Digital Engineer – POMS MES

Are you passionate about leveraging cutting-edge digital solutions to transform the pharmaceutical manufacturing landscape? Do you thrive in environments where your expertise directly impacts operational excellence and patient safety? PDDN is actively searching for a seasoned Digital Engineer with specialized knowledge in POMS MES. This isn-t just another role; it's an opportunity to be a pivotal force in bridging critical business, quality, validation, and IT functions, ensuring our clients' GxP manufacturing processes are not only compliant but also at the forefront of innovation. If you-re ready to deploy your techno-functional skills to implement robust MES solutions and drive significant advancements in a fully remote, worldwide setting, then we invite you to explore this exciting challenge with us.

Overview

PDDN is seeking a highly skilled and experienced Digital Engineer specializing in POMS MES. This is a crucial techno-functional SME role designed for individuals who excel at configuring, supporting, and implementing Manufacturing Execution System (MES) solutions within pharmaceutical manufacturing environments. You will be instrumental in ensuring GxP compliance and driving operational efficiency for our clients. This is a fully remote W2 opportunity, offering immediate starts for qualified candidates.

Key Responsibilities

Act as a POMS MES techno-functional subject matter expert, guiding clients through complex implementation and support phases.
Bridge the gap between business requirements, quality standards, validation protocols, and IT solutions within pharma manufacturing.
Configure and optimize POMS MES solutions to meet specific GxP and operational needs.
Provide comprehensive support and troubleshooting for existing MES systems, ensuring minimal downtime and maximum efficiency.
Lead or contribute significantly to Computer System Validation (CSV) efforts, adhering to strict regulatory guidelines like FDA 21 CFR Part 11 and GAMP 5.
Develop and maintain thorough documentation for MES configurations, processes, and support procedures.
Ensure continuous compliance with regulatory standards and industry best practices.
Collaborate effectively with diverse teams including manufacturing, quality assurance, IT, and validation personnel.

Requirements

Experience: A solid 8-12 years in the Pharmaceutical or Life Sciences industry, with a minimum of 5 years specifically focused on POMS MES.
Technical Prowess: Deep understanding of MES principles, Electronic Batch Records (EBR), workflow configuration, and Good Manufacturing Practices (GMP/GxP).
Validation Expertise: Proven experience with Computer System Validation (CSV) including familiarity with FDA 21 CFR Part 11 and GAMP 5.
Problem Solving: Exceptional troubleshooting skills for complex system issues.
Documentation: Strong ability to create clear, concise, and compliant documentation.
Compliance Mindset: A steadfast commitment to regulatory compliance and quality assurance.

Optional, but highly beneficial skills:

Experience with large-scale MES rollout initiatives.
Knowledge of integration with other enterprise systems such as ERP, LIMS, or SCADA.
Familiarity with ISA-95 standards.
Experience working in Agile or hybrid project delivery environments.
Previous involvement in global manufacturing operations.

What You'll Gain

The opportunity to make a tangible impact on critical pharmaceutical manufacturing processes.
Work with a forward-thinking company that values innovation and expertise.
A fully remote role providing flexibility and work-life balance.
Exposure to diverse and challenging projects within the life sciences sector.
A collaborative environment where your contributions are recognized and valued.