About this role
Senior Plant Systems Engineer responsible for designing and implementing manufacturing systems for the Therapeutics Development & Supply (TDS) pilot plants, with emphasis on MES, PI/SEEQ data platforms, and data-driven decision making.
Key Responsibilities
- Design & implement plant systems landscape (MES, PI, Seeq)
- Data lifecycle management
- Collaborate with scientists, engineers, and IT
- Vendor management
- Regulatory, audit & SOP management
Technical Overview
Scope includes embedded manufacturing software, data analytics, and regulatory-compliant system lifecycle. Stack centers on MES (Korber PAS-X), AVEVA PI Historian, and Seeq with PLC-based automation and ISA S88/S95 standards.
Ideal Candidate
The ideal candidate is a senior plant systems engineer with 6+ years in pharmaceutical/biotech environments, highly experienced with MES (Korber PAS-X), data historians (AVEVA PI), and Seeq. They should excel at data-driven manufacturing decisions, regulatory readiness, and cross-functional leadership across IT, manufacturing, and quality.
Must-Have Skills
Bachelor's degree or higher in Chemical EngineeringChemistryPharmaInformation Technology or related sciences/engineering disciplinesMinimum of 6+ years of relevant industry experience in pharmaceuticalbiotechor related sectorsHands-on experience with MES (Korber PAS-X)Historian (AVEVA-PI)or Advanced analytics (SEEQ)Experience with PLC-controlled equipmentprocess automation hardware and softwareOT networks infrastructure and systems is highly preferredThorough knowledge of ISA S88/S95 standardsGMP and GAMP requirementsHands-on experience with advanced data analytics relevant to pharmaceutical development (at least two of the following areas): plant systemsprocess analyticsor digital tools
Nice-to-Have Skills
Model-Based Systems Engineering (MBSE)Scripting LanguagesSAP Product Lifecycle ManagementSoftware ArchitectureSystems Development Lifecycle (SDLC)Software Quality Assurance (SQA)RegulatoryAudit & SOP management supportVendor management
Tools & Platforms
Korber PAS-XAVEVA PISeeq
Required Skills
mes (korber pas-x)historian (aveva-pi)seeqplcprocess automationot networksisa s88isa s95gmpgampsdlcfair data principlesdata lifecycle managementdata integrationregulatory inspectionsvalidationsop lifecycle managementvendor management
Hard Skills
MES (Korber PAS-X)Historian (AVEVA-PI)AVEVA PI HistorianSEEQPLCProcess automationOT networksISA S88ISA S95GMPGAMPSDLCFAIR data principlesData Lifecycle ManagementData integration
Soft Skills
Problem-solvingCross-functional collaborationCommunicationStrategic thinkingLeadershipProject management
Keywords for Your Resume
Senior Plant Systems EngineerPlant Systems EngineerMES (Korber PAS-X)Korber PAS-XHistorian (AVEVA-PI)AVEVA-PI HistorianSEEQPLCProcess automationOT networksISA S88ISA S95GMPGAMPSDLCFAIR data principlesData Lifecycle ManagementData integrationRegulatory inspectionsValidationTech transferSOP lifecycle managementVendor managementISA S88/S95Data analytics
Deal Breakers
Less than 6 years of relevant experience, No experience with MES (Korber PAS-X) or AVEVA PI/SEEQ, Lack of ISA S88/S95 knowledge, No GMP/GAMP understanding
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