Exp Eng Process Engineering (1 of 2)

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.

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.

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-solving and organizational skills.
• Ability to perform multiple projects priorities with general supervision, effectively collaborate across the organization and escalate technical issues appropriately.

Preferred:

• 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.

Other: This role may require periods of increased travel to support startup activities based on functional needs and project timelines. In some cases, this could involve frequent travel and/or short-term stays with vendors, sister companies, or partners. In steady state, we expect travel to be <10%.