Senior Specialist, Engineering - Packaging

Job Description

Position Description

This position is a key member of the External Manufacturing & Network Equipment team that will be responsible for leading product/technology transfers to Contract Manufacturing Organizations (CMO) and to serve as a key technical interface liaison with our Company internal packaging sites in the areas of packaging equipment design/development, packaging process and controls and packaging operation.

Under general scientific and administrative direction, the engineer leverages experience gained on scientific, technical, and business issues, to lead project teams and technical staff to solve complex packaging problems. The engineer will demonstrate knowledge, skills and abilities to optimize business, technical, and compliance processes.  The person in this position participates in high impact, complex cross-functional and cross-divisional teams and initiatives and provides leadership to achieve project goals.  Effective collaboration with teams is essential to meet our Company's goals/objectives.  The ability to apply these skills 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. 

Some key areas of responsibility include:

• As part of the ExM & Network Equipment team, establishing a calibrated technical oversight approach based on the product type, as well as the capabilities and technical competence of an external partner;

• Technology & Product Transfers, Qualifications, Validations, Process Improvements, and Change Control;

• Assurance of compliant packaging process execution and project management;

• 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;

• Significant experience with packaging operations support, packaging development, packaging materials, packaging equipment and packaging processes;

• Supporting technical due diligence assessments;

• Assuring technical site readiness for all new product introductions or technology transfers;

• Participating in periodic Business Review Meetings with external packaging partners;

• Leading complex changes of packaging images and primary, secondary, and tertiary materials;

• 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.

Education Minimum Requirement:

• BS degree in Packaging Science, Mechanical Engineering, Chemical Engineering, Materials Science, or similar

Required Experience and Skills:

• 7+ years of experience working in medical device, pharmaceutical or in biotech organization with hands-on experience with packaging operations support, packaging materials/components, and packaging processes.

• Knowledgeable of design control, medical device, combination products, pharmaceutical packaging and related scientific/technical concepts and techniques are highly desirable.

• Desirable to have prior experiences working inside a pharmaceutical packaging facility or in an External Manufacturing technical role.

• Highly proficiency in project management skills, from conception and initiation, through close-out.

• Has a mastery of packaging scientific/technical concepts and techniques, applies and furthers those concepts and techniques to execute in pursuit of resolving scientific/technical packaging issues.

• Significant experience with medical device or combination product transfer, operations support, and materials/components.

• Experience using quantitative decision tools for Risk Management and options analysis.

• 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.

• General unde