Automation Engineer

Staff Automation Engineer

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.

We are searching for the best talent for Staff Automation Engineer to be based in Raritan, NJ.

The Staff Automation Engineer will engage in collaboration with multi-functional teams to implement solutions across automation platforms deployed in Raritan.

Key responsibilities:

• Lead and execute technical development, qualification, planning, and lifecycle activities for process automation systems. Configure interfaces and ensure system compliance to local and global standards.
• Drive operational technology change, serving as the business SME and product owner for process automation, PIMS OSI-PI, Rockwell PLC, DeltaV DCS, and Siemens Desigo EMS.
• Be the single point of contact for ISA-95/88 L0-L2 automation systems deployed at the Raritan site. Define, monitor and report-out on system performance and business metrics.
• Ensure all aspects user requirement specifications and all applicable objectives are met to maintain the automation platforms (e.g. backup, disaster recovery, user administration etc.).
• Author and execute validation test protocols within the electronic document validation system (Kneat) per GxP. Coordinate periodic system reviews for the deployed automation.
• Hold and support change controls, non-conformances, and corrective and preventive actions to ensure the quality commitments are met relative to automation.
• Use industry experience to identify continuous improvement opportunities. Lead and steer automation improvement projects and assessments for new technology introduction.
• Be responsible for the oversight and effective delegation of automation development activities to external managed service providers and internal partners, as necessary.
• Support the OT cybersecurity workstream for the site, as necessary.
• Support the Raritan site readiness for FDA and health authority audits, as necessary.
• Establish effective relationships with Operations, Manufacturing Science and Technology, Quality, IT, Facilities, and Global teams within both Johnson & Johnson and Legend Biotech.

Qualifications:

Education:

• A minimum of a Bachelor's degree is required. A Master's degree in Systems Engineering, Mechatronic, Computer Science, or a related field; advanced degrees (e.g., MBA) is preferred.

Experience and Skills:

Required:

• A minimum 7-8 years of relevant professional experience within a regulated pharmaceutical or biotechnology manufacturing environment is required.
• In-depth technical knowledge of operational technology; ISA-95/88 L0-L2 systems, including instrumentation, Rockwell PLC/SCADA, OSI-PI PIMS, DeltaV DCS, and Desigo EMS.
• Experience integrating L2 and L3 enterprise systems (e.g. SCADA to PAS-X MES).
• Extensive experience in merging OT and IT systems, and defining fit for purpose hardware and software design specifications according to ISPE GAMP-5.
• Validated practical knowledge of maintaining cGxP regulations related to CSV including FDA 21 CFR Part 11 and EU Annex 11.
• Must have a strong emphasis on driving accelerated technology adoption and moving the needle. Experience with real-time data integration to steer optimizations for manufacturing process is preferred.
• Excellent interpersonal skills (written, verbal, and presentation). Must have the ability to influence and make data-driven decisions according to the J&J Credo.

Preferred:

• Appreciation of Pharma 4.0, digital transformation, IOT, cybersecurity and data.
• Experience with Cell Therapy Chain of Custody (COC) and Chain of Identity (COI) systems.
• Certification in Process and/or Project Management, e.g., Lean Six Sigma, PMP, Agile PM.
• Knowledge of Data Lake and Data Visualization Tools; e.g, PowerBI, Tableau, PI Vision.
• Experience engaging in FDA and/or Health Authority regulatory audits and inspections.

Required Skills:

Preferred

Skills:

Artificial Intelligence (AI), Controls Compliance,…