1+ months

Manager, MDCP External Supply Support

Pfizer
Puurs
**Why Patients Need You** Whether you are involved in the design and development of products, manufacturing processes for products or supporting maintenance and reliability, engineering is vital to making sure customers and patients have the medicines they need, when they need them. Working with our innovative engineering team, you'll help bring medicines to the world even faster by imagining what's possible and taking action.



**What You Will Achieve** Working with Pfizer's dynamic engineering team, you will play a critical role in the design and development of Medical Device and Combination Products and associated manufacturing processes to bring products from research to manufacturing. You will leverage your technical capabilities to understand the inherent problems of transfer of technology from the research stage to manufacturing, in cooperation with R&D, Operations and Contract Manufacturing Organizations. You will support project teams for new product development as well as support on-market products.

As a Manager, your planning skills will help in preparing forecasts for resource requirements, and providing areas of improvement for products, processes or services. Through your comprehensive knowledge of principles, concepts and theories of engineering, you will also work towards advancing new concepts and methodologies. You will be able to take a leadership role to facilitate agreements between different teams. See below for more details on expected responsibilities.

It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.



**How You Will Achieve It** **ROLE SUMMARY**



+ Technical leader and/or people manager responsible for Medical Device and Combination Product (MDCP) Device Engineering

+ Responsibilities includes New Product Development/Co-Development, on-market product and process change management support and risk management for Medical Devices and Combination Products manufactured by External Supply partners

+ Scope of role is focused on Global Medical Devices and Combination Products manufactured by Contract Manufacturers (External Supply or ES) on behalf of Pfizer

+ Center-function role with cross-functional interfaces, including Pfizer Global Supply (PGS) External Supply Operations, Quality and Global Technology & Engineering Device Engineering



**ROLE RESPONSIBILITIES**



+ Support development of strategy to assess and manage risks related to Design and Process robustness for products manufactured by External Supply partners

+ Coach, guide and influence Contract Manufacturers (CMOs) in effective management of MDCP's with respect to industry best practices, e.g. Design & Development, device manufacturing Process Validation and Risk Management

+ Provide technical support for design changes, good documentation practices, process changes, product risk management as related to External Supply manufacturing & supply-chain considerations

+ Develop preliminary design impact assessments for change requests related to device/combo products manufactured by External Supply; develop execution plan and/or coordinate with operations, engineering and validation to implement or qualify changes

+ Identify opportunities for design or process improvement, develop and execute project plans for implementation

+ Support CMO assessment and selection process in early stage product development

+ Support CMO root-cause analysis and troubleshooting for supply-continuity issues related to MDCP components/products

+ Coordinate technical support for MDCP remediation initiatives (plan and execute studies; write technical reports summarizing results; generating / organizing necessary data to support product impact assessments, etc.) as needed

+ May manage direct or indirect reports or contingent workers through a matrix organization

+ Support investigations of customer complaints related to MDCP's for complaints that may be design-related, coordinating with CMO's as needed

+ Identify, communicate, and develop mitigation strategies for technical risks with key stakeholders per appropriate escalation thresholding

+ Identify Design History File (DHF) enhancements / updates and collaborate with Engineering Lifecycle Management for implementation in ES network

+ Collaborates with External Supply Quality colleagues on product and process change management and risk management activities for product lifecycle

+ Contributor to Annual Product Record Review

+ Represent device engineering on change / CAPA review board as needed

+ Supports site readiness for new product introduction and launch at CMO



**Qualifications**

**Must-Have**



+ Bachelor's Degree in Packaging/Mechanical/Chemical Engineering or related technical discipline.

+ 8+ years of experience in Medical Device or Combination Products Design Controls, Production, Quality Engineering or related area

+ Ability to work independently and as a member of a team and in collaboration with other functional groups

+ Strong technical knowledge of complex Medical Device and/or Combination Products technologies

+ Ability to advance new processes and moderately complex methodologies

+ Leverages excellent interpersonal and communications skills to review, discuss, and inform key stakeholders of concepts to drive informed decisions

+ Analyzes complex technical issues and uses technical judgment to impact decision

+ Agile learner of new processes and capable of developing immature processes

+ Knowledge of regulations and ability to work within complex quality system requirements (design controls)

+ Strong technical, critical thinking, and problem-solving skills

+ Understanding of production and production systems in a GMP regulated environment

+ Ability to build effective relationships with key supply chain partners

+ Demonstrated experience in project planning, management, and budgeting with an orientation towards building and leading effective teams



**Nice-to-Have**



+ Advanced degree preferred

+ Experience with supplier/vendor management

+ Relevant pharmaceutical experience

+ Practical experience in facilitating and conducting risk assessments



De Pfizer site in Puurs is n van de grootste productie- en verpakkingssites van Pfizer wereldwijd, gespecialiseerd in aseptische productie en verpakking. Jaarlijks worden in Puurs meer dan 400 miljoen doses injecteerbare vaccins en medicijnen geproduceerd. Deze zijn ter plaatse verpakt in ampullen, flacons, plastic flessen, spuiten en patronen voor pennen.



De medicijnen die in Puurs worden gemaakt, zijn bestemd voor patinten in meer dan 170 landen wereldwijd. 30% van de productie uit Puurs is bestemd voor ontwikkelingslanden, in samenwerking met UNICEF, WHO, GAVI en ngo's. In Puurs werken meer dan 2800 medewerkers.

Met het gebruik van twee windturbines, zonnepanelen en een warmtekrachtcentrale richten we ons op hernieuwbare energie.



Engineering



\#LI-PFE

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Posted: 2021-01-18 Expires: 2021-03-19

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Manager, MDCP External Supply Support

Pfizer
Puurs

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