AD Packaging Engineering, Medical - Global Devices
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Job Description
Are you driven by the complexities of product and technology transfers? Does leading technical interactions with external packaging partners excite you? If solving intricate packaging issues, optimizing processes, and ensuring compliance is where you thrive, then our company, a leading research-intensive biopharmaceutical company, eagerly awaits your expertise for our External Manufacturing & Network Equipment team.
Your Core Responsibilities
* Lead and manage technology transfers, qualifications, validations, and process improvements for Small and Large Molecule projects, medical devices, and combination products.
* Ensure compliant and efficient process transfers, site readiness, and execution excellence in packaging and assembly.
* Coordinate, communicate, and supervise technical issues with external packaging partners.
* Provide technical expertise in quality and supply investigations involving external packaging partners.
* Establish a calibrated technical oversight approach based on product type and partner capabilities to ensure scientific rigor and execution excellence.
* Monitor operational and quality performance of external packaging partners, setting expectations and metrics.
* Conduct technical evaluations of external packaging partners and create assessments during the selection process.
* Lead complex changes in packaging images and materials, oversee qualification of modifications to distribution and thermal transport/storage methods.
Who You Are
You are ready if you have:
* A proactive problem solver with a Bachelor’s degree in Packaging Science/Engineering, Mechanical Engineering, or a related field.
* Minimum of 10 years’ experience in medical device or pharmaceutical packaging engineering, with extensive knowledge of packaging assembly operations and materials management.
* Leadership experience at a pharmaceutical packaging facility or external manufacturing site.
* Experience with capital packaging equipment projects, including technology transfers, designing packaging lines, managing installation, validation, and troubleshooting.
* Broad experience with devices and combination products, covering design control to technology transfer.
* Exceptional project management skills from conception to closeout.
* Thorough knowledge of GMP, quality systems, process and equipment qualification, change control, deviation management, and cleaning qualification.
* Technical expertise to handle routine and complex tasks, with advanced practical knowledge of relevant techniques.
Note: You must be based in the specified locations, willing to travel up to 25% within Europe, with some flexibility regarding other locations.
Additional Information
Current Employees apply HERE
Current Contingent Workers apply HERE
We are committed to 'Inventing for Life' and embracing diversity. We support flexible working and a hybrid work model. Please discuss your flexibility needs during your application.
If you're ready to invent solutions for unmet healthcare needs, please apply today.
Important Notices
Merck & Co., Inc. does not accept unsolicited agency resumes without a valid agreement. No fee will be paid if a candidate is hired through an agency without an agreement.
Employee Status: Regular
Employment Type: Full-time
Job Function: Production, Manufacturing, and Engineering
Industries: Biotechnology Research, Pharmaceutical Manufacturing, Veterinary Services
Application deadline: 06/30/2025
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