What are the responsibilities and job description for the Technical Lead-MES position at Adbakx?
Job Title: MES Technical Lead
Location: Hybrid at Greenville, NC (Locals preferred)
Position Type: Contract
NOTE: PharmaSuite experience is a must
Description:
The ideal candidates must meet the following qualifications:
• Over 10-15 years of experience in MES/Automation execution within the pharmaceutical manufacturing industry.
• Expertise in GMP requirements and compliance for complex MES solutions.
• In-depth knowledge of pharma manufacturing processes including filling, compounding, formulation, OSD, fractionation, purification, etc.
• Ability to translate manufacturing processes into MES solutions across various ISA-95 layers, ensuring proper data modeling and defining sources of truth.
• Proven experience with MES/Control systems integration (e.g., DeltaV, FactoryTalk, DCS, etc.).
• In-depth understanding of SAP order management, inventory, and materials management modules, with a focus on MES integration.
• Extensive experience in the design and implementation of MES software (e.g., Syncade, PharmaSuite, PMX, PAS-X).
• Proficient in reviewing and troubleshooting recipes, making necessary updates to meet client specifications.
• Familiarity with validation tools such as Kneat and HP ALM.
• Proven experience in developing MES validation strategies, test scripts, and execution plans.
• Track record of delivering MES training across all levels of the organization (e.g., operators, supervisors, quality teams).
• Ability to prioritize and work under aggressive schedules.
Additional responsibilities will include:
• Willingness to perform on-site visits at short notice, including peripheral equipment integration support, recipe dry runs, execution, and deployment.
• Providing technical direction for MES and integration design, development, and validation activities.
• Ensuring adherence to global standards, including alignment with Thermo Fisher's MES and IT frameworks.
• Effectively articulating technical issues and solutions for escalation to project sponsors or leadership teams.
• Independently drafting, reviewing, and updating SDLC documentation (e.g., URS, Trace Matrix, Test Scripts, SOPs, Change Logs) with minimal supervision.
• Leading customer reviews and dry runs of solutions, acting as a liaison between site teams and Rockwell.
• Managing equipment configurations and connections, including peripherals like scales and workstations.
• Verifying IT configurations, such as ports and firewalls, to ensure seamless integration.
• Leading the creation and implementation of a site-wide training program across different functional teams.
