CQV Engineer: Early‑Career Pharma Validation

Process Automation – Controls.Instruments.Validations, Inc.; Raleigh (NC); Hybrid; USD 90,000 - 140,000; Full time

Benefits offered by this job

Generous Paid Time Off

Health care premiums covered (90%)

HSA contributions

401(k) with company match

Job summary

Process Automation – Controls.Instruments.Validations, Inc. (PACIV) is seeking a CQV Engineer to support commissioning, qualification, and validation of manufacturing systems within regulated pharmaceutical environments.

You will work on high-impact capital projects and collaborate across engineering, automation, and validation teams in a hybrid Raleigh, NC setting. You will develop C&Q deliverables, apply CQV principles for regulatory compliance, and participate in FAT/SAT activities while

Qualifications

• Bachelor's degree in Biomedical or Chemical Engineering required.
• Strong understanding of validation principles and deliverables including requirements development, design, testing, and reporting.
• Demonstrated project management skills and ability to drive assignments to completion.

Responsibilities

• Develop and drive completion of Commissioning & Qualification deliverables, including validation plans, risk assessments, project strategies, user requirements, functional specifications, design specifications, testing, and final summary reports.
• Apply CQV principles to support project execution and regulatory compliance activities.
• Support capital projects involving API manufacturing equipment, filling operations, device assembly, packaging, facilities/utilities, and automation systems.
• Participate in design reviews, qualification reviews, testing strategy discussions, and project status meetings.
• Maintain validation documentation within electronic lifecycle management systems and support change management.

Skills

CQV knowledge

Project management

Communication skills

Education

Bachelor's degree in Biomedical or Chemical Engineering

Job description

Process Automation – Controls.Instruments.Validations, Inc. (PACIV) is seeking a CQV Engineer to support commissioning, qualification, and validation of manufacturing systems within regulated pharmaceutical environments.

You will work on high-impact capital projects and collaborate across engineering, automation, and validation teams in a hybrid Raleigh, NC setting. You will develop C&Q deliverables, apply CQV principles for regulatory compliance, and participate in FAT/SAT activities while