Responsibilities:
- Lead/support complex technical projects and equipment technology assessments in packaging and Medical Devices & Combination Products (MDCP) for new product introductions and source/device component changes.
- Lead/support global and site-centric capital/equipment projects (new packaging equipment, transfers/relocations, device component source change assessments, site operational/launch support).
- Serve as on-site packaging/assembly SME for troubleshooting and equipment/end-to-end line performance & technology analysis.
- Apply packaging technical concepts (mechanical/electrical, automation; AutoCAD/SolidWorks; equipment validation/qualification; Lean/Six Sigma; GMP; safety; project management; preventive/predictive maintenance; serialization; VOC; process capability; root cause analysis) to resolve issues.
- 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 and align with site technology groups.
Qualifications:
Required:
- BS in Packaging Science/Engineering, Mechanical Engineering, or related discipline.
- 10+ years pharma/biotech/medical device; 3+ years in a leadership role (Maintenance/Operations/Engineering).
- Success implementing equipment standards across multiple sites.
- Strong medical device/combination product/pharma packaging equipment and operational process background; design control through tech transfer.
- Exceptional project management.
- GMP/quality systems expertise: qualification/validation, root cause analysis, change control, deviation management, cleaning qualification.
- Quantitative risk/options/root-cause tools; knowledge of cGMP/FDA/EMA/international regs.
- Strong analytical, decision-making, and written/oral communication.
Preferred:
- Practical packaging/device assembly equipment/process expertise; autonomous operation; fast-paced compliant issue resolution.