PAS-X GMBR Developer / Designer

Requirements for each candidate. Please note we require a video screen, 2 professional references (managers, not co-workers) and photo identification.

1. Legal First Name:
2. Legal Last Name:
3. Date of Birth (MMDD):
4. Primary Phone Number:
5. LinkedIn Profile:
6. Email Address:
7. Current complete Address:
8. Visa / Work Authorization:
9. Current Pay Rate / Target Pay Rate:
10. Any Pending Interviews (or) Offers:
11. Willing to Relocate on Own Expenses: (Yes/No)
12. Any Planned Vacations:
13. When can the candidate video interview with me? PLEASE INCLUDE THEIR AVAILABILITY TO VIDEO SCREEN WITH ME
14. Photo Identification - Driver license or Passport
15. Professional References (provide 2 client references) - I will need company name, manager name, phone number and email address. THE REFERENCES NEED TO BE MANAGERS, not co-workers. * Interview Process: Two rounds of interviews., Planet Pharma is seeking an experienced PAS-X GMBR Developer / Designer to support a major Manufacturing Execution System (MES) initiative at a leading pharmaceutical manufacturing facility in Durham, NC. This individual will be responsible for the design, development, configuration, deployment, and ongoing support of Generic Master Batch Records (GMBRs) within the Werum PAS-X MES environment. The ideal candidate will have hands-on experience developing electronic batch records, supporting GMP manufacturing operations, providing production support, and configuring MES-connected shop floor devices including printers, scales, scanners, and operator terminals.

Responsibilities

• Design, develop, configure, test, and deploy Generic Master Batch Records (GMBRs) within the Werum PAS-X MES platform.
• Translate manufacturing process requirements into PAS-X electronic batch record solutions.
• Collaborate with Manufacturing, MS&T, QA, Validation, Automation, and IT teams to gather requirements and implement MES solutions.
• Configure workflows, process instructions, data collection forms, and exception handling within PAS-X.
• Provide day-to-day production support for the PAS-X MES environment, including troubleshooting batch execution issues and resolving manufacturing system incidents.
• Support manufacturing operations during batch execution and work directly with end users to resolve MES-related issues.
• Configure and support PAS-X interfaces with printers, barcode scanners, weigh scales, terminals, and other shop floor devices.
• Troubleshoot hardware, connectivity, and communication issues involving MES-integrated equipment and peripherals.
• Support integration between PAS-X, automation systems, manufacturing equipment, and other site applications.
• Troubleshoot, optimize, and enhance existing batch records and MES workflows.
• Author and review functional specifications, configuration documents, and technical documentation.
• Support validation activities including IQ/OQ/PQ, UAT, and system testing.
• Participate in deviation investigations, root cause analysis, CAPAs, and change control activities.
• Ensure compliance with GMP regulations, GAMP 5 guidelines, ALCOA+ principles, and 21 CFR Part 11 requirements.
• Support system deployments, go-live activities, and post-implementation stabilization efforts.

• 5+ years of experience supporting Werum PAS-X MES in a pharmaceutical or biotechnology environment.
• Proven experience developing and configuring GMBRs/electronic batch records within PAS-X.
• Hands-on experience providing production support in a live manufacturing environment.
• Experience configuring and supporting printers, barcode scanners, weigh scales, terminals, and other MES-connected shop floor devices.
• Strong understanding of pharmaceutical or biotechnology manufacturing processes.
• Experience working in GMP-regulated environments.
• Working knowledge of computerized system validation (CSV) and system lifecycle requirements.
• Familiarity with GAMP 5, data integrity requirements, and 21 CFR Part 11.
• Experience supporting MES integrations with manufacturing equipment and site systems.
• Strong troubleshooting, documentation, communication, and problem-solving skills.
• Ability to work effectively in a cross-functional project environment., * Experience supporting PAS-X implementations, upgrades, or site expansions.
• Experience with PAS-X V3 and/or PAS-X 3.3.
• Familiarity with SAP, DeltaV, PI Historian, LIMS, or other manufacturing systems.
• Experience supporting biologics, vaccines, sterile manufacturing, or large-scale pharmaceutical operations.
• Experience integrating legacy manufacturing equipment with PAS-X.
• Previous experience supporting MES systems on the manufacturing floor during commercial production.

InterSources Inc, a Certified Diverse Supplier, was founded in 2007 and offers innovative solutions to help clients with Digital Transformations across various domains and industries. Our history spans over 19 years and today we are an Award-Winning Global Software Consultancy solving complex problems with technology. We recognize that our employees and our clients are our strengths as the diverse talents and opportunities they bring to the table enable us to grow as a global platform and they are causally linked with our success. We provide strategic and technical advice, and we have expertise in areas covering Artificial Intelligence, Cloud Migration, Custom Software Development, Data Analytics Infrastructure & Cloud Solutions, Cyber Security Services, etc. We make reasonable accommodations for clients and employees and we do not discriminate based on any protected attribute including race, religion, color, national origin, gender sexual orientation, gender identity, age, or marital status. We also are a Google Cloud partner company. We align strategy with execution and provide secure service solutions by developing and using the latest technologies that thrive our resources to deliver industry-leading capabilities to our clients and customers, making it convenient for our clients to do business with InterSources Inc. Our teams also drive growth by refining technology-driven client experiences that put the users first, providing an unparalleled experience. This results in strengthening the core technologies of clients, enabling them to scale with flexibility, create seamless digital experiences and build lifelong relationships.