Automation & IT CQV Senior Engineer (Pharmaceutical Manufacturing)

Location: Clayton, NC, United States. Unrestricted authorization to work in the United States is required; employer-sponsored work authorization is not available.

Company

hirify.global delivers compliant, production-ready pharmaceutical systems from design through handover.

What you will do

• Plan, execute, and document design reviews, qualification, IQ, OQ, PQ, process validation, and commissioning activities.
• Author and review validation plans, specifications, risk assessments, traceability matrices, protocols, reports, and electronic validation records.
• Support CQV activities for pharmaceutical manufacturing equipment, automation, manufacturing IT, laboratories, facilities, utilities, and GMP systems.
• Investigate deviations and engineering changes, support change controls, and assess validation impacts.
• Coordinate deliverables, risks, constraints, escalations, FAT activities, suppliers, customers, Quality, and project stakeholders.
• Serve as a technical SME or project workstream lead, review work, coach junior colleagues, and contribute to customer solutions.

Requirements

• Bachelor’s or Master’s degree in Engineering, Automation, Computer Science, Life Sciences, or a related discipline, or equivalent relevant experience.
• 5+ years of commissioning, qualification, or validation experience in pharmaceutical, biotechnology, medical-device, or other regulated manufacturing.
• Strong knowledge of GMP and risk-based validation, with familiarity with FDA expectations, EU Ahirify.globalx 15, GAMP 5, and applicable procedures.
• Experience independently authoring, reviewing, and executing clear, traceable validation documentation.
• Experience with pharmaceutical equipment, automation or manufacturing IT, laboratories, facilities, or utilities.
• Ability to work independently, manage complex priorities, communicate clearly, solve practical problems, collaborate cross-functionally, and raise risks early.

Nice to have

• Experience with DeltaV, Syncade, SCADA, PLC, PAS-X, BMS, or similar pharmaceutical automation and manufacturing systems.
• Experience with electronic validation and quality systems such as TIMS (HP ALM) and Veeva QualityDocs/Vault Quality.
• Experience supporting FAT, system modernization, lifecycle replacement, or larger capital projects.
• Experience serving as a technical SME or leading defined CQV workstreams.

Culture & Benefits

• Competitive salary with annual adjustment increases.
• 160 hours of PTO, prorated from the hire date, plus 14 paid holidays.
• Health, dental, and vision insurance from day one.
• 8% guaranteed 401(k) company contribution.
• 14 weeks of paid parental leave, company-paid life and disability insurance, and employee referral bonuses.

Hiring process

• Applications are accepted through the online system only.
• Interviews are scheduled on a rolling basis.
• Application deadline: 10/23/2026.