Job Description
Our client, a IT Services and Consulting company, is looking for a Senior PAS-X MES MBR Author / MES Business Analyst for their Lithia Springs, GA/Hybrid location.
Responsibilities:
Requirements:
Why Should You Apply?
Responsibilities:
- The Senior MES MBR Author & Coordinator is responsible for authoring, reviewing, and coordinating end-to-end execution of electronic Master Batch Records (eMBRs) in PAS-X for GMP manufacturing. This role partners closely with Manufacturing, Process Engineering, Quality, Validation/CSV, and IT/MES to ensure batch records are accurate, compliant, production-ready, and supported during shop-floor execution
- Author, configure, and maintain PAS-X eMBRs/master recipes, including process steps, equipment phases, material consumption, data collection, prompts, checks, and electronic signatures.
- Translate process descriptions, and manufacturing instructions into robust, right-first-time PAS-X implementations.
- Build in error-proofing (constraints, limits, conditional logic, dependencies) to reduce deviations and support ALCOA+ data integrity.
- Maintain master data elements tied to records (materials, BOM/consumables usage, equipment/units, process parameters, sample points), as required for record execution.
- Coordinate cross-functional review cycles (Manufacturing, QA, MSAT, Validation, Automation/IT) and drive to timely approvals.
- Manage master record versioning, traceability, and controlled release in alignment with site change control and document management practices.
- Ensure eMBR design and changes meet GMP and site data integrity requirements
- Provide on-site, hands-on support for manufacturing execution, including End User training and resolving issues related to PAS-X master records (runtime errors, missing master data, step logic issues, signature/role issues).
- Support deviation investigations by providing execution trace analysis (where appropriate), master record logic review, and corrective actions to prevent recurrence.
- Support planned/critical manufacturing campaigns, including floor presence during start-up, recipe cutovers, and high-risk steps.
Requirements:
- PASX (Werum / Koerber) MBR Design and Operational Support
- Life Sciences industry understanding of GMP concepts: data integrity (ALCOA+), electronic signatures, validation requirements, audit trails, controlled documents, deviations/CAPA, and change control
- Strong Communication and Interpersonal skills to collaborate with diverse stakeholders and drive decisions
- Experience with sterile manufacturing, biologics, cell therapy, or fill-finish operations.
- Exposure to interfaces/integration concepts (ERP/LIMS/SCADA), ISA-88/ISA-95, and master data governance.
- Experience supporting or authoring validation deliverables (URS/FS/DS, IQ/OQ/PQ) for MES changes.
- Years of Experience: 12.00 Years of Experience
Why Should You Apply?
- Health Benefits
- Referral Program
- Excellent growth and advancement opportunities
Numbers & Facts
| Location | Lithia Springs, GA |
| Industry | Management Consulting Services |
| Salary | $60.71 Per Hour |
| Company Size | 2,000 to 2,499 employees |
| Year Founded | 2000 |
| Website | https://www.iconma.com/ |
Benefits
401K, Employee Referral Program, Life Insurance
About Company
ICONMA is a global information consulting management firm providing Professional Staffing Services and Project-Based Solutions for organizations in a broad range of industries.
- Corporate Headquarters in Troy, Michigan; 20+ locations worldwide.
- Certified Woman-Owned Business Enterprise (WBE); certified by Women’s Business Enterprise National Council, National Women Business Owners Corporation (NWBOC); and California Public Utilities Commission (CPUC).
- Founded in 2000
- 2000+ Employees
The company was founded on the principle that success is derived from delivering high quality service and resources in the most responsive, flexible, and innovative way. ICONMA invests in people and resources with a single goal: To provide our customers with the highest quality service in the most responsive manner. Through its network of offices, ICONMA provides the resources to help clients maintain their competitive advantage.
Skills
- Analysis Skillsunmatched
- Automationunmatched
- Bill of Materials (BOM)unmatched
- Biologyunmatched
- Business Analysisunmatched
- Business Writingunmatched
- Campaignsunmatched
- Cell Biologyunmatched
- Change Controlunmatched
- Communication Skillsunmatched
- Corrective Actionunmatched
- Corrective and Preventative Action (CAPA) Systemsunmatched
- Cross-Functionalunmatched
- Data Collectionunmatched
- Data Qualityunmatched
- Document Change Managementunmatched
- Document Managementunmatched
- ERP (Enterprise Resource Planning)unmatched
- GMP (Good Manufacturing Practices)unmatched
- Health Planunmatched
- ISA Standardsunmatched
- Information Technology Consultingunmatched
- Interpersonal Skillsunmatched
- Laboratory Information Management System (LIMS)unmatched
- Manufacturingunmatched
- Manufacturing Process Engineeringunmatched
- Operational Supportunmatched
- Organizational Skillsunmatched
- Process Manufacturingunmatched
- Process Validationunmatched
- Proofreadingunmatched
- Quality Assuranceunmatched
- Requirements Validation/Verificationunmatched
- Resolve Customer Issuesunmatched
- Riskunmatched
- Startupunmatched
- Supervisory Control and Data Acquisition (SCADA)unmatched
- Team Playerunmatched
- Time Managementunmatched
- Traceabilityunmatched
- Writing Skillsunmatched
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