Associate Director, Engineering Technical Operations - Europe, Hybrid

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 

• As part of this role, you get the chance to spearhead and manage technology transfers, qualifications, validations, and process enhancements for Small and Large Molecule projects, medical devices, and combination products. 
• This position invites you to ensure compliant and efficient process transfer, site readiness, and execution excellence in packaging and assembly. 
• You will have the opportunity to independently coordinate, communicate, and supervise technical issues with external packaging partners. 
• Providing technical expertise in quality and supply investigations involving external packaging partners will be one of your key responsibilities. 
• You will be tasked with establishing a calibrated technical oversight approach based on product type and external partner's capabilities to drive scientific rigor and execution excellence. 
• This role gives you the chance to monitor operational and quality performance of external packaging partners, setting clear expectations and establishing metrics. 
• You will conduct technical evaluations of external packaging partners and create comprehensive assessments during the selection phase. 
• Leading complex changes in packaging images and materials/components, and overseeing the qualification of modifications to distribution and thermal transport/storage methods will be part of your exciting journey with us. 

Who You Are 

You are ready if you have: 

• We are seeking a proactive problem solver with a Bachelor’s degree in Packaging Science/Engineering, Mechanical Engineering, or a related technical discipline. 
• You must bring along a minimum of 10 years’ experience in the medical device or combination product engineering and pharmaceutical field, with extensive knowledge in supporting packaging assembly operations and managing packaging materials and components. 
• Leadership experience at a pharmaceutical packaging facility or an External Manufacturing site is highly valued. 
• We expect a vast experience in handling Capital packaging equipment projects, including technology transfers, designing packaging lines, managing equipment installation and validation, and troubleshooting on the shop floor. 
• We appreciate a 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 closeout are a must. 
• We value a 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 is preferred. 

 To note you must be based in the locations highlighted but can be based anywhere in that country. You need to travel up to 25% of the time to our external manufacturing sites in Europe. Some flexibility on other European locations.