Process Engineer: Isolator Technical Specialist

4 days ago


Columbia, South Carolina, United States CLA (CliftonLarsonAllen) Full time
Job Title: Process Engineer: Isolator Technical Specialist

Company Overview:

CliftonLarsonAllen (CLA) Search has been retained by Optima Machinery Corporation to identify a Process Engineer: Isolator Technical Specialist to join their team. With a global presence, Optima Machinery Corporation designs and manufactures packaging and filling machines for pharmaceutical, consumer, nonwovens, and life science products.

Job Summary:

This role involves developing and executing isolator cycle development, qualification, and re-qualification testing using OPTIMA H2O2 decontamination products. The successful candidate will serve as a technical resource for OPTIMA, providing microbiology-related support, including client technical support, process innovation, test method development, training, and industry presentations and publications.

Key Responsibilities:

  • Develop and execute isolator cycle development, qualification, and re-qualification testing
  • Provide technical support for microbiology-related tasks, including client support, process innovation, and test method development
  • Collaborate with the team to develop and implement effective isolator cycle development and validation processes
  • Conduct training and industry presentations to promote OPTIMA's products and services
  • Stay up-to-date with industry developments and regulatory requirements related to aseptic production and sterility testing

Requirements:

  • Bachelor's degree in Engineering, Life Sciences, or a related field
  • Relevant process engineer experience or experience in plant qualification/validation in special machine construction or the GMP area
  • Management experience preferred
  • Knowledge and technical expertise related to H2O2 decontamination, QC Microbiology Lab operations, cGMP Standards, OSHA requirements, FDA and EU guidance related to aseptic production, USP and EP standards related to biological indicators, and sterility testing
  • Effective communication and interpersonal skills
  • Ability to manage multiple projects and meet deadlines

Work Environment:

This is a fully remote position, and the successful candidate will be required to travel to Optima Machinery Corporation locations in Raleigh, NC, Green Bay, WI, and Germany. The travel requirement is estimated at 50% - 70% during weekdays and may include some initial weekend travel for training.



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