US_East | Manufacturing & Process Engineer_L4

Datum Software, Inc

Albany, NY

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JOB DETAILS

SKILLS

Acceptance Testing, Agile Programming Methodologies, Analysis Skills, Automation, Biology, Biotech and Pharmaceutical, Business Analysis, Code of Federal Regulations, Computer Science, Computer Skills, Computer Systems, Corrective Action, Data Quality, Documentation, Drug Manufacturing, ERP (Enterprise Resource Planning), Enterprise Application Integration (EAI), Environmental Sciences, Error Handling, FDA (Food and Drug Administration), GMP (Good Manufacturing Practices), Gap Analysis, GxP, ISA Standards, Identify Issues, Information Technology & Information Systems, Laboratory Information Management System (LIMS), Leadership, Maintain Compliance, Manufacturing, Manufacturing Execution Systems (MES), Manufacturing Operations, Manufacturing Process Engineering, Manufacturing Software, Manufacturing/Industrial Processes, Problem Solving Skills, Process Validation, Production Support, Quality Management, Regulatory Compliance, Regulatory Requirements, Release Management/Engineering, Requirements Management, Root Cause Analysis, Supervisory Control and Data Acquisition (SCADA), System Lifecycle, System Validation, Technical Support, Technical Writing, Testing, Traceability, Validation Documentation, Writing Skills

LOCATION

Albany, NY

POSTED

5 days ago

Role: Digital Engineer – POMS MES
Location: Albany, NY (Preferred)

Top 5 Required Skills

5+ years of hands-on experience with POMS MES implementation and support
Strong knowledge of Manufacturing Execution Systems (MES) and Electronic Batch Records (EBR)
Experience working in GxP-regulated pharmaceutical or life sciences environments
Expertise in Computer System Validation (CSV) and FDA compliance (21 CFR Part 11, GAMP 5)
Strong techno-functional experience with MES integrations, manufacturing workflows, and production support

Job Description
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 act as the liaison between business stakeholders, manufacturing operations, quality, validation, and technical teams to support, enhance, configure, and implement POMS MES solutions across manufacturing sites.
This role requires strong functional knowledge of pharmaceutical manufacturing processes, hands-on POMS MES expertise, and experience with Computer System Validation (CSV) and regulatory compliance.

Key Responsibilities:
Business & Functional Responsibilities

Collaborate with Manufacturing, Quality, Validation, and IT teams to gather, analyze, and document business requirements.
Translate business requirements into 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 using POMS MES capabilities.
Align MES solutions with manufacturing processes, business objectives, and regulatory requirements.
Support process standardization and harmonization initiatives across manufacturing sites.

MES Technical Responsibilities

Configure, support, and enhance POMS MES workflows, Electronic Batch Records (EBRs), recipes, and manufacturing execution processes.
Perform MES configuration, troubleshooting, and issue resolution.
Conduct root cause analysis and implement corrective actions for production issues.
Support integrations with enterprise applications including:
- ERP
- LIMS
- Historians
- SCADA/Automation systems
- Other manufacturing applications
Review technical specifications, configuration documentation, and implementation deliverables.
Support deployments, upgrades, migrations, and release management activities.
Provide expertise in:
- Electronic Batch Record execution
- Deviation management
- Manufacturing investigations
- Exception handling

Validation & Compliance Responsibilities

Support Computer System Validation (CSV) activities throughout the system lifecycle.
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+ Data Integrity principles
- Corporate Quality Management System procedures

Required Qualifications:

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:
- Manufacturing Execution Systems (MES)
- Electronic Batch Records (EBR)
- Batch execution
- Manufacturing operations
- Production workflows
Experience working in GxP-regulated environments.
Solid knowledge of pharmaceutical manufacturing processes, validation methodologies, and quality systems.
Experience supporting MES implementations, enhancements, upgrades, and production support.
Ability to review and interpret functional and technical documentation.
Excellent analytical, troubleshooting, and problem-solving skills.

Preferred Qualifications:

Experience leading large-scale MES implementations or multi-site rollouts.
Experience integrating MES with ERP, LIMS, Historians, 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.

“All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran”

About the Company

Datum Software, Inc

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