Associate Director, Packaging Equipment Technology Engineering

Scorpion Therapeutics; Durham (NC); On-site; USD 150,000 - 190,000; Full time

Job summary

Scorpion Therapeutics in Durham, NC seeks a senior Packaging Engineering leader to guide complex projects across pharmaceutical packaging and MDCP, from design control to tech transfer and site launches.

Requires 10+ years in pharma/biotech, a BS in Packaging/Engineering, and strong GMP, project management, and cross-site standards experience. Lead equipment standards and serialization initiatives with global teams.

Qualifications

• Bachelor's degree in Packaging Science/Engineering or related field.
• 10+ years in pharma/biotech/medical device industry with leadership exp.
• Experience developing/implementing equipment standards across multiple sites.
• Strong background in packaging equipment, operations, and tech transfer.
• Experience from design control through product and technology transfer.

Responsibilities

• Lead/support complex technical packaging and MDCP projects for new product introductions and source changes.
• Lead/support global capital/equipment projects including new packaging equipment purchases and relocations.
• Serve as packaging equipment SME for troubleshooting and performance analysis.
• Apply packaging concepts (mechanical/electrical, automation, qualification) to resolve issues.
• Partner with Serialization CoE to implement serialization strategy.
• Establish/maintain packaging equipment specification standards across platforms.
• Evaluate new technologies for compatibility with packaging lines.

Skills

Project management

Root cause analysis

GMP

Change control

Validation

Process qualification

Communication

AutoCAD

SolidWorks

Education

Bachelor's in Packaging Science/Engineering

Tools

AutoCAD

SolidWorks

Job description

Responsibilities

• Lead/support complex technical projects and equipment technology assessments in packaging and Medical Devices & Combination Products (MDCP) for new product introduction and product/device component source changes.
• Lead/support global and site-centric capital/equipment projects: new packaging equipment purchases, equipment transfer/relocation, device component source change assessments, and packaging site operational/launch support.
• Serve as the above-site packaging and assembly equipment SME for troubleshooting and equipment/end-to-end line performance & technology analysis.
• Apply packaging technical/scientific concepts (mechanical/electrical knowledge, automation, AutoCAD/SolidWorks, equipment 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.
• Establish/maintain packaging equipment specification standards across multiple platforms.
• Evaluate new technologies for compatibility with existing packaging lines and align with site technology groups.

Qualifications

Required

• Bachelor's in Packaging Science/Engineering, Mechanical Engineering, or related discipline.
• 10+ years in pharmaceutical/biotech/medical device industry; 3+ years in a leadership role (maintenance, operations, and/or engineering).
• Experience developing/implementing equipment standards across multiple manufacturing/packaging sites.
• Strong background in medical device/combination product/pharmaceutical packaging equipment and operations.
• Experience from design control through product and technology transfer for new and existing facilities.
• Exceptional project management skills.
• Strong GMP/quality systems expertise: equipment/process qualification & validation, RCA, change control, deviation management, cleaning qualification.
• Quantitative tools for RCA, risk management, and options analysis.
• Knowledge of cGMP, FDA, EMA, and international regulatory requirements.
• Strong analytical and communication skills.

Preferred

• Advanced practical knowledge of packaging and device assembly equipment/processes.
• Autonomous operation with strong coordination/communication/supervision.
• Proven track record in fast-paced, compliant technical issue resolution.