Process Engineering: Sterile Injectable SME

Silverdal / Maskiningenjörsjobb / Strängnäs
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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 Pfizer Global Supply (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.

Responsibilities
• New Technology - Develop & evaluate new technologies related to sterile and aseptic processing
• Provide technical guidance to the PGS network in relation to:
o Development of site equipment master plans with a longer-term focus (typically 3 to 5 years) based on the organization's vision.
o Support the development of validation plans related to sterilization and Aseptic processing of products.
o Support product submissions/filings/dossiers for sterilization and aseptic processing related sections (example CTD 3.2.P.3)
o Provide SME support for regulatory actions (internal and external) and provide recommendations for process/procedure updates.
o Design and execute sterilization development studies to support current process/products, as appropriate
o 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 behaviors
• 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.

Qualifications
• 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.

Pfizer Strängnäs är Sveriges största bioteknikanläggning för kommersiell tillverkning av läkemedelssubstanser med cirka 250 anställda. Vi tillverkar flera läkemedelssubstanser och proteinintermediat i en multiproduktanläggning. Pfizer är ett företag som fokuserar på innovation, kreativitet och respekt för patienter, kollegor och samhället. Hos oss har medarbetarna goda möjligheter att utvecklas och arbeta med globala kontakter.
I Strängnäs har vi en effektiv tillverkningsorganisation med fokus på kontinuerliga förbättringar, Six Sigma och Lean. Vi har nyligen ökat antalet produkter i vår anläggning och vi står inför flera spännande utmaningar och möjligheter att ta in ny teknik för att optimera vår verksamhet.
Vi befinner oss i Strängnäs med bra pendlingsmöjligheter bara 50 minuter från Stockholm city. För mer information om Strängnäs, besök www.strangnas.se.
Då tjänsten är global så är förväntan att man reser c:a 35% av sin tid

Varaktighet, arbetstid
• Located at PGS Manufacturing Site (Strängnäs) * Up to 35% overnight travel including international locations

Publiceringsdatum
2018-10-25

Ersättning
Utöver din månadslön har du även förmåner i form av subventionerad lunch, fri träning på World class i Strängnäs/Mariefred, arbetstidsförkortning, pensions placeringsstöd och en förmånlig sjukvårdsförsäkring. Du ingår också i företagets bonusprogram

Så ansöker du
Sista dag att ansöka är 2018-10-30
Ange följande referens när du ansöker: Job,id: 4718450
Klicka på denna länk för att göra din ansökan

Företag
Silverdal

Adress
Silverdal
Box 108
64522 Strängnäs

Kontorsadress
Mariefredsvägen 37

Jobbnummer
4422788

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