Engineer I/II

KBI Biopharma•Boulder, CO

About The Position

This role applies engineering skills to process engineering projects supporting process development, process transfer, and clinical or commercial manufacturing. As an MS&T Engineer, the successful candidate supports cGMP production operations by applying engineering principles to technology transfer, existing manufacturing processes, and process validation. The role offers hands-on development of biologics manufacturing knowledge and expertise, and involves working with cross-functional teams and clients to introduce manufacturing processes at production scale, improve processes, troubleshoot technical issues, and meet client and regulatory standards. The position is suited to an engineer with a chemical or biological engineering background who works collaboratively and contributes to manufacturing science and technology excellence.

Requirements

Engineer I: B.S. in Engineering or a related field.
Engineer II: M.S. in Engineering or a related field, or a B.S. and 3+ years of relevant experience.
Established expertise in biotech unit operations.
Ability to apply engineering skills to solve problems of moderate scope and recognize when additional technical resources are required.
Strong technical writing and communication skills.

Responsibilities

Provide engineering support during process development and technology transfer by evaluating and influencing process implementation strategies.
Monitor process performance in manufacturing and lead process troubleshooting efforts.
Author technical documents, including product impact assessments, product campaign summaries, and/or CPV reports.
Set priorities and lead initiatives and/or projects within the function.
Represent PD in providing technical solutions for specific projects.
Plan and conduct own work, resolving technical problems of moderate scope and complexity with general guidance from a supervisor and seeking technical guidance for unusual or complex problems.