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 source/device component changes.
• Lead/support global and site-centric capital/equipment projects (new packaging equipment purchases, transfer/relocation, source change assessments, site operational and launch support).
• Serve as above-site packaging/assembly SME for troubleshooting and end-to-end line performance/technology analysis.
• Apply packaging scientific/technical methods (mechanical/electrical knowledge, automation, AutoCAD/Solid Works, 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.
• Define/maintain packaging equipment specification standards using Same-Same principles.
• Evaluate new technologies for compatibility with existing lines; align with site technology groups.

Required:

• Bachelor’s in Packaging Science/Engineering, Mechanical Engineering, or related field.
• 10+ years in pharma/biotech/medical devices; 3+ years in a leadership role (maintenance/operations/engineering).
• Experience developing/implementing equipment standards across multiple sites.
• Strong background in medical device/combination product/pharma packaging equipment and processes.
• Experience from design control through technology transfer.
• Exceptional project management.
• Proven GMP/quality systems expertise (qualification/validation, root cause analysis, change control/deviation management, cleaning qualification).
• Quantitative root cause/risk/options analysis.
• Knowledge of cGMP and FDA/EMA/international regulations.

Preferred:

• Advanced practical knowledge of packaging/device assembly equipment and processes.
• Ability to operate autonomously and supervise/coordinate technical issues.
• Track record resolving issues in fast-paced, compliant environments.

• GMP compliance, change/deviation management, engineering standards, equipment experience, packaging engineering/equipment/process optimization, Lean manufacturing/Lean Six Sigma, cross-functional teamwork.

• Medical, dental, vision, retirement benefits (401(k)), paid holidays, vacation, compassionate and sick days.