Senior Quality Assurance Engineer, Validations

Overview

Location: Johnson City, TN (Onsite)

Step into a highly visible leadership role where your validation expertise directly shapes the reliability, safety, and scalability of advanced manufacturing operations. This opportunity allows you to influence how innovative products move from development to commercial success, ensuring compliance, quality, and operational excellence across the site. You’ll be a trusted technical voice, driving smart, risk-based decisions in a fast-paced cGMP environment.

• Lead complex validation programs that impact products used globally
• Serve as a site-wide Subject Matter Expert with real decision-making authority
• Collaborate cross-functionally on high-priority launches and technology transfers
• Competitive compensation and annual performance bonus
• Comprehensive benefits including healthcare, 401k match, flexible PTO, and more

• Leading lifecycle validation for equipment, utilities, processes, and systems
• Authoring and executing IQ/OQ/PQ and risk-based qualification protocols
• Driving Validation & Verification Process (VVP) activities for new products
• Supporting change control, audits, and regulatory inspections
• Mentoring junior validation engineers and strengthening site standards

• Bachelor’s degree required
• Background in engineering, life sciences, or related discipline
• Strong knowledge of cGMPs and 21 CFR Parts 210, 211, and 11
• Expertise in lifecycle validation, CPV, and risk management
• Comfortable leading complex projects and influencing cross-functional teams

We’d love to see your resume, but we don’t need it to have a conversation. Send us an email to and tell me why you’re interested. Or, feel free to email your resume. Please include Job#19725
.