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Job Function:

Supply Chain Engineering

Job Sub Function:

Repair & Maintenance Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Wilson, North Carolina, United States of America

Job Description:

Johnson & Johnson is currently seeking Senior Maintenance Reliability Engineer to join our MAKE Asset Management Organization located in US Large Molecule Drug Substance Site 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. 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 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

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.

The Senior Maintenance Reliability Engineer ensures bioprocess equipment and processes operate at optimal levels and meet the needs of the organization. The incumbent will focus on increasing equipment uptime, reliability, and efficiency in support of Johnson and Johnson pharmaceutical manufacturing equipment

Key Responsibilities:

• Support the Reliability and Asset Management strategy, roadmap, program, and execution.

• Support creation and establishment of maintenance strategies that drive safe, reliable, effective, and efficient maintenance operations, including asset criticality analysis, asset replacement plan, root cause problem solving, etc.

• Support governance, processes and capabilities to deliver plant reliability. This includes guidance of cross-departmental project teams to develop and deploy lifecycle management, reliability centered maintenance programs, 5-year CapEx Asset Replacement Planning for the Long Range Financial Plan (LRFP) and reliability components of the Site Asset Masterplans (SAMP).

• Deploy business analytic tools for continuous improvement and risk management as part of the Reliability strategy, including FRACAS, FMECA, HAZOP, etc.

• Develop and implement reliability training programs for maintenance staff

• Responsible for exposing and solving critical reliability issues and driving improvements in maintenance processes.

• Actively looks for opportunities to improve the availability and performance of systems.

• Set reliability requirements for equipment, subsystems, and assemblies

• Establish reliability metrics/KPI's monitoring performance & improvement PM/CM ratio, MTBF, MTTR, etc.

• Supports the bioprocess manufacturing unit by providing technical support on equipment and reliability issues

• Conduct in-depth equipment reliability data analyses

• Lead Root Cause Problem Solving exercises and actively support the compliance program including Non-Conformances/Investigations, CAPA Review Board, and Audits.

• Coordinate investigations of equipment reliability related incidents that may occur in responsible areas.

• Support managing Plant MAM compliance programs (PM, predictive analysis, equipment failures, etc.)

• Provide guidance for acceptance testing and inspections on new equipment

• Liaison with bioprocess and maintenance teams to ensure fielded data is reconciled and corrective action is implemented

• Collaborate with the bioprocess team on new product introductions involving design and sourcing of custom equipment

• Analysis of reliability data to identify adverse performance trends and improvement opportunities

• Creates equipment risk-based mitigation plans

• Develop and implement new maintenance procedures (SOPs, PM, job aids, etc.)

• Design and implement new procedures for monitoring and testing equipment.

• Collaborate with other departments to ensure reliability is integrated into all aspects of the organization

• Participate in PM development and optimization

• Support new equipment commissioning/qualifications activities

• Assist with developing spare parts for bioprocess equipment

Qualifications

Education:

• Bachelor’s degree in engineering, science, automation, or a related field; required

Experience and Skills:

Required:

• A minimum 6 years of related work experience

• Strong knowledge of maintenance activities in GMP manufacturing, utilities and facilities equipment.

• Strong knowledge of Root Cause Problem Solving, Statistical Analysis and Process Control, Precision Maintenance, Predictive Maintenance.

• Detail and goal oriented, teamwork, customer-focus, thorough understanding of GMPs and regulatory requirements.

• Excellent verbal and written communication skills, including ability to effectively communicate with internal and external customers.

• Influencing skills, partnering and collaboration skills, analytical skills, conflict and risk management skills, critical thinking and good oral and written presentation skills are required.

• Knowledge of cGMP’s for Maintenance in an FDA regulated environment

Preferred:

• People management experience.

• Project Management experience.

• FPX or PMP certification and/or Six Sigma and/or Lean experience.

• Experience in green or brown field GMP MFG facility start-up including process systems, automation, utilities, facilities, and operations.

• Experience in two or more of the following areas: utilities, HVAC, facilities, electrical, metrology, automation, mechanical maintenance.

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 and 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, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.

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