Mes Validations and Sdlc Specialist

hace 2 semanas


Juárez, Chihuahua, México Johnson & Johnson A tiempo completo
At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities, and forward progress.

That's why for more than 135 years, we have aimed to keep people well at every age and every stage of life.

Today, as the world's largest and most broadly based healthcare company, we are committed to using our reach and size for good.

We strive to improve access and affordability, create healthier communities, and put a healthy mind, body, and environment within reach of everyone, everywhere.

Every day, our more than 140,000 employees across the world are blending heart, science, and ingenuity to profoundly change the trajectory of health for humanity.


Diversity, Equity & 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 Move Could Mean Our Next Breakthrough.

We are searching for the best talent for MES VALIDATIONS AND SDLC SPECIALIST (TEMPORARY 8 MONTHS) to be in Ciudad Juarez, Mx.

Job Summary:

You will be responsible for:

Under limited supervision and in accordance with federal, state, and local laws/regulations and Johnson & Johnson Corporate Procedures and Guidelines, this position:

  • Performs advanced tasks consisting primarily of responsibilities to support industrial engineers and
production associates quickly and efficiently.

  • Build products and subassemblies for testing, prototyping, and product or process improvements.
  • Performs periodic preventive maintenance and calibration of the MES equipment. He works
independently on complex projects to frame and solve basic engineering problems.

  • Identifies problem requirements, breaks down problems into manageable, discrete components, and
solves moderate-scoped problems using existing known factors for resolution.

  • Creates and maintains engineering documentation, such as document change orders, validations,
equipment maintenance, manufacturing process instructions, and calibration/preventive maintenance
procedures.

  • Performs basic process validations and process improvements, solves problems, and makes
recommendations to improve processes.

  • Consult with engineering and other personnel on manufacturing capabilities, production schedules, and
other considerations to facilitate production processes.

  • Assists in the engineering of complex tools to aid in the manufacture of the device and assists in
engineering processes to increase efficiency and yields in manufacturing.

  • Is responsible for communicating businessrelated matters or opportunities to the next managerial level
  • For those who supervise or manage personnel, they are responsible for ensuring that subordinates follow
all of the Company's guidelines related to Health, Safety and Environment practices and that all
necessary resources to do so are available and in good condition, if applicable.

  • Is responsible for ensuring personal and Company compliance with all Federal, State and Local company regulations, policies, and procedures
  • Performs other assigned tasks as needed.

Qualifications:

Qualifications and requirements:

  • Bilingual: English/Spanish
  • Bachelor's degree in a related field.
  • Usually, 6 to 8 years of work experience are required
  • Knowledge in Lean tools, 6 Sigma
  • Extensive knowledge of software validation methodologies, SDLC, CSV, GxP.
  • Extensive knowledge of the capabilities and limitations of existing systems.
  • Constant and continuous learning of the relevant technologies necessary to carry out their work.
  • Expert in describing the flow of processes to assist in redesign, reengineering, etc.
  • Understanding of the products and services of the business to be able to define the requirements and
needs of the business partners.

  • Technical collaboration during the design, development, and implementation of Strategic Business
Systems, such as MES.

  • Extensive knowledge of business regulations.
  • Independently, it solves problems within its area of expertise and/or scales problems to the right staff.
to make recommendations for problem solving.

  • Applies compliance requirements within its area of responsibility, provides and performs the required
documentation, and participates in compliance activities as required.

  • Understands the lifecycle management of J&J technology.
emerging concepts.

  • Broad understanding of company processes, strategies, and industry trends.
procedures that support them.

  • Intermediate understanding of Johnson & Johnson's IT standards and strategies.

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