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/Solid Works, 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.

• 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.

• 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.