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Process Engineering; Sterile Injectable SME (Any Pfizer Manufacturing location)


Castle Rock, CO 80104
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Job Details

**Closing date for applications** : 16th April 2018

**Role Description**

Responsible for providing Process Engineering technical support across the Pfizer Global Supply (PGS) network and capital project portfolio.

The role will be primarily focused on the Aseptic and Sterile Injectable technologies. The Process Engineering and Analytics team provides Subject Matter Expert (SME) input into process engineering, process modelling and data analytics support to API, Biologics, Sterile Injectable and Solids process operations throughout Pfizer in support of PGS. The purpose of this role is to provide Aseptic/Sterile Injectable specific process engineering and equipment knowledge into production facility designs, process equipment selection, process design, operational troubleshooting and ongoing operational support across all Sterile/Aseptic operations (including DS and DP processing)

Value Proposition.

Provide process and equipment engineering SME input into the Pfizer Aseptic/Sterile Injectable network ensuring best known methods and state of the art design practices are used. Providing the linkage between multiple projects and leveraging the wider network experience to ensure both robust and reliable aseptic/sterile processing throughout the network.

Location for this role is flexible, will consider any PGS HQ or Manufacturing site locations.


+ New Technology - Develop & evaluate new technologies related to sterile and aseptic processing

+ Provide technical guidance to the PGS network in relation to:

+ Development of site equipment master plans with a longer-term focus (typically 3 to 5 years) based on the organization's vision.

+ Equipment Selection - Identify suitable technologies & suppliers to meet user requirements, support new product launches and on-going capital investments

+ Support the development of validation plans related to sterilization and Aseptic processing of products.

+ Support product submissions/filings/dossiers for sterilization and aseptic processing related sections (example CTD 3.2.P.3)

+ Provide SME support for regulatory actions (internal and external) and provide recommendations for process/procedure updates.

+ Design and execute sterilization development studies to support current process/products, as appropriate

+ Equipment knowledge & SME input related to sterilization/aseptic operations

+ Troubleshooting - Provide technical support for major supply or quality issues relative to sterilization and aseptic process related issues for product and/or processes

+ Partner with MAS in development/revisions of internal PQS & GPB documents.

+ Play an active role in promoting knowledge sharing and technology replication by participating in a broad range of global network teams (CIGs/COPs), user groups, network strategies, vendor technology meetings, etc.

+ Promote an Innovation Culture leveraging Innovation tools and behaviours

+ Vendor Relationships / Management - Strengthen partnerships with key vendors to facilitate issue resolution, after sales support, etc.

+ Communicate proactively with stakeholders, senior leaders and sites regarding activities, progress, issues and resolution plans related to supported activities.

+ Collaborate with process automation, equipment engineering, and other technical groups in GTS, PGS sites and WRD to optimize process robustness and asset performance

+ Partner with GTS and Pharmaceutical Sciences on the development and introduction of innovative technical solutions and platform technologies

+ Support development and application of tools and systems to enhance product and process knowledge throughout the product lifecycle.


Bachelor Degree in Engineering or equivalent scientific discipline

Master Degree in Engineering or

5 - 10 years of experience in the Pharmaceutical / Biologics Manufacturing operations with an in depth knowledge of Aseptic/Sterile Injectable processes and regulatory requirements.

Proven ability to work in a cross cultural environment and provide technical leadership while working remotely is required.

Technical Skills:

+ Extensive background in Aseptic/Sterile Injectable processes and a clear understanding of the associated regulatory requirements.

+ Exceptional communication skills and the ability to build relationships with colleagues across all levels of the organization, including business managers, operations leaders and technical leaders.

+ Ability to lead technical programs and initiatives, fostering support from stakeholders and collaboration among participants.

+ Proven ability to work in a cross cultural environment and provide technical leadership while working remotely is a requirement.

+ Expected to continue to develop skills to maintain subject matter expertise.

Physical Position Requirements:

Located at PGS Manufacturing Site

Up to 35% overnight travel including international locations

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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