Piper Companies · 9 hours ago
Senior Validation & Quality Engineer
Clayton, NC
Full-time
Onsite
Senior Level
$60/hr - $70/hr
7+ years expPiper Companies is seeking a highly skilled and detail-oriented Senior Validation & Quality Engineer to support validation and compliance activities for advanced automation and intralogistics systems at a new greenfield pharmaceutical manufacturing site. This role is critical to ensuring an audit-ready validation program supporting fully automated material-handling operations across the facility.
Management Consulting
Hiring Manager
Katie Iverson
Responsibilities
Provide validation and technical support through preparation, execution, data analysis, and report writing for IQ, OQ, and PQ protocols
Author and maintain essential validation documents including PQMPs, Validation Plans (VPLs), Change Requests (CRs), and Configuration Item Lists (CILs)
Perform compliance and technical reviews/approvals of protocols and protocol data
Ensure all validation protocols and activities follow corporate, regulatory, and local requirements (FDA, ICH, GAMP5, 21 CFR Part 11, ISO)
Lead validation failure investigations and non‑conformities using structured root‑cause analysis techniques
Write, review, and maintain specifications, procedures, and supporting documentation needed to maintain equipment and system validated states
Participate in FAT/SAT, commissioning, and transition newly delivered equipment/automation systems into validation ownership
Support large‑scale intralogistics systems including ASRS, automated conveyors, AGVs/AMRs, and integrated IT/OT layers such as SCADA, WCS, and SAP
Identify process improvements and ensure readiness prior to systems entering change control
Provide oversight for contractors and assist with validation‑related budget tracking as required
Lead validation activities assigned by the project manager and act as SME for new systems
Maintain complete and audit‑ready documentation throughout all validation stages
Qualification
Required
BA/BS degree in Engineering, Computer Science, or relevant technical field (or equivalent experience)
Minimum 7 years of validation or quality experience in the pharmaceutical industry
Strong knowledge of regulatory standards including 21 CFR Part 11, GAMP5, ISO, and FDA/ICH guidance
Demonstrated experience conducting root‑cause analysis and solving complex technical problems
Ability to read, write, and understand complex equipment and product documentation
Strong leadership, communication, and project management abilities
Experience writing technical documentation based on equipment manuals
Strong understanding of GMP concepts required
Ability to manage multiple deadlines and adapt to changing process priorities
Strong change management experience
Preferred
MA/MS/MBS degree
3–5 years of experience with robotics, automation, and SAP
Prior pharmaceutical manufacturing experience
Novo Nordisk experience is a plus
Benefits
Full benefits including Cigna Health, Dental, Vision, and sick leave as required by law
Company
Piper Companies
At Piper, we obsess about the success of our customers and consultants.
501-1000 employees
H1B Sponsorship
Piper Companies has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (5)
2024 (1)
2023 (2)
2022 (2)
2021 (1)
Funding
Current Stage
Late StageLeadership Team
Justin Jordan
Founder and Chairman
Company data provided by crunchbase