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/SolidWorks, 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.
Qualifications:
Required:
- Bachelorβs 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.