What are the responsibilities and job description for the Technical MES Lead position at ARK Infotech Spectrum?
Job Details
Role: Sr Technical MES Lead
Location: Greenville, NC (Hybrid role, Locals preferred) - Candidate must travel to office on need basis.
Duration of project: 6 months
Job Summary:
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.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
