Planet Pharma
MES Engineer
Planet Pharma, Philadelphia, Pennsylvania, us, 19019
OverviewThis position reports to the Manager, IT Manufacturing Systems. The MES (manufacturing execution system) engineer will serve as a technical resource, providing operational support, performing configuration/documentation updates, and maintaining the Syncade Manufacturing Execution System (MES). This role will utilize their Emerson Syncade MES expertise within manufacturing, quality and supply chain information systems to continue digitalization and operational support of the manufacturing site. As well as being an operational and application support resource, the role will partner with the functions (Manufacturing, Quality, MSAT, R&D) to ensure IT at is maintaining and delivering systems the business utilizes.
Essential Functions and ResponsibilitiesPerform general engineering tasks related to MES, as delegated by the system owner (IT Manager), such as Recipe Authoring, Equipment Tracking configuration, administration-level configuration updates, report configuration (Crystal Reports), data mining (SQL query authoring), etc.Assist team with operational activities (e.g. end-user support, break-fix) for all aspects of MES system (Equipment Tracking/Workflows, Order/Inventory Management, interface to ERP, etc.) – on-call support required.Act as technical resource for major MES projects (upgrade/migration, equipment state tracking, electronic batch record).Knowledge of pharmaceutical business processes, Part 11 data integrity, infrastructure, architecture, and technology to support business supporting manufacturing.Partner with business teams, learn business processes and drive continuous improvement initiatives to provide operational efficiencies and cost reductions.Adhere to core values, policies, procedures, and business ethics.
Travel and on-site requirementsTravel requirements less than 10%On-site at Philadelphia manufacturing facility > 80%
Required Education, Skills, and KnowledgeBachelor's degree required, preferably in Computer Science, Engineering, Chemical/Biomedical Engineering, or similar field of studyExperience in pharmaceutical and/or medical device industries.
Preferred Education, Skills, and KnowledgeAt least 2-4 years of hands-on experience and exposure working in biotech/pharma information technology.Experience implementing and administering MES (Emerson Syncade)Familiarity with the back-end design, operation and the supporting database structure of Syncade MES is a plus.Experience with additional systems including ERP (NetSuite), Building Management and Environmental Monitoring (Siemens Desigo), LIMS (Labvantage) and CMMS (Blue Mountain) is a plus.Experience with Computer System Validation (CSV) is highly preferred.Experience with cell and gene therapy manufacturing preferred.Experience in FDA regulated industry and familiarity with CFR 21 Part 11, cGMP.Strong interpersonal, presentation and communication skills.Possesses sense of urgency; identifies challenges and problems and takes the initiative to identify solutions.Can work as an effective team resource as well as independently.
The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodation may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request accommodation.
Essential Functions and ResponsibilitiesPerform general engineering tasks related to MES, as delegated by the system owner (IT Manager), such as Recipe Authoring, Equipment Tracking configuration, administration-level configuration updates, report configuration (Crystal Reports), data mining (SQL query authoring), etc.Assist team with operational activities (e.g. end-user support, break-fix) for all aspects of MES system (Equipment Tracking/Workflows, Order/Inventory Management, interface to ERP, etc.) – on-call support required.Act as technical resource for major MES projects (upgrade/migration, equipment state tracking, electronic batch record).Knowledge of pharmaceutical business processes, Part 11 data integrity, infrastructure, architecture, and technology to support business supporting manufacturing.Partner with business teams, learn business processes and drive continuous improvement initiatives to provide operational efficiencies and cost reductions.Adhere to core values, policies, procedures, and business ethics.
Travel and on-site requirementsTravel requirements less than 10%On-site at Philadelphia manufacturing facility > 80%
Required Education, Skills, and KnowledgeBachelor's degree required, preferably in Computer Science, Engineering, Chemical/Biomedical Engineering, or similar field of studyExperience in pharmaceutical and/or medical device industries.
Preferred Education, Skills, and KnowledgeAt least 2-4 years of hands-on experience and exposure working in biotech/pharma information technology.Experience implementing and administering MES (Emerson Syncade)Familiarity with the back-end design, operation and the supporting database structure of Syncade MES is a plus.Experience with additional systems including ERP (NetSuite), Building Management and Environmental Monitoring (Siemens Desigo), LIMS (Labvantage) and CMMS (Blue Mountain) is a plus.Experience with Computer System Validation (CSV) is highly preferred.Experience with cell and gene therapy manufacturing preferred.Experience in FDA regulated industry and familiarity with CFR 21 Part 11, cGMP.Strong interpersonal, presentation and communication skills.Possesses sense of urgency; identifies challenges and problems and takes the initiative to identify solutions.Can work as an effective team resource as well as independently.
The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodation may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request accommodation.