Requirements
- Bachelor’s degree in engineering or science related field
- Minimum 8 plus years of direct industry experience in a GxP-regulated environment with a focus on Quality Engineering; including demonstrated experience serving as a Quality SME during regulatory inspections and/or audits.
- Demonstrated experience in qualification, validation, change control, and Quality Engineering activities.
- Must be able to work in an office and regulated manufacturing environment, including construction/start-up phases, with appropriate PPE.
Nice to Have
- Master’s degree in engineering or science related field
- Direct experience with PM and Calibration systems, equipment lifecycle management, or CMMS platforms
- Familiarity with DS single-use biologics operations or greenfield startup environments
Benefits
- 401K with company matching
- Annual Bonus Program (Sales Bonus for Sales Jobs)
- Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days
- Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)
- HSA & FSA Programs
- Well-Being and Work/Life Programs
- Long-Term Incentive Program (subject to job level and performance)
- Life & Disability Insurance
- Concierge Service
- Pet Insurance
- Tuition Assistance
- Employee Referral Awards
Work Arrangement
On-site
Additional Information
- This position is based on-site in Sanford, NC. Other standard company policies for flexible work arrangements do not apply to this role. This is not a hybrid or remote role.
- This role may require travel up to 5% domestic and typically limited international travel.
