Associate Director, Packaging Equipment Technology Engineering

Responsibilities

• Lead or support complex technical projects and/or equipment technology assessments in packaging and Medical Devices & Combination Products (MDCP) for new product introduction, product/source changes, and device component source changes.
• Lead or support global and site-centric capital/equipment projects (new packaging equipment purchases, transfer/relocation, device component source change assessments, and packaging site operational/launch support).
• Serve as above-site packaging/assembly equipment SME; provide troubleshooting and end-to-end line performance/technology analysis.
• Apply packaging scientific/technical concepts and techniques (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 aligned to Same-Same component/equipment/process principles across platforms.
• Evaluate new technologies for compatibility with existing packaging lines and collaborate with site technology groups.

• Bachelor’s degree 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).
• Track record developing/implementing equipment standards across manufacturing/packaging sites.
• Strong background in medical device, combination product, pharmaceutical packaging equipment, and operational processes.
• Broad experience from design control through product/technology transfer for new and existing packaging facilities.
• Exceptional project management.
• Proven expertise in GMP/quality systems (qualification/validation, root cause analysis, change control, deviation management, cleaning qualification).
• Quantitative decision tools for root cause analysis, risk management, and options analysis.
• Knowledge of cGMP, FDA, EMA, and other regulatory requirements.
• Strong analytical and communication skills.

• Advanced knowledge of packaging and device assembly equipment/processes.
• Experience operating autonomously; strong coordination/communication/supervision.
• Proven ability to resolve technical issues quickly in a fast-paced environment compliantly while meeting customer needs.