MES Lead

Job Title: MES Lead

Location: Onsite – North Carolina Job Type: Contract

Job Overview:

Our client is seeking an experienced MES Lead to support a scope expansion initiative for a new manufacturing client. This is an onsite role based in North Carolina , focused on leading the end-to-end implementation of Manufacturing Execution Systems (MES) across diverse pharmaceutical processes.

Key Responsibilities:

Lead the MES implementation across key manufacturing areas such as:

Filling , Compounding , Formulation

Oral Solid Dosage (OSD) , Fractionation , Purification

Act as the primary driver of the MES project from initiation through completion.

Design MES solutions without a pre-defined blueprint—adapt and build as the project evolves.

Translate process needs and technical specifications into detailed User Requirements Specifications (URS) .

Collaborate with cross-functional teams including automation, validation, IT, and production.

Interface with stakeholders to ensure alignment on project goals and deliverables.

Assist in transitioning Rockwell-based automation knowledge into comprehensive URS documentation.

Ensure system compliance and support validation efforts as needed.

Requirements

• 8–10+ years of MES project leadership experience in a pharma/biotech manufacturing environment.

• Proven success in implementing MES systems from scratch or through major scope expansions.

• Strong understanding of manufacturing processes including formulation, OSD, and biologics.

• Experience writing and managing User Requirements Specifications (URS) .

• Familiarity with Rockwell systems and their integration into MES workflows.

• Validation experience is highly preferred.

• Ability to work independently, problem-solve, and manage ambiguity in evolving project scopes.

Preferred Qualifications

• Prior experience in greenfield or brownfield MES deployments.

• Knowledge of compliance and regulatory standards in pharma manufacturing (e.g., 21 CFR Part 11, GAMP).

• Experience interfacing with vendors and third-party solution providers.