Merck
Associate Director, Engineering - Packaging Technology
Merck, West Point, Alabama, United States
Overview
Associate Director, Engineering - Packaging Technology role at Merck. Job Description
This role serves as an essential part of the External Manufacturing & Network Equipment team, providing technical leadership and support to Merck's internal and external packaging network. Responsibilities include developing and executing packaging and device assembly equipment and processes, including packaging equipment design and development, ensuring packaging process control and efficiency, and providing ongoing packaging and device technical support across the lifecycle. The Packaging Technical Operations organization aims to be an industry leader in solving problems and delivering robust technical solutions to accelerate product commercialization while ensuring an uninterrupted, compliant supply of products for patients. The Associate Director of Equipment Engineering leads cross-functional projects and possesses deep process and equipment technical expertise for packaging and/or assembly, strong problem-solving skills, strategic acumen, and execution capability. Responsibilities
Lead or support complex technical projects and equipment technology assessments within the packaging and Medical Devices & Combination Products space as part of new product introductions, product source changes, and device component source changes. Lead or support global and site-centric capital and equipment projects, including new packaging equipment purchases, packaging equipment transfer/relocation, device component source changes, and site operational and launch support (approximately 30% travel on average). Serve as the above-site packaging and assembly equipment SME; provide technical support for troubleshooting packaging operations, equipment, and End-to-End line performance and technology analysis (continuous improvement, root cause analysis, equipment capability assessments). Apply packaging scientific/technical concepts (mechanical and electrical knowledge, automation, CAD proficiency, validation and qualification, Lean/Six Sigma, GMP, safety standards, project management, maintenance, serialization, VOC, process capability, root cause analysis, etc.) to resolve packaging issues. Collaborate with Serialization CoE on serialization strategy and provide SME support to internal packaging sites in North America for implementation and troubleshooting. Establish and maintain packaging equipment specification standards across multiple packaging platforms (e.g., Bottle, Blister, Vial, Pre-filled syringe, Autoinjector) and evaluate new technologies for compatibility with existing lines. Education Minimum Requirement
Bachelor’s degree in Packaging Science/Engineering, Mechanical Engineering, or a related technical discipline (e.g., Chemical Engineering or Material Engineering) is mandatory. Required Experience And Qualifications
Minimum of 10 years’ experience in the pharmaceutical, biotechnology, or medical device industry, with 3–5 years in a leadership role (maintenance, operation and/or engineering). Experience developing and implementing equipment standards across multiple manufacturing or packaging sites; extensive knowledge in packaging equipment design, development, and qualification. Strong background in medical devices, combination products, pharmaceutical packaging equipment, and related scientific/technical concepts. Experience with device and combination product design control to product and technology transfer for new and existing facilities. Exceptional project management skills from conception to close-out. Thorough knowledge of GMP, quality systems, process/ equipment qualification & validation, root cause analysis, change control, deviation management, and cleaning validation. Expert in mechanical and electrical concepts, automation, CAD (AutoCAD/SolidWorks), equipment validation/qualification, Lean/Six Sigma, GMP, safety standards, project management, maintenance strategies, serialization, process capability, and root cause analysis. Experience with quantitative decision tools for root cause analysis, risk management, and options analysis. Demonstrated leadership, collaboration, adaptability, and accountability in cross-functional teams; ability to work in fast-paced environments while maintaining compliance. Strong knowledge of cGMP, FDA, EMA, and other regulatory requirements; excellent oral and written communication skills. Equal Opportunity and Compliance
As an Equal Employment Opportunity Employer, Merck provides equal opportunities to all employees and applicants and prohibits discrimination on the basis of protected characteristics. If you need an accommodation during the application or hiring process, please request it. US and Puerto Rico residents only. Merck maintains a hybrid work model for eligible roles, with details provided in the posting. Travel required up to 25%. Visa sponsorship not available for this role. This position is Regular employment with domestic relocation. Salary range: $126,500.00 - $199,100.00. Eligible for annual bonus and long-term incentive where applicable. Benefits include medical, dental, vision, retirement plans (401(k)), holidays, vacation, and other leave. More information is available at Merck’s compensation and benefits page. Application: You can apply for this role through Merck’s careers site or via the Workday Jobs Hub if you are a current employee. The posting end date is listed in the job poster.
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Associate Director, Engineering - Packaging Technology role at Merck. Job Description
This role serves as an essential part of the External Manufacturing & Network Equipment team, providing technical leadership and support to Merck's internal and external packaging network. Responsibilities include developing and executing packaging and device assembly equipment and processes, including packaging equipment design and development, ensuring packaging process control and efficiency, and providing ongoing packaging and device technical support across the lifecycle. The Packaging Technical Operations organization aims to be an industry leader in solving problems and delivering robust technical solutions to accelerate product commercialization while ensuring an uninterrupted, compliant supply of products for patients. The Associate Director of Equipment Engineering leads cross-functional projects and possesses deep process and equipment technical expertise for packaging and/or assembly, strong problem-solving skills, strategic acumen, and execution capability. Responsibilities
Lead or support complex technical projects and equipment technology assessments within the packaging and Medical Devices & Combination Products space as part of new product introductions, product source changes, and device component source changes. Lead or support global and site-centric capital and equipment projects, including new packaging equipment purchases, packaging equipment transfer/relocation, device component source changes, and site operational and launch support (approximately 30% travel on average). Serve as the above-site packaging and assembly equipment SME; provide technical support for troubleshooting packaging operations, equipment, and End-to-End line performance and technology analysis (continuous improvement, root cause analysis, equipment capability assessments). Apply packaging scientific/technical concepts (mechanical and electrical knowledge, automation, CAD proficiency, validation and qualification, Lean/Six Sigma, GMP, safety standards, project management, maintenance, serialization, VOC, process capability, root cause analysis, etc.) to resolve packaging issues. Collaborate with Serialization CoE on serialization strategy and provide SME support to internal packaging sites in North America for implementation and troubleshooting. Establish and maintain packaging equipment specification standards across multiple packaging platforms (e.g., Bottle, Blister, Vial, Pre-filled syringe, Autoinjector) and evaluate new technologies for compatibility with existing lines. Education Minimum Requirement
Bachelor’s degree in Packaging Science/Engineering, Mechanical Engineering, or a related technical discipline (e.g., Chemical Engineering or Material Engineering) is mandatory. Required Experience And Qualifications
Minimum of 10 years’ experience in the pharmaceutical, biotechnology, or medical device industry, with 3–5 years in a leadership role (maintenance, operation and/or engineering). Experience developing and implementing equipment standards across multiple manufacturing or packaging sites; extensive knowledge in packaging equipment design, development, and qualification. Strong background in medical devices, combination products, pharmaceutical packaging equipment, and related scientific/technical concepts. Experience with device and combination product design control to product and technology transfer for new and existing facilities. Exceptional project management skills from conception to close-out. Thorough knowledge of GMP, quality systems, process/ equipment qualification & validation, root cause analysis, change control, deviation management, and cleaning validation. Expert in mechanical and electrical concepts, automation, CAD (AutoCAD/SolidWorks), equipment validation/qualification, Lean/Six Sigma, GMP, safety standards, project management, maintenance strategies, serialization, process capability, and root cause analysis. Experience with quantitative decision tools for root cause analysis, risk management, and options analysis. Demonstrated leadership, collaboration, adaptability, and accountability in cross-functional teams; ability to work in fast-paced environments while maintaining compliance. Strong knowledge of cGMP, FDA, EMA, and other regulatory requirements; excellent oral and written communication skills. Equal Opportunity and Compliance
As an Equal Employment Opportunity Employer, Merck provides equal opportunities to all employees and applicants and prohibits discrimination on the basis of protected characteristics. If you need an accommodation during the application or hiring process, please request it. US and Puerto Rico residents only. Merck maintains a hybrid work model for eligible roles, with details provided in the posting. Travel required up to 25%. Visa sponsorship not available for this role. This position is Regular employment with domestic relocation. Salary range: $126,500.00 - $199,100.00. Eligible for annual bonus and long-term incentive where applicable. Benefits include medical, dental, vision, retirement plans (401(k)), holidays, vacation, and other leave. More information is available at Merck’s compensation and benefits page. Application: You can apply for this role through Merck’s careers site or via the Workday Jobs Hub if you are a current employee. The posting end date is listed in the job poster.
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