Experienced Engineer Process Engineering- Thermal Validation

Johnson & Johnson seeks an experienced thermal validation engineer for its Manufacturing Science and Technology team in Wilson, North Carolina. The role focuses on autoclave cycle development, equipment qualification, and process validation activities for biotherapeutic manufacturing in a newly expanded facility.

Responsibilities

• Conduct autoclave cycle development, performance qualifications, and controlled temperature equipment requalifications
• Develop manufacturing science and technology documentation including strategies, plans, protocols, and technical reports
• Execute thermal validation protocols and field work in compliance with regulatory and company requirements
• Review, approve, and coordinate MSAT documentation with colleagues and cross-functional teams
• Track, resolve, and report on exceptions, nonconformances, and change control activities during validation activities

Requirements

• Bachelor's degree in life sciences, engineering, biology, biochemistry, or related field
• Minimum 3 years pharmaceutical manufacturing industry experience
• Minimum 2 years biological thermal validation experience
• Excellent verbal and written communication skills
• Proficiency with MS Office, Excel, SAP, and technical documentation
• Knowledge of FDA, HPRA, EMEA regulations and GMP requirements
• Ability to work independently with minimal supervision