Associate Director, Packaging Engineering – External Manufacturing

Job Description

Job Description:

This role serves as an essential part of the External Manufacturing & Network Equipment team overseeing product and technology transfers to Contract Manufacturing Organizations (CMOs). The role involves leading technical interactions with external packaging partners which are Contract Manufacturing Organizations in the ExM space. You will work closely with other ExM functions (Quality Operations Supply Chain Procurement) and technology experts within the Centers of Excellence. The engineer will leverage their scientific technical and business expertise to lead teams in solving complex packaging issues optimizing processes and ensuring compliance focusing on developing and executing primary and secondary packaging components for Small and Large Molecule assets assembling Medical Device Combination Products designing packaging equipment and ensuring packaging process control and efficiency. Effective collaboration with teams is crucial to achieving the companies goals. The position requires advanced skills in creating and improving business technical and compliance processes and leading high-impact cross-functional teams.

Essential Duties and Responsibilities:

• Tasked with leading and implementing technology transfers qualifications validations process enhancements and change controls for projects involving Small and Large Molecule and medical devices and combination products.

• Assurance of compliant packaging and assembly process transfer site readiness and execution excellence.

• Operating autonomously to offer strong coordination communication and supervision on all technical issues related to the responsible external packaging partners.

• Offer technical expertise in quality and supply investigations with external packaging partners. Lead discussions on packaging processes equipment and components to help identify root causes and develop effective corrective and 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 to drive scientific rigor and execution excellence.

• As part of the ExM Focus Factory team setting clear expectations establishing metrics and regularly monitoring both operational and quality performance related to external packaging partners.

• Conduct all technical evaluations of external packaging partners and create comprehensive technical assessments during the final selection phase.

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

• Leading complex changes of packaging images and primary secondary and tertiary materials/components.

• Oversee the qualification of relevant modifications to distribution and thermal transport/storage methods for finished packaging configurations.

• Offer technical guidance to support the commercial agreements between ExM and the external packaging partner.

Required Experience and Qualifications:

• Minimum of 10 years experience in the medical device or combination product engineering and pharmaceutical field with extensive practical knowledge in supporting packaging operations managing packaging materials and components and overseeing packaging processes.

• Strong preference for candidates with leadership experience at a pharmaceutical packaging facility or an External Manufacturing site.

• Extensive experience in handling Capital packaging equipment projects including technology transfers designing packaging lines creating purchase specifications managing equipment installation and validation pursuing operational excellence and troubleshooting on the shop floor.

• 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 change control deviation management and cleaning qualification.

• Expert grasp of relevant scientific or technical concepts to handle routine and complex tasks along with advanced practical knowledge of techniques applicable to these tasks.

• Experience with key manufacturing change control compliance systems such as Veeva and/or other similar systems

• Extensive experience with quantitative decision tools for risk management and options analysis to support risk-based decision making.

• Exhibited leadership qualities and inclusive practices in managing a diverse cross-functional team.

• Familiarity with the regulatory standards of key pharmaceutical markets such as USFDA cGMPs and EMA guidelines.

• Demonstrate ability to have a continuous learning mindset and commitment to experiment learn and embrace informed risk taking and doing things in new ways without fear of failure.

• Adopt a critical mindset in decision-making to ensure thorough analysis while considering potential impacts on key stakeholders.

• Ability to serve as a change agent to work collaboratively and act with an enterprise mindset to make appropriate tradeoffs for the project & organizations greater good.

• Strong analytical and decision-making abilities combined with outstanding oral and written communication skills.

Education Minimum Requirement:

• A bachelors degree in Packaging Science/Engineering Mechanical Engineering or a related technical discipline (such as Chemical Engineering or Material Engineering) is mandatory.

Required Skills:

Preferred Skills:

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