Process Improvement Specialist (Aseptic Fill Finish)

Job Title: Process Improvement Specialist (Aseptic Fill Finish)

Work Location: Kenosha County, Wisconsin

Summary:

Seeking a Process Improvement Specialist to support aseptic pre-filled syringe filling operations by driving operational excellence through data analysis, root cause investigation, and implementation of corrective actions. This role operates on a rotating shift schedule within a 24/7 environment and requires strong independent judgment and collaboration with cross-functional teams.

Responsibilities:

• Gather and document production and downtime metrics using digital tools prior to full system deployment.
• Identify and record inefficiencies related to equipment, workflow, and personnel within the fill/finish process.
• Perform root cause analyses on recurring downtime and quality deviations to determine underlying issues.
• Develop, recommend, and execute corrective actions to address identified process gaps and inefficiencies.
• Work closely with operations, maintenance, and quality teams to ensure alignment and escalate issues as needed.
• Support the commissioning of new production lines and contribute to technology transfer initiatives.
• Utilize analytical skills to interpret production data and drive continuous improvement initiatives.
• Operate independently on rotating shifts, maintaining high standards of safety and compliance in a regulated environment.

Qualifications:

• Bachelor’s degree in Engineering, Life Sciences, or a related STEM field.
• 1–5 years of experience in a manufacturing or operations setting.
• Background in FDA-regulated, CGMP-compliant facilities.
• Strong analytical abilities and experience working with production and downtime data.
• Demonstrated proficiency in root cause analysis methods (such as 5-Why, fishbone, or fault tree analysis).
• Ability to work independently and effectively on rotating shifts.
• Experience in aseptic fill/finish or parenteral drug manufacturing is a plus.
• Familiarity with automated filling or inspection equipment, TPM, Lean, or Six Sigma methodologies, and experience with line commissioning or technology transfer activities are preferred.

Published Category: Manufacturing & Technical Operations