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Maintenance Engineer overview

MAM (MAKE Asset Management) is the organization where Innovation and Execution come together. The Maintenance Engineer is responsible for providing engineering and technical support for complex production and processing equipment. Ensures alignment with technology standards and engineering specifications for manufacturing technology. The Maintenance Engineer identifies and leads process improvement projects related to compliance (Quality & EHS), productivity, yield, equipment performance, and cost. Provides technical support, lead investigations, root cause analysis and identify corrective/preventive measures. Review equipment performance trending and identify actions to assure equipment optimum performance/reliability.

Key responsibilities:

• Provides moderately complex design reviews and feedback for improvements in manufacturability.

• Develops process specifications and designs.

• Facilitates and drives experiments, capability studies, and process validation.

• Evaluates and advises on the selection of suitable equipment for optimum process performance.

• Edits and publishes process documentation and training materials for processes, materials, and equipment

• Provide technical support for process, mechanical and automation validations.

• Lead process improvement projects related to quality, compliance, efficiency, yield, and cost.

• Lead capital projects and process improvement teams to meet site needs. Partner with manufacturing to implement process improvements. Assure regulatory compliance and technical feasibility of proposed changes.

• Develop business cases for projects, present to site leadership for approval, and ensure project objectives are met. Optimally manage project resources to ensure budget and schedule compliance.

• Provide technical support, lead investigations and root cause analysis that affect the site.

• Recommend corrective/preventative measures aimed at improving compliance and reducing repeat occurrences. Follow up to resolve if corrective actions adequately address root cause of the deviation or event.

• Partner with Quality Assurance, Manufacturing, Large Molecule Network as needed to assess and document product quality impact.

• Review trending reports and recommend corrective actions for any trends identified.

• Assist with the coordination of data collection and trend analysis as requested by QA and Regulatory Affairs including the annual report required for maintenance of the Statistical Quality Control Database (SQC) and the Annual Product Review (APR).

• Lead engineering execution of projects and initiatives in the platform, for strategic projects and across sites.

• Project Management for strategic and cross sites projects

• Technical support to the maintenance team.

• Ensure projects compliance with EHS&S policies and procedures.

• Support product Technology Transfer projects and investigations in support of marketed products pre and post launch (Technical Life Cycle Management);

• Scout of the market for technologies & innovative approaches and implementations leading.

• Identify and lead energy saving and process improvement initiatives or projects and convey efforts into CIPs.

Qualifications

Education:

A minimum of Bachelor's degree in Engineering is required.

Experience and Skills:

Required:

• A minimum of two (2) years of applicable experience in a GMP manufacturing environment, process engineering, process validation, capital projects or compliance is required

• Experience working with multi-functional project and support teams, serving different employee populations

• Strong Project Management skills

• Systems Qualification and/or Process Validation Experience

• Experience in Operational Excellence, Lean, Process and Design Excellence

• Exposure to Quality Assurance and Regulatory Compliance cGMP and EH&S

• Proficiency in English (written and verbal)

• Skills on reliability engineering

• Ability to effectively present information and respond to questions from groups of managers, customers, and other employees of the organization

Preferred:

• Professional License or certifications according to education background are desirable but not required

• Statistical Skills will be considered as an asset

• Black Belt, Green Belt or Yellow Belt Certification in Six sigma or Lean Manufacturing is desirable

• Risk Assessment/Management and Failure Mode and Effect Analysis training is preferred

• Project Management Training

• Packaging Operations experience is a plus

Other:

• Requires up to 10% domestic and/or international travel

• Requires ability to work standard business hours, with flexibility to support other shifts as needed

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.