Site Automation Lead Drug Product

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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.

Learn more at 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 CAPAs (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 SOPs (Standard Operating Procedures) good documentation practices and housekeeping standards.
• Oversees 24/7 Support System group.
• Creates and maintains lifecycle documentation management for local applications (if any).

Qualifications

Education:

• Minimum of a Bachelors/University or equivalent degree is required ; focused degree in Engineering Science or related field; preferred

Experience and Skills:

Required:

• A minimum of 8 years of experience in a manufacturing environment preferably within the biopharmaceutical or pharmaceutical industry including at least
• A minimum 2 years of experience in an Automation or IT role within a pharmaceutical or GMP-regulated manufacturing environment.
• In-depth knowledge of automation systems including Emerson DeltaV OSI Pi Siemens PLCs and IT infrastructure & hardware.
• Experience with Process Automation Systems (PAS) Building Automation Systems (BAS) and PLCs.
• Strong understanding of Industrial Automation Networks and Communication Protocols.
• Familiarity with S95 level 4 systems such as ERP Quality Systems Data Warehouses and CDL.
• Expertise in ISA S95 and S88 standards and their application within the Global Supply Chain.
• Knowledge of cGMP regulations related to Automation & Computer System Validation (CSV) including 21 CFR Part 11 and EU GMP Annex 11 in an FDA regulated environment.
• Proficiency with OSI PI Historian and Koerber (Werum) MES.
• Expert level knowledge of change management and change control process for highly integrated recipe and IT systems.
• Demonstrated ability to lead technical resources manage multiple customer needs prioritize work and deliver results.
• Influencing skills partnering and collaboration skills analytical skills critical thinking and excellent oral and written presentation skills are required.
• Business and strategic acumen including project management and financial management experience required.
• Experience in supervision/management of people and resources.

Preferred:

• Process knowledge for Drug Product Aseptic Processing and Bio Processing Support functions.
• Understanding of GAMP 5 and other recognized industry standard methodologies.
• Good appreciation of Industry 4.0/IIoT.
• Talent Development & Organizational Leadership
• Actively participate in inclusion initiatives to build a well-rounded high performing automation team
• Experience developing and mentoring engineering team members to ensure a strong talent pipeline
• Process Knowledge and Industry Benchmarking

Other:

• The position will be based out of Wilson NC. However the design of the facility will likely occur at an Engineering firm with frequent travel (> 50%) required until the project design shifts to the plant site of Wilson NC

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Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation external applicants please contact us via internal employees contact AskGS to be directed to your accommodation resource.

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