Siemens Opcenter Validation Engineer

Overview

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 partnerships with companies like Microsoft, Google, Oracle, Docu Sign, 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.

We are seeking an experienced MES Validation Resource with experience in Siemens Opcenter to support validation activities within a regulated biotech/pharmaceutical manufacturing environment. The ideal candidate will have a strong background in Computerized System Validation (CSV), with a proven track record of testing MES applications in compliance with FDA 21 CFR Part 11, EU Annex 11, and other regulatory requirements.

• Develop validation documentation such as validation plans, functional design specifications, test protocols, and standard operation procedures for computerized systems used in GMP environment. Analyze complex manufacturing business processes and identify, evaluate, develop and/or redesign systems, processes, and procedures to meet user requirements on large initiatives.
• Review and update user requirements and functional specifications.
• Responsible for planning, scheduling, and leading validation assignments.
• Demonstrate competent and effective planning, coordination, and organizational skills.
• Participate and work closely with cross-functional team members (Engineering, Manufacturing, Quality Operations, Quality Validation, Supply Chain, and other technical disciplines) representing the respective validation elements to develop the validation strategy and system validation requirements based on concepts of risk-based CQV which includes user requirements, functional specifications, design specifications, commissioning and validation.
• Emphasis is following regulatory guidelines and industry standards.
• Execute protocols, write reports, interpret, and evaluate validation documents in terms of acceptability to industry standards, procedures, and regulatory requirements.
• Review documentation for accuracy and compliance to established procedures with the ability to approve or reject as appropriate.
• Validate interface data transfer between integrated systems to ensure data integrity, traceability, and proper system data retrieval.
• Maintain accurate validation records and documentation (including validation plans, functional specifications, protocols, and SOPs) to support compliance, audits, and inspections in GMP environments.
• Maintain accurate and complete records of validation and testing activities to support audits and inspections.
• Identify, log, and track software defects and discrepancies.
• Collaborate with development and quality validation teams to troubleshoot and resolve issues.
• Lead and coordinate validation assignments, demonstrating strong organizational and planning skills while shaping validation strategies based on risk-based CQV principles.
• Continuously recommend and implement improvements to validation methods, tools, and documentation standards to drive efficiency and maintain compliance.
• Ability to present a course of action to management and project team using both written and verbal communication tools.
• Perform other duties as directed by supervisor.

• Performs other related duties and assignments as required

• Hands-on validation experience with Siemens Opcenter is…