Principal Process Engineer Lab​/Administration Bldg

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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

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Are you interested in joining a team which provides innovative workplaces and delivers outstanding site solutions to our enable our J&J Enterprise to better serve our patients and customers? Apply now for this exciting role!

As part of the Global Process Engineering Team, the Principal Process Engineer - Lab/Administration Bldg. will serve as the recognized technical leader and be responsible for the end-to-end process engineering related to the laboratory/administration building for a new biotherapeutic drug product plant. This role is responsible for leadership for the design, implementation, and start-up of the state-of-the-art laboratory/administration building. This role is responsible for ensuring systems remain fit for intended use, aligned with business and compliance requirements, and managed throughout their lifecycle in a manner that protects quality, data integrity, and continuity of operations.

The position partners across laboratory operations, quality, commissioning & qualification, environmental health and safety, engineering and property services, and manufacturing science and technology to support healthcare innovation through system governance, user support, training, and continuous improvement.

Key Responsibilities:

* Serve as the designated process engineering lead for the biotherapeutic drug product plant laboratory and administration building design documents (User Requirement Specifications (URS), equipment data sheets, room cards, technical specifications, P&IDs, and process flow diagrams (PFDs)

* Evaluate and select equipment vendors by assessing technical capability, reviewing bid packages, and leading technical discussions, maintain accountability for the biotherapeutic drug product (DP) laboratory/administration building performance through project execution

* Develop system procedures, work instructions, inventories, training materials, and other controlled documentation in accordance with engineering and quality system requirements.

* Partner closely with key stakeholders to ensure complaint and effective system operation

* Promote and support data integrity, electronic records expectations, audit trail review processes, and good documentation practices across system use and administration.

* Coordinate vendor support and service requests during facility start-up activities to sustain performance, compliance, and user experience.

* Provide end-user support and training that enable consistent, standardized, and compliant system use across laboratory and administrative processes.

* Translate business needs into clear system requirements and contribute to process simplification, standardization, and continuous improvement initiatives.

* Support audits, inspections, and internal assessments by…