Aseptic DP Process Engineering Leader

NCBiotech; Wilson (NC); On-site; USD 120,000 - 170,000; Full time

Job summary

Johnson & Johnson in Wilson, North Carolina, seeks a Sr. Principal Engineer, Process Engineering System Owner – Aseptic DP Compounding to lead end-to-end aseptic drug product systems within a biotherapeutics setting.

You will design and implement two aseptic DP compounding suites, manage vendor selection, lead FAT/SAT/C&Q, and drive commissioning, qualification, and start-up while ensuring compliance with cGMP and regulatory standards.

Qualifications

• Minimum of a bachelor's degree in engineering; chemical engineering preferred.
• 10+ years in aseptic drug product compounding in a biotherapeutics cGMP environment.
• Experience leading capital projects and cross-functional teams.
• Proven ability to design and implement single-use technology and stainless steel tanks.
• Strong problem-solving, communication, and leadership skills.

Responsibilities

• Develop and deliver aseptic, biotherapeutic DP compounding equipment specifications and drawings.
• Lead design and development of two aseptic DP compounding suites.
• Lead FAT, SAT, commissioning and qualification activities and start-up.
• Coordinate with Manufacturing, Facilities, Quality, Procurement, and external vendors.
• Ensure compliance with regulatory standards and project timelines.

Skills

Agile Decision Making

Coaching

Cross-Functional Collaboration

Technical Credibility

STEM Application

Project Schedule

Process Engineering

Lean

Industrial Hygiene

CAPA

Education

Bachelor's Degree in Engineering

MS or MBA preferred

Tools

P&ID

PFDs

Single-Use Technology Design

Job description

Johnson & Johnson in Wilson, North Carolina, seeks a Sr. Principal Engineer, Process Engineering System Owner – Aseptic DP Compounding to lead end-to-end aseptic drug product systems within a biotherapeutics setting.

You will design and implement two aseptic DP compounding suites, manage vendor selection, lead FAT/SAT/C&Q, and drive commissioning, qualification, and start-up while ensuring compliance with cGMP and regulatory standards.