Commissioning and Qualification Expert
$98,700–$183,300 year
On-siteDurham, North Carolina, United States
Job Summary
Lead Commissioning & Qualification activities for GMP facilities, utilities, equipment, and systems across capital projects and operations. Develop qualification strategies, plans, protocols, and documentation to maintain GxP compliance while driving risk assessments and implementing mitigation strategies. Partner with cross-functional teams to deliver projects safely, oversee deviations and CAPAs, and establish engineering standards and SOPs. Manage vendor relationships, support internal audits and regulatory inspections, and provide leadership to build high-performing engineering teams. Monitor KPIs related to qualification status and project performance. This onsite role in Morrisville, NC involves 12-hour rotating shifts including at least one weekend day as the site approaches go-live.
Required Qualifications
- Bachelor's or Master's degree in Engineering or a related technical discipline
- Minimum 5 years of experience in engineering projects, C&Q, validation, or compliance within GMP environments
- Minimum 5 years of pharmaceutical industry experience supporting regulated manufacturing operations
- Strong knowledge of GMP, GxP, qualification lifecycle, validation principles, and regulatory expectations
- Proven project management experience delivering complex engineering projects safely and compliantly
- Demonstrated experience leading and influencing cross-functional teams, contractors, and external partners
- Strong problem-solving skills with experience managing deviations, investigations, risk assessments, and CAPAs
- Fluent English communication skills with the ability to effectively engage technical and business stakeholders
- Location in Morrisville, NC
- Onsite role
- Availability for 12-hour rotating shifts
- Availability for at least one weekend day
- Willingness to apply without relocation support
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