Site Automation Lead - Drug Product

Johnson & Johnson Innovative Medicine•Wilson, NC

26d•Onsite

About The Position

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 MedTech, 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. Learn more at https://www.jnj.com/innovative-medicine 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.

Requirements

Minimum of a Bachelor’s/University or equivalent degree is required ; focused degree in Engineering, Science or related field; preferred
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.

Nice To Haves

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.
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

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 housekeeping standards.
Oversees 24/7 Support System group.
Creates and maintains lifecycle documentation management for local applications (if any).