both office and field environmentsCapable of operating independently while supporting team objectives
The CompanyDPS 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. xzbcwsv
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.
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