Manufacturing Control System Engineer II

Andrx Pharmaceuticals   •  

Miramar, FL

11 - 15 years

Posted 268 days ago

This job is no longer available.

Job Summary

This position is responsible for the daily support of existing Manufacturing equipment as well as the design, management, installation, successful validation and support of automation projects located at the Aveva DDS Manufacturing facility.

Job Responsibilities

  • Manage and execute all phases of automation projects: conceptualize, develop, design, procure, install, assemble, program, test, and validate.  Work with outside contractors when required during peak project demand.
  • Familiar with Vision, printing, and product serialization technology and systems.
  • Possess excellent technical writing skills to prepare all required written project documentation for automation projects within a GMP regulated environment including User Specification, Functional Specification, Hardware Design Specification, Software Design Specification, Hardware Test, Software Test, Network Test, Installation Qualification, Operational Qualification, Operating Procedures, Support Documentation, Trouble-shooting Guide, etc.
  • Strong ability to support programming of PLCs, Operator Interfaces, Network Communications, and PC interfaces.
  • Utilize electrical, control (including PLC, VFD, and Servo) mechanical, and process trouble-shooting skills to provide support for production operations in a multi-shift manufacturing environment.
  • Available to Support production equipment on an on-call basis as determined by the resource allocation plan.
  • Demonstrated strong commitment to compliance to provide GMP and Change Control requirements required by the Pharmaceutical industry.
  • Utilize analytical skills, technical background, and innovation to solve a wide variety of automation and production challenges.
  • Maintain the electrical and electronic aspects of operating process equipment as needed, including upgrades of these items.
  • Ability to generate all necessary support documentation and spare parts list associated with a project to allow others to properly support equipment following commissioning.
  • Oversee and verify all operating aspects of new equipment at installation.
  • Demonstrated ability to effectively communicate with teams, colleagues and stake holders.

Job Requirements

Knowledge of:

  • Current Good Manufacturing Practices (cGMPs), Food and Drug Administration (FDA), Pharmaceutical Manufacturing SOPs and other regulatory requirements.
  • Business English usage, spelling, grammar and punctuation.
  • Basic mathematical and statistical computation methods and practices.
  • PLC, Vision system, Human Machine Interface, Serialization equipment, printing equipment setup and troubleshooting.

 

Skill in:

  • Ability to communicate effectively with Production personnel, management and project team members regarding project requirements / status.
  • Ability to determine proper scaling for analogcircuits, and engineering design and calibration. 
  • Ability to convert between base numbers (binary to hex, etc.) as required for PLC programming. 
  • Good analytical skills are required to develop sound engineering solutions to scale-up, manufacturing, and process challenges which consider productivity, robustness, safety, cost effectiveness, and reliability.   This requires an understanding of basic control elements (electronic, mechanical, pneumatic, etc.), system design, and interaction between each of these and the process and human aspects.   The individual should be capable of separating reliability issues from equipment, process, and operating deficiencies, and provide recommendations for improvements in each area when warranted.

 

Minimum Qualifications: 

Bachelors Degree (B.S.) in Electrical Engineering or equivalent from four-year college or university along with a minimum 10 year’s experience or more in a similar capacity in an industrial or design environment. Serialization, Printing, and Vision system Design experience with Pharmaceutical Packaging OEM is a plus.