Senior Execution Systems Manager

Senior Execution Systems Manager – 2406205407W

Description

Johnson & Johnson is currently seeking a Senior Execution Systems Engineer to join our Johnson & Johnson Innovative Medicine Supply Chain organization located in Wilson, North Carolina .

While this role will ultimately support the site operations located in Wilson NC, this role will also be required to support the project phase across both design & construction. For the project design phase, the role will require you to be present with our design teams in the Greater Philadelphia region. Once the design phase is completed, this role will support the construction and operational start-up of the site. For this, you will be required to be on site in Wilson, NC. Based on your current location the hiring team will work with you to determine travel and relocation arrangements. In steady state, we expect travel to be less than 10%.

J&J is expanding our manufacturing capacity with $2 billion investment to support strong portfolio growth and continue delivering breakthrough innovation and transformational medicines for patients. The new facility will expand production of innovative biologic medicines in areas including oncology, immunology, and neuroscience. J&J’s significant supply chain investment ensures a resilient and reliable future supply of medicines to meet accelerating demand for our current portfolio of medicines and our future innovations.

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/.

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.

We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.

At Johnson & Johnson, we all belong.

The MAM (MAKE Asset Management) organization operates as one integrated team in the delivery of Engineering, Maintenance and Execution Systems solutions. We operate in a standard, coordinated and consistent manner in support of the current and future requirements of our Manufacturing and Manufacturing Science and Technology (MSAT) and in partnership with key internal/external network.

Execution Systems (ES) is a dedicated team of Automation professionals with various technical expertise, responsible for the implementation, validation, qualification and maintenance of the ISA-95 level 1 and 2 manufacturing automated systems and applicable interfaces and level 3 recipe content for the manufacturing facility. Ensure that automated systems are fit for intended use and follow applicable regulatory requirements (e.g. cG(a)MP) and company manufacturing standards throughout the entire system life cycle.

The Execution System Senior Manager drives strategy for design, investment, and implementation of automation and data integration capabilities in alignment with corporate vision. Leads Execution Systems team in the design, testing, and implementation of process automation systems. Establishes and maintains effective relationships with key stakeholders, software teams, and equipment vendors.

The selected candidate will manage highly technical individual contributors and Supervisors that execute automation projects and preventive and corrective maintenance of such systems. He/She will partner and collaborate with Operations, Quality, MSAT, and Digital Operations and Technology Systems (DOTS) among other teams, to improve the reliability of assets and the effective use of site resources. Accountable for fostering a positive work environment and a collaborative, “can-do” culture.

Key Responsibilities:

Manages a team of individual contributors and Supervisors and is accountable for conducting effective performance management, training and development, succession planning and meaningful career development conversations.

Directs department on implementation of process automation strategy to ensure systems and operational consistency across the platform.

Develops policies and procedures to ensure compliance with GMP, industry and organization standards.

Analyzes sites needs for improvements and upgrades of current automation systems and makes recommendations for changes that align with corporate vision and performance factors.

Provide direction to team’s execution to ensure key performance indicators are being met or exceeded.

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.

Provides input to capital projects and technical leadership in fulfilling automation requirements.

Provides direction to the team on leading automation projects, ensuring the creation of documentation on all equipment and system modifications and upgrades through approved change control methods.

Coordinates externally in order to guide and support the team with automation best practices and alternatives to current methodologies.

Manages Execution Systems/Automation related vendor contracts.

Monitors data system performance and conduct database administration.

Provides feedback to MSAT on changes required in Master Recipe to be incorporated into Equipment Class General Recipe (EC GR)

Provides feedback on equipment classes for incorporation into EC GR libraries.

Overseeing the creation of Functional Specification and Design Specification, Module testing, Factory Acceptance Test (FAT) and Site Acceptance Test (SAT) as well as conducting Integration testing (IQ) and Functional testing (OQ).

Management of system interfaces.

Oversees 24/7 Support System group.

Creates and maintains lifecycle documentation management for local applications (if any)

Participates in compliance inspections for topics related to Execution Systems / Automation

Implementation & maintenance of network configuration (in partnership with IT)

Overseeing activities for the creation of Master Recipe within the Control System and/ or MES

Provides feedback to Platform leads about site needs and priorities related to execution systems / automation activities.

Ensuring that Execution Systems are fit for intended use and compliant with internal standards and applicable regulations.

Qualifications

Required:

B.S. degree in Engineering, Science or related field.

A minimum of 8 years of experience in a manufacturing environment, ideally within the biopharmaceutical or pharmaceutical industry, including at least 4 years of proven experience in a pharmaceutical or GMP-regulated manufacturing environment in an Execution Systems, Automation, or IT role.

Proven ability to lead technical resources, manage multiple customer needs, prioritize tasks, and deliver results.

Strong working knowledge of cGMP’s for Execution Systems/Automation in an FDA regulated environment.

Strong influencing, partnering, collaboration, analytical, critical thinking and presentation (oral and written) skills.

Business and strategic acumen, with experience in project management and financial management.

In-depth Technical knowledge of S95 Level 1, 2 and 3 systems such as Emerson DeltaV, ABB IIT, MES PAS-X, OSI Pi, PLCs, IT Infrastructure & Hardware.

Good understanding of S95 level 4 systems and their capabilities such as ERP, Quality Systems, Data warehouses, etc.

In-depth understanding of the ISA S95 & S88 standards and how they should be used within the Global Supply Chain

Experience in configuration, programming and automation

People management experience

Preferred:

Good appreciation of Industry 4.0/IioT

This job posting is anticipated to close on 10/20/2024. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.

Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.

Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

Employees are eligible for the following time off benefits:

Vacation – up to 120 hours per calendar year

Sick time – up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year

Holiday pay, including Floating Holidays – up to 13 days per calendar year

Work, Personal and Family Time – up to 40 hours per calendar year

Additional information can be found through the link below.

For additional general information on Company benefits, please go to: – https://www.careers.jnj.com/employee-benefits

Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .

Primary Location NA-US-North Carolina-Wilson

Other Locations NA-US-North Carolina-Raleigh, NA-US-North Carolina-Goldsboro, NA-US-Pennsylvania-Horsham, NA-US-Pennsylvania-Philadelphia, NA-US-North Carolina-Greenville, NA-US-North Carolina-Rocky Mount

Organization Janssen Biotech, Inc. (6014)

Relocation Eligible: Yes – Within Country

Job Function Technology Operations Support

Req ID: 2406205407W