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Associate Director, Package Engineer Asia Pacific External Partners
- Our Engineers support internal and external manufacturing operations remain operational, continuously improve and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation.
・This is a packaging generalist position for an advanced practitioner of our Company's Leadership Behaviors and Inclusive Behaviors. The incumbent will be responsible for leading the technical interface with external packaging partners. These partners are Contract Manufacturing Organizations in the External Manufacturing (ExM) space. The incumbent collaborates with other functions (Quality, Operations, Supply Chain, Procurement) and specialist centers of excellence in the Science & Technology network where needed.
・Working under general scientific and administrative direction, this packaging engineer leverages experience gained on scientific, technical, and business issues, to lead the technical interface between our Company and packaging project teams and advise technical staff to solve complex packaging problems. The ability to apply these in a fast-paced Technical Operations environment to resolve issues and meet customer needs in a compliant manner are at the core of this position. The incumbent generates and analyzes scientific data, reports the resulting information, and captures and disseminates knowledge in standard format for current and future use. The position requires advanced knowledge, skills, and abilities to create and optimize business, technical, and compliance processes. Effective leadership of, or collaboration with, high-impact, complex cross-functional and cross-divisional teams and initiatives is needed.
Some key areas of responsibility include:
Technology transfers, Qualifications, Validations, Process Improvements, and Change Control;
Assurance of compliant packaging process execution;
Functioning independently and providing coordination, communication, and oversight on all technical matters pertaining to the external packaging partners;
Technical aspects of fact finding around quality and supply investigations, including leading root cause analyses and developing robust preventive actions;
As a member of the ExM Packaging Focus Factory team (Operations, Quality, Technology), establishing a calibrated technical oversight approach based on the product type, as well as the capabilities and technical competence of an external partner;
As a member of the ExM Packaging Focus Factory team, establishing clear expectations, measures and periodic monitoring of operational and quality performance associated with external packaging partners;
Providing technical expert consultation and review on commercial agreements;
Supporting technical due diligence assessments;
Assuring technical site readiness for all new product introductions or transfers;
Participating in periodic Business Review Meetings with external packaging partners;
Leading complex changes of packaging images and primary, secondary, and tertiary materials/components;
Qualification of changes to distribution and thermal transport/storage systems and methods for finished drug products;
Qualification of functional aspects of container closure systems, such as Child Resistance.
・BS degree in Packaging Science, Mechanical Engineering, Chemical Engineering, Materials Science, or similar
・10+ years of experience in a regulated environment.
・5+ years of hands-on experience with packaging operations support, packaging materials/components, Packaging design, development, engineering and packaging processes.
・2+ years of experience in a pharmaceutical site or External Manufacturing role (Packaging, Operations, Technology, or Quality).
・Knowledge in the regulations of major markets in the Pharmaceutical industry, e.g. USFDA cGMPs, EMA.
・Project management skills, from conception and initiation, through close-out.
・Significant experience with packaging operations support, packaging materials/ components, and packaging processes.
・Demonstrates Leadership Behaviors and Inclusive Behaviors.
・Experience using quantitative decision tools for Risk Management and options analysis.
・Takes an end-to-end view of the supply chain to understand upstream/ downstream impact of actions taken at any node.
・Experience leading diverse and cross-functional teams.
・The engineer applies the following competencies in a manner that challenges and enhances overall operational effectiveness and routinely provides feedback and coaching to team members and collaborators on these skills:
・Completes activities with the highest regard for all Company divisional and local site procedures for safety, quality, and regulatory compliance.
・Excellent oral and written communication skills
・Proven ability to provide technical leadership and apply technical skills in a fast-paced, complex environment.
・In depth understanding and proven expertise in application of GMP’s, quality systems, especially technical subsystems related to process and equipment qualification, change control, deviation management and cleaning qualification.
・Experience with parenteral packaging.
・Experience with combination product packaging.
・Demonstrated deep technical skills in the area of packaging operations.
・Experience with key manufacturing compliance and business systems:
・Trackwise change owner, MIDAS, SAP, Tracelink.
・Experience leading technical transfers.