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Co-create MES strategy and roadmap with business partners (Business Process Owner/Manager, Site Stakeholders and MES Core Product Owner) in collaboration with IT Partners (Architects, Global Infrastructure, Business Analysts and MES Core Product Manager) plus external vendors.
Represent and mitigate MES dependencies as related global systems evolve their business processes and technologies (e.g. SAP upgrade & LIMS replacement).
Work to identify opportunities to create additional value and improve business processes and patient outcomes, maximize the benefits of standardization of technologies and leverage across sites.
Determine business criticality and product quality requirements, and in collaboration with Delivery Service Managers, ensure appropriate service levels, Disaster Recovery procedures, governance, change management, compliance and operational support.
Lead or coordinate technical discussions and vendor negotiations.
Lead proposal development for local and global digital governance bodies, collaborate with Site IT Business Partner to meet the needs of the South San Francisco Manufacturing.
Through Agile delivery model, provide leadership, technical expertise and local implementation experience as a member of Build and Run Squads.
In collaboration with IT Business Partners, monitor and improve stakeholder and user experience and ensure strong support of Product Transfers and Make/Assess/Release.
The ideal candidate:
Has business domain knowledge for the following area(s)
Biopharmaceutical or similar Manufacturing domain.
Knowledge of informational and operational technologies (IT OT), MES integration to enterprise systems.
Knowledge of Manufacturing Execution System, Manufacturing Automation, MES integration with enterprise systems like LIMS, Data Historian, ERP etc.
Knowledge of new product introduction, supply chain and manufacturing operations as applicable to MES.
Keep abreast of key Manufacturing IT trends and be curious - Industrial IoT, Manufacturing Digital Plant Maturity, Cybersecurity, Pharma 4.0, Data Integrity principles, technology, and data standardization, etc.
Represent IT OT in cross-functional initiatives at OCN.
Identify application requirements through relationship building & effective stakeholder management.
Collaborate with cross-functional team to oversee software upgrades & releases to MES system.
Prior experience with global core - site solution leveraging, and deployment model is a plus.
Champions PT Informatics Product Management Strategy in implementing global Core Platforms.
Cross-functional experience leading and/or collaborating on projects with specialized application requirement to implement MES solution.
Exhibits intellectual curiosity and integrity and has a strong passion to bring value-adding technology to the business.
Knowledge of Good Manufacturing Practices (GMP), Health Authority practices, 21 CFR Part 11, cGMP Annex 11, Data Integrity principles.
Experience with Automation interventions or shop floor support for system-related issues and discrepancies.
Requirements:
Bachelor’s degree in informatics, Engineering or STEM background.
3+ years of experience in supporting, implementing and managing MES solutions, highly desirable Emerson Syncade, Pharma Suite, Werum PAS-X, Siemens Op Center or extensive experience from other platforms that will accelerate learning on those platforms.
Must have experience in life sciences Manufacturing domain. Exceptions will be made to outstanding candidates.
Prior experience in working closely with IT OT or 3rd party providers/vendors.
Availability to travel up to 10%. Must be open to both domestic and global travel.
Relocation benefits may be available for exceptional candidates.
Email Resumes To: Admin@viperstaffing.com
(Hiring) Manufacturing Execution System (MES) Engineer
Oceanside, CA · Architecture/Engineering(Hiring) (Hiring) Manufacturing Execution System (MES) Engineer
JOB DESCRIPTION
Co-create MES strategy and roadmap with business partners (Business Process Owner/Manager, Site Stakeholders and MES Core Product Owner) in collaboration with IT Partners (Architects, Global Infrastructure, Business Analysts and MES Core Product Manager) plus external vendors.
Represent and mitigate MES dependencies as related global systems evolve their business processes and technologies (e.g. SAP upgrade & LIMS replacement).
Work to identify opportunities to create additional value and improve business processes and patient outcomes, maximize the benefits of standardization of technologies and leverage across sites.
Determine business criticality and product quality requirements, and in collaboration with Delivery Service Managers, ensure appropriate service levels, Disaster Recovery procedures, governance, change management, compliance and operational support.
Lead or coordinate technical discussions and vendor negotiations.
Lead proposal development for local and global digital governance bodies, collaborate with Site IT Business Partner to meet the needs of the South San Francisco Manufacturing.
Through Agile delivery model, provide leadership, technical expertise and local implementation experience as a member of Build and Run Squads.
In collaboration with IT Business Partners, monitor and improve stakeholder and user experience and ensure strong support of Product Transfers and Make/Assess/Release.
The ideal candidate:
Has business domain knowledge for the following area(s)
Biopharmaceutical or similar Manufacturing domain.
Knowledge of informational and operational technologies (IT OT), MES integration to enterprise systems.
Knowledge of Manufacturing Execution System, Manufacturing Automation, MES integration with enterprise systems like LIMS, Data Historian, ERP etc.
Knowledge of new product introduction, supply chain and manufacturing operations as applicable to MES.
Keep abreast of key Manufacturing IT trends and be curious - Industrial IoT, Manufacturing Digital Plant Maturity, Cybersecurity, Pharma 4.0, Data Integrity principles, technology, and data standardization, etc.
Represent IT OT in cross-functional initiatives at OCN.
Identify application requirements through relationship building & effective stakeholder management.
Collaborate with cross-functional team to oversee software upgrades & releases to MES system.
Prior experience with global core - site solution leveraging, and deployment model is a plus.
Champions PT Informatics Product Management Strategy in implementing global Core Platforms.
Cross-functional experience leading and/or collaborating on projects with specialized application requirement to implement MES solution.
Exhibits intellectual curiosity and integrity and has a strong passion to bring value-adding technology to the business.
Knowledge of Good Manufacturing Practices (GMP), Health Authority practices, 21 CFR Part 11, cGMP Annex 11, Data Integrity principles.
Experience with Automation interventions or shop floor support for system-related issues and discrepancies.
Requirements:
Bachelor’s degree in informatics, Engineering or STEM background.
3+ years of experience in supporting, implementing and managing MES solutions, highly desirable Emerson Syncade, Pharma Suite, Werum PAS-X, Siemens Op Center or extensive experience from other platforms that will accelerate learning on those platforms.
Must have experience in life sciences Manufacturing domain. Exceptions will be made to outstanding candidates.
Prior experience in working closely with IT OT or 3rd party providers/vendors.
Availability to travel up to 10%. Must be open to both domestic and global travel.
Relocation benefits may be available for exceptional candidates.
Email Resumes To: Admin@viperstaffing.com