POMS Techno functional SME

Experienced POMS MES Techno-Functional SME with strong expertise in Manufacturing Execution Systems (MES) within a GxP-regulated pharmaceutical environment. The candidate will act as a bridge between business stakeholders, manufacturing operations, quality teams, and technical delivery teams to support, enhance, configure, and implement POMS MES solutions across manufacturing sites.

Key Responsibilities:

• Gather and analyze business requirements from Manufacturing, Quality, Validation, and IT stakeholders.

• Translate business requirements into MES functional specifications and system designs.

• Configure and support POMS MES workflows, electronic batch records (EBR), recipes, and manufacturing processes.

• Facilitate requirement workshops, fit-gap analyses, solution design reviews, and UAT sessions.

• Collaborate with manufacturing teams to optimize production processes through MES capabilities.

• Ensure MES solutions align with business processes, GMP requirements, and regulatory expectations.
  

Technical Responsibilities:

• Configure and support POMS MES modules and integrations.

• Troubleshoot MES production issues and perform root cause analysis.

• Support interface development and integration with:

• Review technical specifications, configuration documents, and implementation deliverables.

• Support deployment, migration, and system upgrades.

• Knowledge of electronic batch records (EBR), batch execution, deviations, and manufacturing investigations.
  

GxP & Validation Responsibilities:

• Support CSV (Computer System Validation) activities.

Author and review:

• URS

• FRS

• Design Specifications

• IQ/OQ/PQ Protocols

• Traceability Matrix

• Validation Summary Reports

Ensure compliance with:

• FDA 21 CFR Part 11

• GAMP 5

• GMP requirements

• Data Integrity guidelines

Desired Soft Skills:

• Strong stakeholder management.

• Excellent communication and documentation skills.

• Ability to work with cross-functional global teams.

• Strong analytical and problem-solving abilities.

• Leadership in driving workshops, solution reviews, and issue resolution.

Mandatory skills:

• Experienced POMS MES Techno-Functional SME with strong expertise in Manufacturing Execution Systems (MES) within a GxP-regulated pharmaceutical environment. The candidate will act as a bridge between business stakeholders, manufacturing operations, quality teams, and technical delivery teams to support, enhance, configure, and implement POMS MES solutions across manufacturing sites.

The pay range that the employer in good faith reasonably expects to pay for this position is $50.85/hour - $79.46/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.

Salary : $51 - $79