Exp Eng Process Engineering (1 of 2)

Johnson & Johnson•Wilson, NC

About The Position

The MSAT Process Engineer supports technology transfer, process lifecycle management, process analytics implementation, and manufacturing readiness for drug substance manufacturing processes in a GMP environment. The role contributes to the startup of a new manufacturing facility expanding production of biologic medicines in oncology, immunology, and neuroscience. Responsibilities include supporting product transfers and new technologies, lifecycle process validation, process improvement and investigations, manufacturing data integration and analysis, and implementation and monitoring of real-time multivariate analysis (RtMVA) and Raman models. The position also supports cross-functional projects, prepares technical and compliance documentation, and delivers training to operations and other associates. Travel may increase during startup activities; in steady state, expected travel is less than 10%.

Requirements

A minimum bachelor's degree in Life Sciences, Engineering, Biology, Biochemistry, or a related scientific field.
At least 4 years of experience in pharmaceutical manufacturing or another regulated industry, or 1+ years of experience 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 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, including the ability to communicate effectively with internal and external partners.
Strong computer proficiency, including Microsoft Office and Excel.
Ability to collaborate across organizational levels, manage assigned priorities, and work effectively in a dynamic environment.
Adaptability, flexibility, sound problem-solving skills, and organizational skills.
Ability to manage multiple project priorities with general supervision, collaborate effectively across the organization, and escalate technical issues appropriately.

Nice To Haves

Experience supporting drug substance or biologics manufacturing.
Experience participating in cross-functional teams and supporting projects involving technical complexity or change.
Familiarity with PAT tools, multivariate data analysis, CPV, or manufacturing data systems.
Experience with MES/DeltaV.

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 in and/or lead assigned cross-functional projects and investigations.