This is a global role as a subject matter expert providing process/equipment guidance into the design and operation of Visual Inspection equipment for Pfizer Global Supply sites and external partners. The primary purpose of this role is to provide strong technical leadership and support the deployment of innovative solutions in support of the Global Sterile Injectables and Biotechnologies Operating Units.
This role will report to the Director, Visual inspection to support strategic initiatives and understand business objectives related to the visual inspection process.
This role will also support strategic direction related to automated visual inspection and related technologies. It will be necessary to partner with equipment and technology vendors to develop solutions for parenteral operations.
The primary function of this role is to facilitate the implementation and use of visual inspection processes and systems by:
- Serve as a business technical representative for visual inspection process-related issues that can have significant business impact
- Serve as business process owner of visual inspection processes and provide SME support for inquiries and investigations.
- Provides technical guidance and support for the design, implementation, qualification, validation and operation of Visual Inspection technologies
- Works with leadership to develop support development of automated visual inspection strategy and direction.
- Provide troubleshooting, root cause analysis serving as scientific and technical subject matter expert on issues that affect Visual Inspection and Container Closure Integrity
- Lead and support strategic visual inspection projects and programs to optimize network resources and costs.
- Manage Implementation of Visual Inspection Technical Transfer to CMOs
- Supports FDA and other regulatory inspections as subject matter expert in AVI technology and related projects.
- Maintains knowledge of contemporary requirements, industry standards and regulatory standards
- Mentor colleagues to develop their capabilities and ensure Visual Inspection program sustainability and continued alignment with Network Standards
- Works independently on most assignments using knowledge and work experience to achieve desired results
- BS or MS in Engineering, business, or Science preferred. Advanced and recent experience with AVI equipment/tuning considered.
- 5 years related experience in the development or support of processes, quality systems or a closely related field
- Excellent communication skills and attention to details.
- Demonstrated ability to be support strategic projects with large multi-discipline teams by developing strategy and leading team through project completion.
- ADDITIONAL SKILLS/PREFERENCES:
- Demonstrated ability to perform as a process leader when interfacing with all areas of Pfizer’s network
- Strong understanding of Visual Inspection and Container Closure Integrity Testing Regulatory requirements
- Strong qualification and validation skills and experience
- In-depth experience in developing, designing, producing, or supporting equipment in a cGMP environment required
- Knowledge of process control, quality engineering, sampling requirements, statistical techniques and process capability.
- Familiarity with relevant quality and regulatory requirements and trends and cGMP’s (e.g. FDA, EU Annex 1, PIC/S, PDA, ISPE, Pfizer PQS, etc.).
- Strong communication skills and the ability to build relationships with colleagues across all levels of the organization, including business managers, operations leaders and technical leaders.
- Knowledge of Aseptic techniques and processing
De Pfizer site in Puurs is één 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 patiënten 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.
Met het gebruik van twee windturbines, zonnepanelen en een warmtekrachtcentrale richten we ons op hernieuwbare energie.