MES MBR Author

Job Title: MES MBR Author
Duration: 6-12 months
Location: Onsite Springs, GA




Work Type:
Rate: Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.




Skills :
1. PASX (Werum / Koerber) MBR Design and Operational Support
2. Life Sciences industry understanding of GMP concepts: data integrity (ALCOA+), electronic signatures, validation requirements, audit trails, controlled documents, deviations/CAPA, and change control
3. Strong Communication and Interpersonal skills to collaborate with diverse stakeholders and drive decisions

Additional Information:

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.

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.

ABOUT Ztek:
Website:
Ztek Consulting Inc is a minority- and woman-owned business enterprise that leverages a unique blend of human talent, machine learning algorithms, and artificial intelligence to provide customized talent management solutions for clients. Ztek's diversity-focused hiring models have proven successful, particularly in hiring veterans. The company's veteran-focused hiring and deployment program, Z-V.E.T, matches skilled veterans with clients' needs in various areas.
Disclaimer:
Ztek is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Ztek is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates.If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at View email address on us.fitly.work Please indicate the specifics of the assistance needed. Ztek encourages all interested and qualified candidates to apply for employment opportunities. Ztek does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. 1324b.