Job Description

Job Description

About USDM

USDM Life Sciences is a premier consulting company with 20+ years of experience assisting heavily regulated biotech, medical device, and pharmaceutical companies with their GxP technologies to accelerate growth. Our deep domain knowledge and technology expertise in life sciences business processes are what set us apart. From strategy to implementation and adoption, we have delivered thousands of GxP projects globally.

As part of the USDM team, you have the opportunity to work with cutting-edge technologies through our many partnerships with companies like Microsoft, Google, Oracle, DocuSign, Box, and many more. From molecule to market, you will help connect technology, people, and data in new ways to generate real-time insights to improve business outcomes for USDM’s clients. Are you ready to make an impact and drive real digital transformation in life sciences?

Founded in Santa Barbara in 1999, USDM has grown to a progressive, global company with 300+ remote employees and offices throughout the US, Canada, and Germany.

Nature and Scope of Job

The MES Developer will design, configure, and deploy MES solutions to support production operations and ensure regulatory compliance. Collaborate with manufacturing, engineering, quality, IT, and system teams to gather requirements, translate them into technical specifications, and develop functional designs. Implement compliant MES process instructions aligned with manufacturing workflows and industry standards such as cGMP, FDA, ISPE, and GAMP 5.

Primary Responsibilities

• Design, configure, and deploy MES solutions (primarily Siemens XFP and Rockwell PharmaSuite) to meet production and compliance requirements.
• Collaborate with cross‐functional teams, including but, not limited to Manufacturing SME’s,
• Process Engineering, MS, Quality Assurance, Quality Validation, IT, and the respective computerized system teams related to MES interfaces—to gather and analyze business and process requirements.
• Convert gathered business and process requirements into detailed technical specifications and functional designs.
• Ensure MES solutions are compliant with applicable industry regulations, including cGMP, FDA, ISPE, and GAMP 5 standards.
• Design, develop, and implement MES process instructions aligned with manufacturing workflows and business requirements.
• Set‐up system parameters, master data, and configuration settings.
• Implement and manage data synchronization processes to maintain consistency and accuracy across MES and other enterprise systems
• Develop and support integration workflows between MES and enterprise systems such as JDE, LabWare, OSI PI, and plant automation equipment (e.g., DeltaV).
• Perform comprehensive integration testing to ensure seamless data exchange between MES and connected systems, resolving any issues discovered during testing.
• Analyze existing MES code and scripts to understand system logic and processes and troubleshoot as necessary.
• Contributes to the configuration, development, troubleshooting, and end‐to‐end testing of MES applications and system functionalities.
• Create and maintain detailed documentation, including but not limited to: Project design traceability documents, Functional and technical design specifications, Commissioning and qualification protocols (IQ/OQ/PQ), and Test cases and validation reports.

Qualifications

• Minimum 7+ years working experience in Pharmaceutical/biotech industries.
• System Integration Experience: JDE, OSIPI, Labware, and DeltaV
• MES Platform: Siemens Opcenter Execution Process (formerly known as SIMATIC IT Unified
• Architecture for Process Industries) a plus, CAMSTAR or any other MES System
• Database Platforms: Microsoft SQL, Oracle, etc.
• Project Documentation: Microsoft Office
• Experience in FDA regulated industry and familiarity with CFR 21 Part 11, cGMP
• Technical attitude: ability to learn new systems and information quickly.
• Demonstration of in‐depth technical capabilities in system supported manufacturing in a regulated environment.
• Meticulous, conscientious, analytical, focused, self‐starter individual.
• Excellent communication skills – both verbal and written

Education & Certifications

• Bachelor's Degree required

Working Conditions

The working conditions described here are representative of those that must be met by an employee to successfully perform the essential responsibilities and functions of the job and are not meant to be all-inclusive. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential responsibilities and functions of the job.

Unless reasonable accommodations can be made, while performing this job the staff member shall:

• Prolonged periods of sitting or standing at a desk and working on a computer in an environmentally controlled home office environment.
• Operate other office productivity machinery, such as a calculator, scanner, or printer.
• Frequently communicate with stakeholders via telephone, email, or instant message. Must be able to exchange accurate information in these situations.

Equal Opportunity Statement

USDM Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Disclaimer

This job description is intended to describe the general nature and the level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. USDM Life Sciences reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

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