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Senior Execution Systems Manager
1 month ago
Johnson & Johnson is seeking a highly skilled Senior Execution Systems Manager to join our Innovative Medicine Supply Chain organization in Wilson, North Carolina.
Job Summary:We are looking for a seasoned professional with expertise in automation systems, process control, and manufacturing execution systems to lead our Execution Systems team. The successful candidate will be responsible for driving strategy, implementing automation solutions, and ensuring compliance with regulatory requirements.
Key Responsibilities:- Lead the Execution Systems team in the design, testing, and implementation of process automation systems.
- Develop and implement policies and procedures to ensure compliance with GMP, industry, and organizational standards.
- Analyze site needs for improvements and upgrades of current automation systems and make recommendations for changes.
- Provide direction to the team on leading automation projects, ensuring the creation of documentation on all equipment and system modifications and upgrades.
- Coordinate externally to guide and support the team with automation best practices and alternatives to current methodologies.
- Manage Execution Systems/Automation related vendor contracts.
- Monitor data system performance and conduct database administration.
- Provide feedback to MSAT on changes required in Master Recipe to be incorporated into Equipment Class General Recipe (EC GR).
- Oversee 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.
- Oversee 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.
- 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.
- Good appreciation of Industry 4.0/IoT.
Johnson & Johnson offers a competitive salary, comprehensive benefits package, and opportunities for professional growth and development.
As a member of the J&J Family of Companies, you will have access to a wide range of benefits, including medical, dental, and vision insurance, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
Employees may also be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
Additional information can be found through the link below.
For additional general information on Company benefits, please go to: https://www.jnj.com/careers/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 https://www.jnj.com/careers/whole-health
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
Relocation Eligible: Yes - Within Country
Job Function Technology Operations Support
Req ID: W