Associate Director, Engineering - Packaging Technology
Scorpion Therapeutics, Phila, Pennsylvania, United States
Role Summary
The Associate Director, Engineering - Packaging Technology will provide technical leadership and support to the internal and external packaging network, developing and executing packaging and device assembly equipment and processes, including packaging equipment design and development, ensuring packaging process control and efficiency, and delivering ongoing packaging and device technical support across the lifecycle. The role requires deep process and equipment expertise in packaging and/or assembly, a strong track record in problem-solving, strategic acumen, and the ability to lead cross-functional projects.
Responsibilities
Lead or support complex technical projects and/or equipment technology assessments within the packaging and Medical Devices & Combination Products (MDCP) space as part of new product introduction, product source change and/or device component source changes.
Lead or support complex global and site-centric capital and equipment projects, including new packaging equipment purchases, packaging equipment transfer/relocation, device component source change assessment, and packaging site operational and launch support. Travel approximately 30% on average with occasional peaks during critical milestones.
Serve as the above-site packaging and assembly equipment SME, providing direct technical support to the packaging network in areas of troubleshooting of the packaging operation, equipment and End-to-End line performance and technology analysis (continuous improvement, root cause analysis, equipment technology and capability assessments).
Apply packaging scientific/technical concepts and techniques (e.g., mechanical and electrical knowledge, automation expertise, AutoCAD/SolidWorks competency, equipment validation and qualification, Lean Manufacturing/Six Sigma, GMP, Safety Standards, Project management, Preventive and Predictive maintenance, Serialization, VOC, process capability, root cause analysis) to resolve scientific/technical packaging issues.
Collaborate with our Serialization CoE on serialization strategy and serve as the SME to work with internal packaging sites in North America for implementation, monitoring, and troubleshooting support.
Establish and maintain specific packaging equipment specification standards across multiple packaging platforms (e.g., Bottle, Blister, Vial, Pre-filled syringe, Autoinjector) in line with standard component/equipment/process principles; evaluate new technologies for compatibility with existing packaging lines and coordinate with site technology groups to ensure alignment.
Education
A bachelor’s degree in Packaging Science/Engineering, Mechanical Engineering, or a related technical discipline (such as Chemical Engineering or Material Engineering) is mandatory.
Qualifications
Minimum of 10 years’ experience in the pharmaceutical, biotechnology, or medical device industry, with at least 3–5 years in a leadership role (i.e., Maintenance, Operation and/or Engineering).
Demonstrated success in developing and implementing equipment standards across multiple manufacturing or packaging sites along with extensive practical knowledge in supporting packaging equipment design, development and qualification.
Strong background in the medical device, combination product, pharmaceutical packaging equipment and operational process and related scientific/technical concepts and techniques.
Broad experience with devices and combination products, covering design control to product and technology transfer for both new and existing packaging facilities.
Exceptional project management skills, from conception and initiation, through project close-out.
Thorough knowledge and proven expertise in GMP application and quality systems, particularly in process and equipment qualification & validation, root cause analysis, change control, deviation management, and cleaning qualification.
Expert grasp of relevant scientific or technical concepts (e.g., mechanical & electrical knowledge, automation expertise, AutoCAD/SolidWorks competency, equipment validation & qualification, Lean Manufacturing/Six Sigma, GMP, Safety Standards, Project mgmt., Preventive & Predictive maintenance, Serialization, VOC, process capability, root cause analysis) to handle routine and complex tasks, along with advanced practical knowledge of techniques applicable to these tasks.
Extensive experience with quantitative decision tools for root cause analysis, risk management and options analysis.
Exhibited leadership qualities such as working collaboratively, managing change, accountability, adaptability and other attributes in a diverse, cross-functional team.
Proven track record in operating in a fast-paced operating environment to resolve technical issues while meeting customer needs in a compliant manner.
Demonstrated capability in operating autonomously to offer strong coordination, communication, and supervision on all technical issues.
Strong knowledge of cGMP, FDA, EMA, and other international regulatory requirements.
Strong analytical and decision-making abilities, combined with outstanding oral and written communication skills.
Skills
Biopharmaceutical Industry
Change Management
Combination Products
Cross-Functional Teamwork
Detail-Oriented
Deviation Management
Engineering Standards
GMP Compliance
Good Manufacturing Practices (GMP)
Lean Manufacturing
Management Process
Mechanical Engineering
Medical Devices
Packaging Engineering
Packaging Equipment
Packaging Optimization
Packaging Processes
Pharmaceutical Packaging
Process Optimization
Regulatory Requirements
Risk Management
Root Cause Analysis (RCA)
Technical Issues
Technical Leadership
Technical Projects
Additional Requirements
Travel: approximately 30% on average with occasional peaks during critical milestones.
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Responsibilities
Lead or support complex technical projects and/or equipment technology assessments within the packaging and Medical Devices & Combination Products (MDCP) space as part of new product introduction, product source change and/or device component source changes.
Lead or support complex global and site-centric capital and equipment projects, including new packaging equipment purchases, packaging equipment transfer/relocation, device component source change assessment, and packaging site operational and launch support. Travel approximately 30% on average with occasional peaks during critical milestones.
Serve as the above-site packaging and assembly equipment SME, providing direct technical support to the packaging network in areas of troubleshooting of the packaging operation, equipment and End-to-End line performance and technology analysis (continuous improvement, root cause analysis, equipment technology and capability assessments).
Apply packaging scientific/technical concepts and techniques (e.g., mechanical and electrical knowledge, automation expertise, AutoCAD/SolidWorks competency, equipment validation and qualification, Lean Manufacturing/Six Sigma, GMP, Safety Standards, Project management, Preventive and Predictive maintenance, Serialization, VOC, process capability, root cause analysis) to resolve scientific/technical packaging issues.
Collaborate with our Serialization CoE on serialization strategy and serve as the SME to work with internal packaging sites in North America for implementation, monitoring, and troubleshooting support.
Establish and maintain specific packaging equipment specification standards across multiple packaging platforms (e.g., Bottle, Blister, Vial, Pre-filled syringe, Autoinjector) in line with standard component/equipment/process principles; evaluate new technologies for compatibility with existing packaging lines and coordinate with site technology groups to ensure alignment.
Education
A bachelor’s degree in Packaging Science/Engineering, Mechanical Engineering, or a related technical discipline (such as Chemical Engineering or Material Engineering) is mandatory.
Qualifications
Minimum of 10 years’ experience in the pharmaceutical, biotechnology, or medical device industry, with at least 3–5 years in a leadership role (i.e., Maintenance, Operation and/or Engineering).
Demonstrated success in developing and implementing equipment standards across multiple manufacturing or packaging sites along with extensive practical knowledge in supporting packaging equipment design, development and qualification.
Strong background in the medical device, combination product, pharmaceutical packaging equipment and operational process and related scientific/technical concepts and techniques.
Broad experience with devices and combination products, covering design control to product and technology transfer for both new and existing packaging facilities.
Exceptional project management skills, from conception and initiation, through project close-out.
Thorough knowledge and proven expertise in GMP application and quality systems, particularly in process and equipment qualification & validation, root cause analysis, change control, deviation management, and cleaning qualification.
Expert grasp of relevant scientific or technical concepts (e.g., mechanical & electrical knowledge, automation expertise, AutoCAD/SolidWorks competency, equipment validation & qualification, Lean Manufacturing/Six Sigma, GMP, Safety Standards, Project mgmt., Preventive & Predictive maintenance, Serialization, VOC, process capability, root cause analysis) to handle routine and complex tasks, along with advanced practical knowledge of techniques applicable to these tasks.
Extensive experience with quantitative decision tools for root cause analysis, risk management and options analysis.
Exhibited leadership qualities such as working collaboratively, managing change, accountability, adaptability and other attributes in a diverse, cross-functional team.
Proven track record in operating in a fast-paced operating environment to resolve technical issues while meeting customer needs in a compliant manner.
Demonstrated capability in operating autonomously to offer strong coordination, communication, and supervision on all technical issues.
Strong knowledge of cGMP, FDA, EMA, and other international regulatory requirements.
Strong analytical and decision-making abilities, combined with outstanding oral and written communication skills.
Skills
Biopharmaceutical Industry
Change Management
Combination Products
Cross-Functional Teamwork
Detail-Oriented
Deviation Management
Engineering Standards
GMP Compliance
Good Manufacturing Practices (GMP)
Lean Manufacturing
Management Process
Mechanical Engineering
Medical Devices
Packaging Engineering
Packaging Equipment
Packaging Optimization
Packaging Processes
Pharmaceutical Packaging
Process Optimization
Regulatory Requirements
Risk Management
Root Cause Analysis (RCA)
Technical Issues
Technical Leadership
Technical Projects
Additional Requirements
Travel: approximately 30% on average with occasional peaks during critical milestones.
#J-18808-Ljbffr