Associate Director, Packaging Equipment Technology Engineering

Responsibilities Lead/support complex technical projects and equipment technology assessments in packaging and Medical Devices & Combination Products (MDCP) for new product introduction and product/device component source changes. Lead/support global and site-centric capital/equipment projects: new packaging equipment purchases, equipment transfer/relocation, device component source change assessments, and packaging site operational/launch support. Serve as the above-site packaging and assembly equipment SME for troubleshooting and equipment/end-to-end line performance & technology analysis. Apply packaging technical/scientific concepts (mechanical/electrical knowledge, automation, AutoCAD/SolidWorks, equipment validation/qualification, Lean/Six Sigma, GMP, safety standards, project management, preventive/predictive maintenance, serialization, VOC, process capability, root cause analysis) to resolve technical issues. Partner with Serialization CoE to implement, monitor, and troubleshoot serialization strategy. Establish/maintain packaging equipment specification standards across multiple platforms. Evaluate new technologies for compatibility with existing packaging lines and align with site technology groups. Qualifications Required Bachelor's in Packaging Science/Engineering, Mechanical Engineering, or related discipline. 10+ years in pharmaceutical/biotech/medical device industry; 3+ years in a leadership role (maintenance, operations, and/or engineering). Experience developing/implementing equipment standards across multiple manufacturing/packaging sites. Strong background in medical device/combination product/pharmaceutical packaging equipment and operations. Experience from design control through product and technology transfer for new and existing facilities. Exceptional project management skills. Strong GMP/quality systems expertise: equipment/process qualification & validation, RCA, change control, deviation management, cleaning qualification. Quantitative tools for RCA, risk management, and options analysis. Knowledge of cGMP, FDA, EMA, and international regulatory requirements. Strong analytical and communication skills. Preferred Advanced practical knowledge of packaging and device assembly equipment/processes. Autonomous operation with strong coordination/communication/supervision. Proven track record in fast-paced, compliant technical issue resolution. #J-18808-Ljbffr Scorpion Therapeutics