Senior Technical MES Lead – Pharma Suite

Intellectt Inc; North Carolina; On-site; USD 100,000 - 145,000; Full time

Job summary

A leading company in pharmaceutical manufacturing is looking for a Senior Technical MES Lead with expertise in Pharma Suite. The role involves leading the development of User Requirement Specifications, collaborating with vendors, and ensuring regulatory compliance in MES solutions to support pharmaceutical processes.

Qualifications

• 5+ years experience in MES implementation within pharmaceutical manufacturing.
• Strong knowledge of MES concepts, regulatory requirements.

Responsibilities

• Lead creation and management of User Requirement Specifications (URS) for MES projects.
• Collaborate with vendors to deliver MES solutions.
• Ensure compliance with regulatory guidelines.

Skills

Analytical Skills

Problem-Solving

Communication

Stakeholder Management

Education

Bachelor’s or Master’s degree in Engineering, Computer Science, Pharmaceutical Sciences

Job description

Senior Technical MES Lead – Pharma Suite

Senior Technical MES Lead – Pharma Suite

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Unicorn Recruiter | Tech & Business Talent Specialist | People-First Hiring Partner | Empowering Careers, Enabling Growth @ Intellectt Inc |…

Hello,

One of my clients is currently seeking a Senior Technical MES Lead – Pharma Suite. If this role aligns with your experience or interests, I’d love to connect with you. Please share your updated resume with me at [e-mail], or feel free to call me directly at [phone] to discuss further.

Job Title: Senior Technical MES Lead – Pharma Suite

Location: NC

Department: Manufacturing Execution Systems (MES) / IT / Engineering

Job Summary:

We are seeking an experienced Senior Technical MES Lead with strong expertise in Pharma Suite to lead the development and implementation of User Requirement Specifications (URS) in collaboration with external vendors. The ideal candidate will have deep knowledge of Manufacturing Execution Systems within the pharmaceutical industry, ensuring compliance with regulatory standards and alignment with business needs.

Key Responsibilities:

• Lead the creation, review, and management of User Requirement Specifications (URS) for MES Pharma Suite projects.
• Collaborate closely with vendors to define technical and functional requirements and ensure successful delivery of MES solutions.
• Act as the primary liaison between business stakeholders, IT teams, and vendors to translate business needs into technical requirements.
• Drive MES system design, customization, and configuration to support pharmaceutical manufacturing processes.
• Ensure all MES solutions comply with cGMP, FDA, EMA, and other relevant regulatory guidelines.
• Oversee validation activities related to MES implementations, including creating validation documentation and coordinating validation testing.
• Provide technical leadership and guidance to the MES team and project stakeholders.
• Troubleshoot and resolve MES-related technical issues during development, testing, and post-deployment phases.
• Manage project timelines, deliverables, and vendor performance to ensure project milestones are met.
• Stay updated on MES technology trends, industry best practices, and regulatory changes relevant to pharma manufacturing.

Qualifications & Skills:

• Bachelor’s or Master’s degree in Engineering, Computer Science, Pharmaceutical Sciences, or related field.
• Proven experience (5+ years) in MES implementation within pharmaceutical manufacturing, preferably with Pharma Suite.
• Strong knowledge of MES concepts, pharmaceutical manufacturing processes, and regulatory requirements (21 CFR Part 11, GAMP5).
• Experience developing and managing URS documentation and working with vendors on MES projects.
• Familiarity with software development lifecycle (SDLC) and validation methodologies in pharma environments.
• Excellent communication and stakeholder management skills.
• Strong analytical, problem-solving, and organizational abilities.
• Experience in project management and vendor coordination.
• Knowledge of related systems (ERP, SCADA, LIMS) is a plus.

Preferred:

• Certification in MES, Project Management (PMP), or related fields.
• Hands-on experience with specific Pharma Suite modules and integrations.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Industries

  Pharmaceutical Manufacturing, Medical Equipment Manufacturing, and Biotechnology Research

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