Exp Eng Process Engineering (1 of 2)

Johnson & Johnson Innovative Medicine•Wilson, NC

5d•Onsite

About The Position

The MSAT Process Engineer supports technology transfer, process lifecycle management, process analytics implementation, and manufacturing readiness activities for drug substance manufacturing processes in a GMP environment. The role supports Johnson & Johnson’s expansion of manufacturing capacity for biologic medicines in oncology, immunology, and neuroscience. The engineer supports product transfers, new technologies, digital tools, process validation, process improvement, investigations, manufacturing data integration, and site startup activities. The position also involves analyzing process data, maintaining and monitoring RtMVA and Raman models, preparing technical and compliance documentation, training associates, and contributing to cross-functional projects. The role may require increased travel during startup activities; expected travel in steady state is less than 10%.

Requirements

Bachelor’s degree or higher 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 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.