Manufacturing Execution System (MES) Specialist 1

Fujifilm•Holly Springs, NC

1d•Onsite

About The Position

Make medicines better, faster, and more reliably. Join us as an MES Specialist I and own the end‑to‑end design, configuration, testing, and lifecycle support of electronic Master Batch Records (eMBRs) in Werum PAS‑X. You will translate manufacturing science into digital workflows that run our drug product operations—driving right‑first‑time execution, data integrity, and compliant performance.

Requirements

High School Diploma or equivalent with 6+ years of applicable industry experience; OR Bachelor’s degree in Pharmaceutical Sciences, Biotechnology, Microbiology, or a closely related field with 2+ years of applicable industry experience; OR Master’s degree with no previous experience; OR Equivalent military experience or training.
Experience in drug product manufacturing, sterile processing, or quality assurance.
Strong proficiency with PAS‑X Master Batch Record design tools and configuration libraries.
In‑depth knowledge of current Good Manufacturing Practice regulations and electronic records/electronic signatures compliance.
Working knowledge of drug product unit operations (formulation, aseptic filling, lyophilization, inspection, packaging).
Ability to identify, quantify, and implement continuous improvements that reduce exceptions and downtime and improve right‑first‑time performance.
Clear, organized documentation skills, including configuration specs, workflow diagrams, and decision records for audit readiness and knowledge transfer.
Mentorship mindset to guide junior team members on configuration practices, testing methods, and compliance expectations; strong reviewer of work products for consistency and quality.
Proven project and time management: plan work, set priorities, meet timelines, and deliver results while maintaining compliance rigor.

Nice To Haves

Bachelor’s degree in Engineering, Computer Science, Life Sciences, or related field.
2+ years of experience in pharmaceutical manufacturing or MES (preferably PAS‑X).
Strong understanding of drug product processes such as formulation, filling, lyophilization, inspection, and packaging.
Proficiency with PAS‑X Master Batch Record design tools and configuration libraries.
Training or certification Preferred: Bioworks certificate

Responsibilities

Design, configure, and maintain Master Batch Records in PAS‑X aligned to defined manufacturing processes and regulatory requirements.
Execute and document system testing and computer system validation deliverables to meet 21 Code of Federal Regulations Part 11, European Union Annex 11, and data integrity expectations.
Define and manage batch components in the system, including materials, equipment, parameter sets, interlocks, electronic signatures, and workflow logic to ensure accurate and reliable execution.
Gather user requirements with Manufacturing, Quality Assurance, Process Engineering, Validation, and Information Technology and translate them into functional digital workflows and clear acceptance criteria.
Provide on‑floor support during batch execution; troubleshoot electronic Master Batch Record performance and PAS‑X functionality; implement timely fixes to maintain production continuity.
Lead and contribute to continuous improvement initiatives that enhance electronic Master Batch Record design, reduce execution exceptions and downtime, and improve right‑first‑time performance.
Participate in and, when appropriate, lead change control activities, deviation investigations, and impact assessments related to MES and eMBR updates.
Maintain alignment with regulatory compliance and quality standards in all electronic documentation and configurations.
Perform other duties, as assigned, to support reliable, compliant manufacturing.