Engineer III, Manufacturing Sciences

Role: Manufacturing Sciences Engineer III, specializing in single-use consumable raw materials for biopharmaceutical manufacturing, supporting process optimization and regulatory compliance. Responsibilities: serve as technical point of contact for raw materials, oversee supplier capabilities, control strategies, and material qualification; lead investigations and troubleshoot material failures; support extractables/leachables studies and regulations; and participate in industry forums and audits. Requirements: Bachelor’s degree in a scientific or technical field; minimum 2 years of relevant industry experience; knowledge of polymer chemistry, single-use systems, and regulatory documentation support; willingness to work on-site during critical activities. Preferred: engineering or chemistry degrees; hands-on experience with extractables/leachables and supplier change management; prior manufacturing or engineering experience supporting deviations, CAPAs, and regulatory filings; experience collaborating with vendors and external partners. HighValue: biopharma manufacturing, single-use technologies, extractables/leachables, support for GMP operations, global regulatory compliance, and vendor audits. WorkSetup: hybrid with on-site presence during inspections and audits.