USDM Life Sciences · 5 hours ago
Siemens Opcenter Validation Engineer
United States
Full-time
Remote
Senior Level
$70/hr - $85/hr
7+ years expUSDM Life Sciences is a premier consulting company with over 20 years of experience in the life sciences sector. They are seeking a Siemens Opcenter Validation Engineer to support validation activities in a regulated biotech/pharmaceutical manufacturing environment, focusing on developing validation documentation and ensuring compliance with regulatory requirements.
BiotechnologyInformation Technology
Responsibilities
Develop validation documentation such as validation plans, functional design specifications, test protocols, and standard operation procedures for computerized systems used in GMP environment Analysis 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
Must 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, as applicable, 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
Qualification
Required
Hands on experience with Siemens Opcenter is required
Experience in pharmaceutical/biotech validation which includes the writing and executing of protocols and standard operating procedures
Experience in manufacturing processes and control systems
Strong knowledge of GMPs, FDA and EU guidelines/requirements, is required
Proficient in writing test cases, test scripts, and validation documentation
Experience with test management and defect tracking tools (e.g., Jira, TestRail, HP ALM)
Understanding of system development life cycle (SDLC) and Agile/Waterfall methodologies
Exposure to enterprise systems such as ERP, LIMS, DeltaV, OSIPI or other business-critical applications
Bachelor's degree in engineering discipline required
7+ years of related experience
Benefits
Health, vision, and dental insurance
Life insurance
Short and long-term disability
Hospital indemnity
Accident, and critical care coverage
401k plan
Paid time off
USDM's rewards and recognition program
Company
USDM Life Sciences
USDM Life Sciences makes it easier to accelerate innovation and maximize human productivity.
201-500 employees
H1B Sponsorship
USDM Life Sciences has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (2)
2023 (2)
2022 (5)
2021 (3)
2020 (8)
Funding
Current Stage
Growth StageLeadership Team
Jay Crowley
VP Medical Devices and UDI Practice Lead
Kevin Brown
Managing Partner
Recent News
2023-08-08
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