UST
Website:
ussmokeless.com
Company:
https://www.linkedin.com/company/ustglobal
Seniority: Not Applicable
Industries: IT Services and IT Consulting
Job details:
Role Description
Recipe Author
Who We Are
At UST, we help the world’s best organizations grow and succeed through transformation. Bringing together the right talent, tools, and ideas, we work with our client to co-create lasting change. Together, with over 30,000 employees in 30+ countries, we build for boundless impact—touching billions of lives in the process. Visit us at .
Summary
UST is looking for Recipe Author –
Recipe Author Description Design, configuration, and rollout of ROCKWELL FTPS for pharmaceutical clients. Prepare and review Recipes and workflows such as cleaning worksheets and calibration records. Conduct mock MBR executions, validate design logic, and ensure readiness for production. Review executed eBRs and provide technical support for validation and troubleshooting. Drive digitalization initiatives, converting manual process documents into PAS-X MES workflows. Deliver operator training sessions on ROCKWELL FTPS functionality and ensure GxP compliance. Collaborate with QA, IT, and production teams to standardize MES operations. End-to-end MBR (Master Batch Record) verification activities within ROCKWELL FTPS, ensuring accuracy, completeness, and regulatory compliance. Review and approve electronic MBR designs against approved paper batch records, process flow diagrams, and control strategies. Define and executed MBR verification strategies, including challenge testing, boundary condition checks, and exception handling. Ensure MBR alignment with global MES templates, site-specific requirements, and standard design principles. Cordiant cross-functional reviews with MBR designers, MES SMEs, QA, manufacturing, and validation teams. Identify and resolve MBR defects, data integrity gaps, and workflow inconsistencies prior to validation and release. Author and maintain MBR verification protocols, checklists, and summary reports. Support UAT, OQ, and PQ phases by providing verified and compliant MBR content. Mentore junior reviewers and established best practices for MBR lifecycle management. Ensure readiness for regulatory inspections and audits through robust documentation and traceability.
Skill
- Design and configure MES recipes using Rockwell PharmaSuite or comparable systems.
- Translate process requirements into scalable, validated electronic batch records.
- Partner with manufacturing, quality, and engineering teams to enhance efficiency and compliance.
- Maintain documentation and configuration logs aligned with GxP and FDA 21 CFR Part 11.
- Lead recipe optimization initiatives that improve standardization and audit readiness.
- Deliver practical training and support to increase user adoption and system maturity.
What We Believe
We’re proud to embrace the same values that have shaped UST since the beginning. Since day one, we’ve been building enduring relationships and a culture of integrity. And today, it's those same values that are inspiring us to encourage innovation from everyone to champion diversity and inclusion and to place people at the centre of everything we do.
Humility
We will listen, learn, be empathetic and help selflessly in our interactions with everyone.
Humanity
Through business, we will better the lives of those less fortunate than ourselves.
Integrity
We honour our commitments and act with responsibility in all our relationships.
Equal Employment Opportunity Statement
UST is an Equal Opportunity Employer. We believe that no one should be discriminated against because of their differences, such as age, disability, ethnicity, gender, gender identity and expression, religion, or sexual orientation.
All employment decisions shall be made without regard to age, race, creed, colour, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status or any other basis as protected by federal, state, or local law.
UST reserves the right to periodically redefine your roles and responsibilities based on the requirements of the organization and/or your performance.
- To support and promote the values of UST.
- Comply with all Company policies and procedures
Skills
Rockwell PharmaSuite, PAS-X MES, FDA 21 CFR Part 11, GxP
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