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/Solid Works, 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.

• 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.

• 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.

Biopharmaceutical/biotech; equipment engineering; GMP compliance;
Lean/Six Sigma; engineering standards; change/deviation management; packaging engineering/equipment/processes.

• Annual bonus and long-term incentive (if applicable); medical/dental/vision, retirement (401(k)), paid holidays/vacation, compassionate and sick days.