Associate Director, Packaging Equipment Technology Engineering

Responsibilities Lead/support complex technical projects and equipment technology assessments in packaging and MDCP for new product introduction, product/source changes. Lead/support global and site-centric capital/equipment projects: new packaging equipment, transfers/relocations, device component source-change assessments, and site operational/launch support. Serve as above-site packaging/assembly equipment SME; provide troubleshooting and end-to-end line performance/technology analysis. Apply packaging science/engineering concepts to resolve technical issues (mechanical/electrical, automation, AutoCAD/SolidWorks, validation/qualification, Lean/Six Sigma, GMP, safety standards, project management, preventive/predictive maintenance, serialization, VOC, process capability, root cause analysis). Partner with Serialization CoE to implement/monitor/troubleshoot serialization strategy. Establish/maintain packaging equipment specification standards across platforms. Evaluate new technologies for compatibility with existing lines; collaborate with site technology groups. Qualifications (Required) BS in Packaging Science/Engineering, Mechanical Engineering, or related discipline. 10+ years in pharma/biotech/medical device; 3+ years in leadership (maintenance, operations, and/or engineering). Proven success developing equipment standards across multiple sites; strong medical device/combination product/pharma packaging equipment and operations background. Experience from design control through product/technology transfer for new and existing packaging facilities. Strong project management; GMP/quality systems expertise (qualification/validation, root cause analysis, change control, deviation management, cleaning qualification). Quantitative tools for RCA, risk management, options analysis; cGMP/FDA/EMA and international regulatory knowledge. Strong written/oral communication. Preferred Advanced practical knowledge of packaging/device assembly equipment and processes. Autonomous operation with coordination/communication/supervision. Track record resolving issues in fast-paced environments compliantly. Skills/Keywords Biopharmaceutical/biotech; equipment engineering; GMP compliance; Lean/Six Sigma; engineering standards; change/deviation management; packaging engineering/equipment/processes. Benefits Annual bonus and long-term incentive (if applicable); medical/dental/vision, retirement (401(k)), paid holidays/vacation, compassionate and sick days. #J-18808-Ljbffr Scorpion Therapeutics