Validation Engineer
Performance Validation · Raleigh, NC · 2 mo ago
Quality AssuranceFull-time
Responsibilities
- Develop a sound understanding of how to properly implement technical, quality, and scientific principals necessary to meet industry and customer requirements
- Work in a team environment to meet defined objectives based on established timelines
- Develop verification/qualification deliverables including but not limited to Requirements Documents, Functional and Design Specifications, Test Protocols (IQ/OQ/PQ), and Summary Reports
- Execute test protocols, including identification and resolution of non-conformances/deviations
- Track and manage change control activities for multiple concurrent projects
Requirements
- Educational background: BS/BA degree and 1-2 years in pharmaceutical or other regulated industry experience directly related to pharmaceutical validation
- Bachelor's degrees in Biomedical Engineering, Chemical Engineering or Mechanical Engineering preferred
- Experience: Change and Deviation Management, Strong interpersonal skills, Must interact confidently with clients, other contractors, and employees, Excellent oral and written communication skills and high attention to detail, Cleaning, Sterilization, and Decontamination Validation experienced preferred, Device Assembly and Packing experience preferred
What we have to offer
- Competitive base salary
- Biannual profit share
- Employee stock ownership program
- 401(k) company match
- Flexible time off policy
- Paid Parental Leave
- Medical, vision, and dental coverage
- Disability and life insurance
- Cellphone stipend
- Growth opportunities
- Company-sponsored team building outings
- A collaborative work environment
- Work/life harmony