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/SolidWorks, 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.
Qualifications (Required):
- 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.
Preferred:
- 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.