Exp Eng Process Engineering (1 of 2)

Johnson & Johnson Co.; Wilson (NC); On-site; USD 110,000 - 140,000; Full time

Job summary

Johnson & Johnson is seeking a MSAT Process Engineer to support technology transfer, process lifecycle management, data analytics implementation, and GMP-ready manufacturing readiness for drug substance processes.

Join our Medicines Advanced Technology team in Wilson, NC, to drive process improvements, contribute to regulatory compliance, and collaborate across the organization on cross-functional projects and investigations.

Qualifications

• Minimum 4 years of experience in pharmaceutical manufacturing or regulated industry, or 1+ years with an advanced degree.
• Experience supporting technology transfer, manufacturing support, and lifecycle process validation.
• Knowledge of process analytics, data analysis, or statistical modeling.
• Familiarity with FDA/EMA GMP expectations and regulations.
• Ability to analyze data and draw meaningful conclusions for technical studies.
• Strong written and verbal communication with internal and external partners.
• Proficiency in Microsoft Excel and related software; MES/DeltaV is a plus.
• Ability to prioritize and work across teams in a dynamic environment.
• Adaptable and proactive in problem solving.

Responsibilities

• Support product transfers, new technologies, digital tools, and PPQ activities.
• Lead lifecycle process validation and site startup activities in GMP-compliant manner.
• Provide technical support for process improvement projects and investigations.
• Document and track MSAT-related exceptions, events, and nonconformances.
• Prioritize work aligned with manufacturing and project schedules.
• Analyze process data for trends, deviations, and variability.
• Perform statistical and multivariate analyses for investigations and continuous improvement.
• Coordinate training sessions for operations and associates as needed.
• Prepare analyses, protocols, reports, SOPs, CAPAs, change controls, and investigation records.

Skills

Tech transfer

Data analysis

Regulatory knowledge

Process analytics

Communication

Excel

Collaboration

Adaptability

Education

Bachelor's degree in Life Sciences/Engineering

Tools

MES/DeltaV

Job description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com .

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function

Supply Chain Engineering

Job Sub Function

Process Engineering

Job Category

Scientific/Technology

All Job Posting Locations

Wilson, North Carolina, United States of America

Job Description

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine

Johnson and Johnson is expanding our manufacturing capacity with $2 billion investment to support strong portfolio growth and continue delivering breakthrough innovation and transformational medicines for patients. The new facility will expand production of innovative biologic medicines in areas including oncology, immunology, and neuroscience. J&J's significant supply chain investment ensures a resilient and reliable future supply of medicines to meet accelerating demand for our current portfolio of medicines and our future innovations. Learn more at https://www.jnj.com/innovative-medicine

The MSAT Process Engineer will support technology transfer, process lifecycle management, process analytics implementation, and manufacturing readiness activities for drug substance manufacturing processes in a GMP environment.

Key Responsibilities

• Support product transfers, new technologies, digital tools, and PPQ activities in accordance with GMP requirements.
• Lead and execute assigned lifecycle process validation and support site startup activities in compliance with applicable regulations and company procedures.
• Provide technical support for process improvement projects, and investigations.
• Document, track, and support resolution of MSAT-related exceptions, events, and nonconformances.
• Prioritize assigned work in alignment with manufacturing and project schedules.
• Support manufacturing data integration and analyze process data for trends, deviations, and variability.
• Perform statistical and multivariate analyses to support investigations, CPV, and continuous improvement.
• Lead and execute the transfer, documentation, maintenance and performance monitoring of RtMVA and Raman models in partnership with the global team and in compliance with GMP requirements.
• Coordinate and conduct training sessions for operations and other associates as needed.
• Prepare analysis summaries, protocols, reports SOPs, CAPAs, change controls, and investigation records for review and approval.
• Author department procedures as needed.
• Gather information from internal and external partners to support technical reports and project deliverables.
• Complete all required role and compliance training.
• Participate and/or lead assigned cross-functional projects and investigations.

Qualifications

Education

A minimum bachelor's degree in Life Sciences, Engineering, Biology, Biochemistry, or a related scientific field is required.

Experience and Skills

Required

• A minimum of 4 years of experience in pharmaceutical manufacturing or another regulated industry, or 1+ years with an advanced degree (MS, MBA, Ph.D., or equivalent).
• Experience supporting technology transfer, manufacturing support, and lifecycle process validation.
• Working knowledge of process analytics, data analysis, or statistical modeling.
• Knowledge of applicable industry regulations and GMP expectations, including those of the FDA, EMA, and other relevant authorities.
• Ability to collect, process, and analyze data using established methods and draw meaningful conclusions for technical studies.
• Strong verbal and written communication skills, with the ability to communicate effectively with internal and external partners.
• Strong computer proficiency, including Microsoft Office and Excel; experience with MES/DeltaV is beneficial.
• Ability to collaborate across organizational levels, manage assigned priorities, and work effectively in a dynamic environment.
• Adaptable and flexible, with sound problem