05 Oct, 2021

Senior Process Engineer

  • Johnson & Johnson
  • Juárez, Nuevo Leon, Mexico
Process Engineer Biochemicals / Pharmaceuticals Chemicals

Job Description

At Johnson & Johnson, the largest healthcare company in the world, we come together with one purpose: to profoundly change the trajectory of health for humanity. 

Diversity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than 130 years. Regardless of your race, belief, sexual orientation, religion or any other trait, YOU are welcome in all open positions at the largest healthcare company in the world. 

When You Join Johnson & Johnson, Your Next Move Could Mean Our Next Breakthrough. 

Ethicon, Wound Closure and Repair is a trusted, world-wide leader in medical devices company who commits to the advance surgery and improves lives every single day. We are qualified as one of the top best place to work. Joining Ethicon is more than joining a great company, it means belonging to a legacy of innovation, development and philanthropy. For more information, visit www.ethicon.com

SENIOR PROCESS ENGINEER (1 OF 3)

Completes engineering projects by organizing and controlling project elements and is responsible for all engineering and technical disciplines that projects involve. The project engineer will schedule, plan, forecast, resource and manage all the technical activities aiming at assuring project accuracy and quality from conception to completion.

DUTIES & RESPONSIBILITIES:

Under general supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position responsibilities may include, but are not limited to:

  • Lead engineering projects ensuring that projects are completed on time and within budget with no impact to quality or customer service.
  • Develop project objectives and project plans conferring with management and executes detailed project plans using standard project management tools (charter, Gantt chart, etc).
  • Determines project schedule by studying project plan and specifications, product design, customer requirements and product performance standards; calculating time requirements; sequencing project elements, completing technical studies and preparing cost estimates
  • Controls and maintains project plan and schedule by reviewing design, specifications and monitoring project progress, and project budget.
  • Plans and schedules project changes; coordinating activities; recommending actions and resolving problems.
  • Through project coordination meetings and other forms of communication, oversees and coordinates the technical aspects of the project.
  • Approves and plans expenditures; and keeps an accurate record of all elements of the project
  • Prepares and presents project status reports in formats adequate to different organizational levels by collecting, analyzing, and summarizing information and trends; recommending actions
  • Follows the Ethicon change control process for all applicable projects.
  • Confirms product performance by designing and conducting tests and performs process validation on new, transferred or modified processes
  • Prepares/reviews capital & expense forecasts for assigned projects. Prepares capital authorization requests (CAR).
  • Controls project costs by approving and monitoring expenditures; administering contractor contracts.
  • Maintains project integrity and reputation through compliance with state and federal regulations.
  • Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
  • Ensures effective use of engineering and quality systems and adherence to quality system regulations (QSR). Ensures compliance to the quality policy in all activities.
  • Manages the NCR and CAPA process by documenting, investigating, root cause analysis, and implementing corrective actions for product non-conformances.
  • Maintains safe and clean working environment by enforcing procedures, rules, and regulations.
  • Ensures all OSHA and J &J Machine Guarding requirements are met.
  • Supports and promote the safety and industrial hygiene objective of the plant
  • Responsible for communicating business related issues or opportunities to next management level
  • Other responsibilities may be assigned and not all responsibilities listed may be required.
  • Responsible for communicating business related issues or opportunities to next management level
  • For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
  • Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
  • Performs other duties assigned as needed
  • Perform technical assessments and develop validation strategies and understand the impact on E2E supply chain.
  • Understand the product and process structure (BOMs, Routes, DMR, etc.)
  • Propose project ideas through analysis of existing processes and equipment with the intent of achieving continuous improvement, including the business case assessment.
  • Provide coaching to junior engineers, clerks, technicians

 


Qualifications

EXPERIENCE AND EDUCATION:

  • B.S Engineering Degree or Science Discipline
  • Approximate experience, or equivalent knowledge and skills, necessary to satisfactorily perform the position responsibilities
  • 4 to 6 years experience in manufacturing/design engineering

REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS:

  • Six Sigma Green or Black Certification and/or other project management methodology is preferred
  • Able to read and understand engineering drawings and translate product drawings into process information
  • Hands on experience with manual and automation assembly equipment and/or processes
  • Position requires excellent organizational and communication skills (written and oral, fluent in English) plus the ability to function/lead in a team-based manufacturing environment.
  • Ability to make and manage good relationships
  • Presentation skills
  • Able to make decisions
  • Demonstrates strong negotiating and influencing Skills.
  • Analytical and problem-solving skills
  • Initiative and results/target focused
  • Experience in Bill of Material (BOM) structures
  • An understanding of Lean Manufacturing and lean principles with an ability to promote and drive continuous improvement
  • Understanding of design and production costs to include waste, downtime, scrap and re-work
  • Understanding of calibration concepts and Measurement systems.
  • Understanding of International customs procedures.
  • Experience with the essential requirements of the Medical Device Directive (MDD), ISO 13485, FDA design controls or similar regulatory environment in design control and process validation
  • Experience on medical device (Class II or Class III) projects.
  • Experience utilizing enterprise resource planning (ERP) tools.
  • Experience in project management,
  • Understanding of customer expectations and deliverables with an awareness of the impact of failure/cost of poor quality

Other Additional Requirements:

  • May be required to work off-shift or weekends occasionally during peak project activities.
  • Ability to work in a clean room environment.
  • Occasionally may be required to work with measurement equipment/instruments such as rulers, calipers, multimeters, thermocouples, etc.

RESPONSIBILITY FOR OTHERS & INTERNAL INTERACTIONS:

  • Provides technical guidance to all departments related to product and process knowledge.
  • Interviews and assigns personnel to specific phases and elements of the project.
  • Regularly monitors contractors and project team members. Allocates project resources appropriately.
  • Presents procedures, rules and regulations to those involved in the project.
  • Support cross functional teams during investigations related to mixes, FG failures, and customer complains.
  • For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
  • Experience in building/leading cross-disciplinary project teams.
  • Position reporting to Product and Process Engineering Manager or Systems and Technology Engineering Manager within the Technical Operations department
  • Interacts with all levels and roles of the organization internal and external.
  • May be delegated on some activities such as documents approval or P.O. approvals from Product and Process Engineering Manager, Systems and Technology Engineering Manager, or Project Manager.
  • May be responsible for receiving and greeting visitors and provide presentations or plant tours
  • Works with other department such as human resources, purchasing, payroll, Process Engineering, Business Excellence Engineering, Operations and finance to ensure that a variety of business transactions are completed
  • Participates in Management Reviews as required
  • Host business meetings with other functions
  • Participates in internal audits, may present/explain issues/situations/validations to auditors

LOCATION & TRAVEL REQUIREMENTS:

  • Primary Location is Ethicon Juarez Independencia Plant
  • Percentage of expected travel for either domestic and international is 20%

EXTERNAL INTERACTIONS:

  • Participates in external audits, may present/explain issues/situations/validations to auditors.
  • Direct interaction with other J&J Plants
  • Coordinates phases of work with outside vendors
  • Works with equipment vendors directly to review equipment requirements, quote new or modification to equipment and, processes. Monitors equipment development with vendors.
  • Reviews contractor bids; interviews and assigns contactor personnel to specific phases and elements of the project.
  • Regularly monitors contractors; approves and plans employee contractor contracts

 


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