MES engineer (PAS-X Expert)

Position: Senior Digital Engineer – PAS-X Expert

Location: Athens, Ohio (Onsite)

Experience: 10+ Years

Industry: Pharmaceutical / Life Sciences

About the Role

We are seeking a Senior Digital Engineer with strong expertise in Werum PAS-X (MES) to lead automation initiatives within a highly regulated pharmaceutical manufacturing environment.

This is a hands-on, leadership role where you will drive end-to-end implementation, ensure compliance, and optimize production systems for performance and reliability.

Key Responsibilities

·         Lead design, configuration, and implementation of Werum PAS-X systems

·         Manage MES integration with manufacturing and enterprise systems

·         Drive automation projects from planning through execution

·         Ensure compliance with GMP, FDA, and 21 CFR Part 11 regulations

·         Oversee validation activities (IQ/OQ/PQ) and system qualification

·         Perform system troubleshooting, maintenance, and optimization

·         Develop and maintain SOPs, validation documents, and change controls

·         Provide training and technical guidance to internal teams

·         Identify and implement continuous improvement opportunities

Required Skills

·         10+ years of experience in pharmaceutical/biotech automation

·         Strong hands-on expertise in Werum PAS-X (MES)

·         Deep knowledge of GMP, FDA regulations, and compliance frameworks

·         Experience with system validation (IQ/OQ/PQ)

·         Proven project leadership and delivery experience

·         Strong problem-solving and analytical skills

·         Excellent communication and documentation abilities

Preferred Qualifications

·         Experience with Electronic Batch Records (EBR)

·         Exposure to MES integration with ERP/SCADA/PLC systems

·         Background in digital manufacturing or Industry 4.0 initiatives

What We’re Looking For

·         A subject matter expert in PAS-X who can lead from the front

·         Someone comfortable in a hands-on + leadership hybrid role

·         Experience working in regulated manufacturing environments

·         Ability to drive efficiency, compliance, and system reliability

Apply Now

If you are a seasoned PAS-X professional looking to take ownership of impactful automation projects, we’d love to connect with you!