Process Improvement Specialist

Process Improvement Specialist – Aseptic Fill/Finish Operations Role Summary Support a newly commissioned aseptic pre-filled syringe (PFS) filling line through data-driven downtime reduction and operational improvement. Working rotating shifts (days/nights) in a 24/7 coverage model, this candidate will collect and analyze operational data, identify inefficiencies across equipment, people, and process, and drive corrective actions to completion. The role requires strong independent judgment with senior-level engineering support accessible at all times. Key Responsibilities Collect and record production and downtime data in digital systems pending site historian deployment Observe and document operational inefficiencies – equipment, workflow, and human factors Conduct root cause analyses on recurring downtime events and quality escapes Develop and implement corrective actions with a strong bias toward execution Collaborate with site operations, maintenance, and quality teams; elevate to senior engineers as appropriate Qualifications Required Bachelor’s degree in Engineering, Life Sciences, or related STEM discipline 1–5 years of experience in a manufacturing or operations environment Experience in an FDA-regulated, CGMP facility Strong analytical skills – comfortable working with production and downtime data sets Demonstrated RCA capability (5-Why, fishbone, fault tree, or equivalent) Self-directed with the ability to operate independently on rotating shifts Preferred Experience in aseptic fill/finish or parenteral drug manufacturing Familiarity with automated filling or inspection equipment Exposure to TPM, Lean, or Six Sigma methodologies Experience supporting line commissioning or technology transfer activities #J-18808-Ljbffr