Associate Director, Engineering - Packaging Technology

Merck•Durham, NC

3d•Hybrid

About The Position

This role serves as an essential part of the External Manufacturing & Network Equipment team, in providing technical leadership and support to our company's internal & external packaging network, focusing on developing and executing packaging and device assembly equipment and processes including packaging equipment design & development, ensuring packaging process control and efficiency and providing on-going packaging and device technical support across the lifecycle. The Packaging Technical Operations organization aims to be an industry leader in problem-solving, delivering robust and pragmatic technical solutions to accelerate the commercialization of new products, and ensuring an uninterrupted, compliant supply of commercialized products for the benefit of patients. The Associate Director of Equipment Engineering is integral to this mission. The successful candidate will possess deep process and equipment technical expertise for packaging and/or assembly, a strong track record in problem-solving, strategic acumen, and execution, along with leadership skills to lead complex cross functional projects. Essential Duties and Responsibilities: The engineer will be responsible to leverage their scientific, technical, and business expertise to participate or lead in capital equipment projects, developing network equipment & process standards, solving complex packaging process and equipment issues, optimizing processes, and ensuring compliance. Effective collaboration with site-based and above-site based functional teams is crucial to achieving our company's goals. The position requires advanced skills in creating and improving business, technical, and compliance processes, and leading high-impact cross-functional teams. Responsible to 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. The incumbent will lead or support complex global and site-centric capital and equipment projects. These projects would include new packaging equipment purchases, packaging equipment transfer/relocation, device component source change assessment, and packaging site operational & launch support. This will include approximately 30% travel on average with occasional peaks during critical milestones. Serving as the above-site packaging and assembly equipment SME. Individual will lead or provide direct technical support to the packaging network in areas of trouble shooting of the packaging operation, equipment and End-to-End line performance & technology analysis (i.e., continuous improvement, root cause analysis, equipment technology & capability assessments.) The incumbent will be required to leverage packaging scientific/technical concepts and techniques (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 and etc.)) and effectively apply them in daily work to resolve scientific/technical packaging issues. The successful candidate will be responsible for working closely with our company's Serialization CoE pertaining to our company's serialization strategy and to serve as the SME to collaborate with internal packaging sites, in North America, of its implementation, monitoring and troubleshooting support. The qualified candidate will be accountable to establish and maintain specific packaging equipment specification standards in line with our company's Same-Same component/equipment/process principles across multiple packaging platforms (e.g., Bottle, Blister, Vial, Pre-filled syringe, Autoinjector and etc.) In some cases, the individual will need to evaluate new technologies for compatibility with existing packaging lines and to collaborate closely with package sites’ technology groups to ensure alignment.

Requirements

A bachelor’s degree in Packaging Science/Engineering, Mechanical Engineering, or a related technical discipline (such as Chemical Engineering or Material Engineering) is mandatory.
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 and etc.)) 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 are essential.
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.

Responsibilities

Responsible to 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.
The incumbent will lead or support complex global and site-centric capital and equipment projects. These projects would include new packaging equipment purchases, packaging equipment transfer/relocation, device component source change assessment, and packaging site operational & launch support.
Serving as the above-site packaging and assembly equipment SME. Individual will lead or provide direct technical support to the packaging network in areas of trouble shooting of the packaging operation, equipment and End-to-End line performance & technology analysis (i.e., continuous improvement, root cause analysis, equipment technology & capability assessments.)
The incumbent will be required to leverage packaging scientific/technical concepts and techniques (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 and etc.)) and effectively apply them in daily work to resolve scientific/technical packaging issues.
The successful candidate will be responsible for working closely with our company's Serialization CoE pertaining to our company's serialization strategy and to serve as the SME to collaborate with internal packaging sites, in North America, of its implementation, monitoring and troubleshooting support.
The qualified candidate will be accountable to establish and maintain specific packaging equipment specification standards in line with our company's Same-Same component/equipment/process principles across multiple packaging platforms (e.g., Bottle, Blister, Vial, Pre-filled syringe, Autoinjector and etc.) In some cases, the individual will need to evaluate new technologies for compatibility with existing packaging lines and to collaborate closely with package sites’ technology groups to ensure alignment.

Benefits

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

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