Manufacturing Controls Engineer II

3 weeks ago

Westbrook, United States TalentBurst, an Inc 5000 company Full time
  • The position of Manufacturing Controls Engineer II is within our Infectious Disease Developed Markets business located in Maine.
  • This role will be responsible for supporting for supporting product development from concept through sustained manufacturing of FDA regulated products. Completion of process development, equipment acquisition and leadership of supporting development partners. Experience with manufacturing processes, quality/cost savings initiatives and implementation of engineering principles while assuring compliance with cGMP, quality and safety standards.
  • This job description will be reviewed periodically and is subject to change by management.


Responsibilities:

  • Process development, equipment specification, acquisition, and implementation.
  • Evaluation of machine logic and controls to troubleshoot equipment and identify process improvement opportunities.
  • Integration of controls hardware and software into new and existing manufacturing equipment.
  • Design of experiments, validation, completion of testing and analysis of data.
  • Creates and revises manufacturing documents, specifications, standard operating procedures (SOPs), safety instructions, validation protocols, risk assessments, and procedures and other technical documents to ensure compliant, efficient and safe procedures.
  • Works with other engineers and technicians in developing solutions and improvements in materials, equipment, and process as necessary.
  • Actively participates in teams as necessary to ensure continual improvement, safety, and compliance.
  • Lead cross functional project teams and coordinate activities.
  • Must be able to work on problems of diverse scope where analysis of the problem requires evaluation of obscure or unknown data.
  • Familiarity with cGMP and ISO 13485 regulations and practices is desired.


Basic qualifications | education:

  • Bachelor's degree (BS) in engineering or equivalent combination of education and experience.
  • Minimum 3 years engineering experience in a manufacturing environment.
  • Experience working in a GMP, FDA, ISO and USDA regulated environment preferred.
  • Previous experience with common manufacturing automation technologies and architectures is required.
  • Programmable Logic Controllers (PLC's) (Allen Bradley Logix5000 experience preferred)
  • Ability to read and troubleshoot existing ladder logic.
  • Ability to generate new ladder logic for the sequencing of complex manufacturing tasks.
  • Human Machine Interfaces (HMI) (Allen-Bradley Factory Talk View experience preferred)
  • Ability to modify and troubleshoot existing user interfaces.
  • Ability to design and implement new user interface functionality.
  • Motion Control to include Servo Drives, VFD's and Stepper Drives.
  • Robots (Staubli and/or Epson experience preferred)
  • Ability to modify robot programs and taught positions.
  • Ability to sequence new robot paths and functions.
  • Ability to troubleshoot existing vision inspection applications.
  • Ability to design new systems to include lens and lighting selection.
  • Ability to read and trace machine control systems from electrical prints
  • Ability to troubleshoot common machine control hardware (relays, fuses, breakers, etc.)


Preferred qualifications:

  • Experience working in a GMP, FDA, ISO and USDA regulated environment.
  • Familiarity with cGMP and ISO 13485 regulations and practices.
  • Familiarity with statistical analysis software (Minitab).

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