MES Practice Leader - Werum PAS-X

Life Sciences MES Practice Lead (Werum PAS‑X)

Role Overview

This role is responsible for building and scaling an organic Life Sciences MES capability with a strong focus on Werum PAS‑X. The position is designed for a senior leader who can establish a new MES practice from the ground up, beginning with initial talent acquisition and scaling into a high-performing team and standalone "mini business."

The successful candidate will lead MES technical delivery, define best practices, support client growth, and take ownership of developing a sustainable PAS‑X‑focused MES offering within a broader engineering and technology organization.

This is a highly entrepreneurial role combining deep MES domain expertise, people leadership, and commercial accountability within regulated life sciences manufacturing environments.

Key Responsibilities

Practice & Team Development

• Build and scale an organic Life Sciences MES capability centered on Werum PAS‑X, starting with initial hires and expanding into a dedicated delivery team.
• Recruit, mentor, and develop MES engineers and solution architects, establishing standards for quality, delivery, validation, and utilization.
• Define and implement scalable MES delivery models, including configuration standards, data models, templates, and deployment methodologies to accelerate execution.
• Serve as the senior technical authority for PAS‑X‑based MES implementations within regulated manufacturing environments.

Technical & Delivery Leadership

• Lead complex life sciences MES projects, including greenfield implementations, brownfield integrations, global template rollouts, and major PAS‑X upgrades.
• Provide subject matter expertise in MES architecture, PAS‑X core modules, electronic batch records (EBR), recipe management, master data modeling, and manufacturing workflows.
• Oversee the full MES project lifecycle: requirements gathering, functional design, configuration, testing, deployment, validation, and production support.
• Partner closely with automation, IT, quality, and manufacturing teams to integrate MES with control systems, historians, LIMS, ERP, and data platforms.
• Support validation activities across the MES lifecycle, including CSV strategy, risk assessments, and execution of IQ/OQ/PQ where applicable.

Client Engagement & Growth

• Act as a trusted advisor to client stakeholders across Manufacturing, Engineering, Quality, IT, and global MES governance teams.
• Support pre‑sales efforts, including MES solution strategy, level‑of‑effort development, scope definition, and technical presentations.
• Help expand client relationships from initial MES implementations into multi‑site rollouts, long‑term support models, and digital manufacturing programs.

Commercial & Entrepreneurial Ownership

• Take accountability for MES practice performance, including delivery quality, margins, utilization, and overall practice health.
• Contribute to scoping, statements of work, pricing awareness, delivery risk management, and change control processes.
• Operate with an ownership mindset, comfortable building capability from a low base and scaling responsibly over time.

Required Experience & Background

Core Experience

• 10-15+ years of experience in life sciences manufacturing environments, including biologics, sterile/aseptic, vaccines, or high‑potency facilities, with strong GMP experience.
• 8-10+ years of hands‑on MES experience within pharma or biotech, with significant exposure to Werum PAS‑X implementations.
• Recent experience leading complex MES deliveries, including greenfield PAS‑X deployments, brownfield MES integrations, or enterprise‑level template rollouts.

Leadership & Prior Roles

• Previous roles may include MES Lead, PAS‑X Architect, Digital Manufacturing Lead, Automation & MES Manager, Senior Manager, or Associate Director within a pharmaceutical manufacturer, CDMO, or life sciences‑focused system integrator.
• Demonstrated experience managing technical teams and external vendors, including performance management and professional development.
• Proven ability to hire, develop, and scale high‑quality MES delivery teams and define best practices for billable MES resources.

Technical Expertise

• Deep understanding of PAS‑X architecture, EBR design, master data modeling, and MES deployment strategies in regulated environments.
• Strong knowledge of CSV expectations, FDA and EU GMP requirements, and risk‑based validation approaches for MES systems.
• Familiarity with the broader digital manufacturing ecosystem, including automation platforms, historians, ERP integrations, and data solutions.

Desired Attributes

• Maintains a strong professional network of MES and PAS‑X engineers, solution architects, and digital manufacturing SMEs that can be leveraged to build a team within 6-12 months.
• Comfortable creating MES standards, templates, and delivery frameworks that enable rapid onboarding and productivity of junior engineers.
• Strong communicator who can engage effectively with both highly technical teams and non‑technical business stakeholders.
• Naturally entrepreneurial, motivated by building teams, capabilities, and long‑term value within life sciences manufacturing.

Location

• US‑based, preferably located in or near a major life sciences hub such as Boston/Cambridge, NYC/Northern NJ, Philadelphia, RTP, the Bay Area, Chicago, or the MD/DC corridor.