Position- MES Pharma Suite Support Engineer

Location- Concord, NC

Visa- No H1

Type- Hybrid- office 4 days/week

Job Description:

Theoris Services is assisting our client in their search for a MES Support Engineer to add to their growing team located in Concord, NC. Our client is seeking an individual to support, develop and/or deploy manufacturing execution systems and equipment to fulfill business needs. The ideal candidate will provide support for new and existing manufacturing applications, systems and equipment relying on candidate’s business area knowledge and computer skills. Solves existing system problems, analyzes information designs, programs and/or implements new systems or enhancements to existing systems in accordance with company standards and guidelines.

Responsibilities:

• Develop application knowledge and business context
• Be an expert and resource in the business use of the PharmaSuite Manufacturing Execution System (MES) application
• Accurately translate business processes, which may span multiple areas, into technical terms, and vice versa
• Leverage knowledge and communication of/with the business to create or update electronic execution tickets
• Build and maintain awareness and knowledge of regulatory, legal, or quality requirements impacting the business areas, and ensure that solution requirements comply
• Assist the Global next generation MES team and third parties in the validation of the MES System during the deployment of the application in the site
• Lead the delivery and support of digital solutions and electronic tickets from the site perspective
• Work with the business to identify and capture new opportunities, improve processes, and optimize the value IDS can provide
• Work with the business to define changes to our manufacturing process that have an impact into our electronic tickets and make the appropriate changes
• Effectively influence the business to drive value and to implement the appropriate digital solutions, and challenge different levels of the organization
• Produce and maintain local project and validation documentation
• Ensure systems remain in a validated state and manage their lifecycle through releases, recapitalization, and retirement
• Ensure the incident, problem, configuration, and change/release management are all accomplished in alignment with and understanding of business need

Requirements:

Technical Skills:

• Expertise in MES (e.g., PharmaSuite), programming, and system design.
• Ability to troubleshoot and enhance MES applications.

Business Process Translation:

• Translate manufacturing processes into technical requirements and vice versa.

Regulatory Knowledge:

• Understand regulatory, legal, and quality standards for manufacturing.
• Ensure MES solutions comply with standards.

Documentation & Validation:

• Create/maintain project and validation documentation.
• Manage system lifecycle (validation, releases, retirement).

Communication & Collaboration:

• Strong communication to collaborate with global teams and stakeholders.
• Influence and challenge to drive digital solutions.

Process Optimization:

• Identify and implement process improvements and digital solutions.
• Update electronic execution tickets based on process changes.

IT Service Management:

• Knowledge of incident, problem, configuration, and change/release management.

Analytical Skills:

• Analyze data and design solutions aligned with business goals.

Leadership & Teamwork:

• Lead/support MES deployment and validation.
• Work effectively in cross-functional/global teams.