Senior Process Engineer – Onsite Validation Leader

Johnson & Johnson Innovative Medicine; Jacksonville (TX); On-site; USD 105,000 - 145,000; Full time

Job summary

Johnson & Johnson Innovative Medicine in Jacksonville, FL is seeking a Senior Process Engineer to lead complex manufacturing initiatives within a GMP/ISO/FDA regulated environment. The role focuses on end-to-end change control, validation, and cross-functional delivery to improve safety, quality, and efficiency.

The ideal candidate will have a bachelor’s in engineering with 4–6+ years in manufacturing/regulated settings and hands-on experience with IQ/OQ/PQ, DOE, and continuous improvement.

Qualifications

• Bachelor’s degree in Engineering or related technical discipline.
• Typically 4–6+ years of relevant engineering experience in manufacturing/regulated environments.
• Demonstrated experience leading projects of moderate-to-high complexity (cross-functional scope, qualification/validation, change control).

Responsibilities

• Leads and executes complex engineering and/or change control projects.
• Applies project management methodologies to define scope, schedule, resources, risks, and deliverables.
• Performs concept analysis and supports development of capital/expense justifications.
• Participates in technical design reviews; translates requirements into robust specifications.
• Leads validation strategy and execution (IQ/OQ/PQ), including protocol authoring and deviation management.
• Identifies and implements process/equipment improvements to boost efficiency and safety.

Skills

Project management

Cross-functional teamwork

Statistical analysis

Problem solving

Leadership

Education

Bachelor’s degree in Engineering

Job description

Johnson & Johnson Innovative Medicine in Jacksonville, FL is seeking a Senior Process Engineer to lead complex manufacturing initiatives within a GMP/ISO/FDA regulated environment. The role focuses on end-to-end change control, validation, and cross-functional delivery to improve safety, quality, and efficiency.

The ideal candidate will have a bachelor’s in engineering with 4–6+ years in manufacturing/regulated settings and hands-on experience with IQ/OQ/PQ, DOE, and continuous improvement.