Site Automation Lead - Drug Product

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 Med Tech, 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.

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Job Function:
Technology Product & Platform Management
Job Sub Function:
Technology Operations Support
Job Category:
People Leader
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.

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The Automation Lead is the technical expert and will provide overall E2E Automation leadership to equipment and facility design of a new Drug Product (DP) aseptic manufacturing node. They will be accountable for all technical aspects of automation in the various areas (warehouse, laboratories, clean utilities, preparation, formulation/fill, optical inspection, and device assembly and packaging) ensuring the efficient and safe operational readiness and start-up of a new aseptic drug product manufacturing facility in compliance with cGMP and industry standards.

Apply today for this exciting opportunity to be part of our growing team!

The position is a key strategic business partner in working with J&J E&PS (Engineering & Property Services) to deliver the facility and process equipment design from conceptual through validation and operational readiness.

Key Responsibilities:

• Accountable for the creation of all automation and CSV (Computer System Validation) deliverables which define both functional and non-functional requirements during the project execution and at the time of handover for operational readiness.
• Lead the correct design and implementation of the overall automation & OT systems.
• Development and delivery of all automation specifications (user requirements, data sheets, technical specifications) and will assess vendor competency and capabilities, review and discuss bid documents, and be held accountable for project development and execution, including performance of the automation systems.
• Lead technical issue resolution on the automation systems and CSV during C&Q testing, the readiness of the system to start C&Q activities, and a key stakeholder in C&Q execution.
• Contributes to the project progress, helping to identify and expedite key activities across multiple business functions (Operations, Process Engineering, Quality, MSAT, Digital Operations and Technology Systems (DOTS), Procurement, and EHS among other teams.
• Maintaining a working knowledge of industry trends and benchmarking against internal/external practices
• Utilize data-driven insights and market intelligence to inform future decision making, stay informed on industry and regulatory trends, and adapt strategies accordingly to achieve excellent portfolio performance.
• Develop policies and procedures to ensure automation & CSV compliance with GMP, industry and organization standards
• Foster a culture of technical excellence, collaboration, and innovation to enable cross-functional learning and best practice sharing
• Maintain a culture of GMP compliance by ensuring that all site SOPs are strictly followed and that all deviations, events/Non-Conformances are reported, investigated, and corrected in a timely manner. Manage the completion of all assigned CAPA's (Corrective and Preventative Actions) and provide Subject Matter Experts (SMEs) support as necessary.
• Maintain assigned areas in a state of GMP and EHS audit readiness by ensuring compliance with Policies, SOP's (Standard Operating Procedures), good documentation practices, and…