We are seeking an experienced POMS MES Techno-Functional SME with deep expertise in Manufacturing Execution Systems (MES) within a GxP-regulated pharmaceutical manufacturing environment. The ideal candidate will serve as a trusted advisor and bridge between business stakeholders, manufacturing operations, quality organizations, validation teams, and technical delivery teams to support, enhance, configure, and implement POMS MES solutions across manufacturing sites.
This role requires a combination of strong functional knowledge of pharmaceutical manufacturing processes, hands-on POMS MES expertise, and familiarity with CSV validation and regulatory compliance requirements.
Key Responsibilities:
Business & Functional Responsibilities:
Collaborate with Manufacturing, Quality, Validation, and IT stakeholders to gather, analyze, and document business requirements.
Translate business requirements into MES functional specifications, solution designs, and implementation strategies.
Lead requirements workshops, discovery sessions, fit-gap analyses, design reviews, and user acceptance testing (UAT).
Partner with manufacturing teams to optimize production workflows and leverage POMS MES capabilities to improve operational performance.
Drive alignment between MES solutions, manufacturing processes, business objectives, and regulatory requirements.
Support process harmonization initiatives across manufacturing sites.
MES Technical Responsibilities:
Configure, support, and enhance POMS MES workflows, electronic batch records (EBR), recipes, and manufacturing execution processes.
Support MES module configuration, troubleshooting, and issue resolution activities.
Perform root cause analysis and corrective actions for production support issues.
Support and review MES integrations with enterprise systems such as ERP, LIMS, Historians, Automation/SCADA, and other manufacturing applications.
Review technical specifications, configuration documentation, and implementation deliverables.
Assist with system deployments, upgrades, migrations, and release management activities.
Provide expertise in electronic batch record execution, deviations management, manufacturing investigations, and exception handling.
Validation & Compliance Responsibilities:
Author, review, and maintain validation documentation including:
User Requirements Specifications (URS)
Functional Requirements Specifications (FRS)
Design Specifications (DS)
Installation Qualification (IQ)
Operational Qualification (OQ)
Performance Qualification (PQ)
Traceability Matrices
Validation Summary Reports (VSR)
Ensure compliance with:
FDA 21 CFR Part 11
GAMP 5 Guidelines
Good Manufacturing Practices (GMP)
ALCOA+ and Data Integrity requirements
Corporate Quality Management System procedures
Mandatory skills:
Bachelor's degree in Engineering, Computer Science, Information Technology, Life Sciences, or a related field.
8–12 years of experience in Life Sciences, Pharmaceutical, or Biotech manufacturing environments.
5+ years of hands-on experience supporting or implementing POMS MES solutions.
Strong understanding of MES concepts, electronic batch records (EBR), batch execution, manufacturing operations, and production workflows.
Experience working in GxP-regulated environments.
Solid understanding of pharmaceutical manufacturing processes, validation methodologies, and quality systems.
Experience supporting MES implementations, enhancements, upgrades, and production support activities.
Ability to review and interpret functional and technical documentation.
Strong troubleshooting and analytical problem-solving skills.
Optional skills:
Experience with large-scale MES implementation or site rollout programs.
Exposure to system integrations involving ERP, LIMS, Historian, SCADA, or automation platforms.
Knowledge of ISA-95 manufacturing standards and digital manufacturing architectures.
Experience supporting global manufacturing organizations.
Familiarity with Agile and hybrid project delivery methodologies
The pay range that the employer in good faith reasonably expects to pay for this position is $46.23/hour - $72.23/hour. Our benefits include medical, dental, vision and retirement benefits. Applications will be accepted on an ongoing basis.
Tundra Technical Solutions is among North America’s leading providers of Staffing and Consulting Services. Our success and our clients’ success are built on a foundation of service excellence. We are an equal opportunity employer, and we do not discriminate on the basis of race, religion, color, national origin, sex, sexual orientation, age, veteran status, disability, genetic information, or other applicable legally protected characteristic. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law, including the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. Unincorporated LA County workers: we reasonably believe that criminal history may have a direct, adverse and negative relationship with the following job duties, potentially resulting in the withdrawal of a conditional offer of employment: client provided property, including hardware (both of which may include data) entrusted to you from theft, loss or damage; return all portable client computer hardware in your possession (including the data contained therein) upon completion of the assignment, and; maintain the confidentiality of client proprietary, confidential, or non-public information. In addition, job duties require access to secure and protected client information technology systems and related data security obligations.
