Company/Role Overview:
CliftonLarsonAllen (CLA) Search has been retained by Optima Machinery Corporation for their Pharma Division to identify Process Engineer: Isolator Technical Specialists to serve their team. With locations and customers all over the world, Optima Machinery Corporation designs and builds packaging and filling machines including complete production lines for pharmaceutical, consumer, nonwovens and life science products.
This individual will develop and execute isolator cycle development, qualification, and re-qualification testing utilizing OPTIMA H2O2 decontamination products. The employee will be a technical resource for OPTIMA for microbiology-related tasks, including client technical support, technical process innovation, test method development, training, and industry presentations and publications.
This job is fully remote and can be based anywhere in the U.S. Travel to Optima Machinery Corporation locations in Raleigh, NC, Green Bay, WI, and Germany will be required. The travel requirement is estimated at 50% - 70% during weekdays and may include some initial weekend travel when training.
To learn more, click here: https://www.optima-packaging.com/en.
What You’ll Do:
- Execute isolator cycle development, qualification, and re-qualification
- Ability to follow SOPs follow instructions, with attention to detail and final report generation.
- Have good written and verbal communication skills.
- Have a strong customer focus.
- Carry out the work in an accurate, independent manner.
- Duties, responsibilities, and activities may change at any time, with or without notice.
What You’ll Need:
- 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 are all desirable.
- Effective communication and interpersonal skills.
- Ability to manage multiple projects and meet deadlines.
