25 Jun, 2021

Process Engineer

  • Johnson & Johnson
  • Irving, TX, USA
Process Engineer Biochemicals / Pharmaceuticals Chemicals

Job Description

Mentor part of Johnson & Johnson Family of Companies is recruiting for a Process Engineer II located in Irving, TX.

Mentor is a leading supplier of breast implants in the global aesthetic market. The company develops, manufactures, and markets innovative, science-based products for surgical and non-surgical medical procedures that allow breast surgery patients to improve their quality of life. The company is focused on two strategic areas: breast reconstruction and breast augmentation.  MENTOR® is the only manufacturer whose silicone breast implants are made in the U.S.A. For over 20 years, more than 5 million women have chosen MENTOR® Breast Implants.

  • Responsible to identify process improvement initiatives and develops proposals for problem solving improvement or optimization
  • Support process improvement projects that have the objectives of developing more cost efficient and quality enhanced processes.
  • Establish machine and process standards and overall equipment efficiency
  • Assist in the development of more effective operational control systems.
  • Evaluate data generated through studies using statistical analytical methods.
  • Responsible for the development and/or revision of production standards and standard work documents.
  • Develops, writes and executes engineering studies, design of experiments, and IQ/OQ/PQ protocols and reports.

 

DUTIES & RESPONSIBILITIES*

Under general direction and in accordance with all applicable federal, state and local laws/regulations and

Corporate Johnson & Johnson, procedures and guidelines, this position:

  • Works on optimization of process output and throughput, equipment utilization, equipment downtime, waste reduction/yield improvements, budget management, standard cost and capital investment management.
  • Provides technical support to the production areas evaluating process deficiencies, process changes, modifications and equipment failure. Defines, analyzes, reviews and evaluates problems for prompt solutions.
  • Determines, adapts, and modifies methods and standards to control all aspects of assigned projects or portions of major projects.
  • Coordinates phases of work with other departments within the company and with other Medical Device divisions.
  • Perform Investigation and writes NC reports following established timelines.
  • Routes and follows up on NC reports through the evaluation, review and approval processes to comply with the established timeline.
  • Coordinates and participates in Cross Functional Investigations (CFI)
  • Revise and maintain engineering and equipment procedures.
  • Follows Standard Operating Procedures (SOP), Good Manufacturing Practices (GMPs), Company Policies and Federal, State and Local Government Regulations.
  • Map processes and analyze current status and potential future states with improvements. Define and quantify improvements to further analyze the gains. Use tools from Lean and Six Sigma to create and execute CIP projects.
  • Participates in GMP audits regarding equipment recording and machine performance.
  • Coordinates communications and interfaces with end users, machine manufacturers and/or suppliers.
  • Participates in projects involving other departments and activities (CIM, QIP, CFM, etc.).
  • Writes, develops and implements validation procedure
  • Comply J&J Safety Requirements and ensure safe working conditions and practices in the department.
  • Reviews and analyzes data, understanding of statistics and the application of statistical data, able to determine normal and non-normal data along with probable causes of non-normal results.
  • Demonstrate independent understanding and application of core GMP fundamentals, including but not limited to: Data Integrity (DI), Good Manufacturing Practices (GMP), and Good Documentation Practices (GDPs).
  • Responsible for communicating business related issues or opportunities to next management level
  • Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
  • Performs other duties assigned as needed


Qualifications

  • Bachelor’s degree in engineering discipline
  • 2-4 years’ experience in engineering in a medical device environment preferred.
  • Advanced computer skills and use of software applications. Strong computer background (MS Office, MS Project Management, PowerPoint, Word, Excel, Outlook etc.)
  • Experience in a manufacturing environment developing manufacturing standards.
  • Proven ability to anticipate and solve problems.
  • Ability to prioritize multiple commitments and technical problem-solving duties.
  • Experience or knowledge in short and long-term project management.
  • Provides technical support to the production areas evaluating process deficiencies, process changes, modifications and equipment failure. Defines, analyzes, reviews and evaluates problems for prompt solutions.

 

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


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