Computer System Validation Csv Jobs in Maryland (NOW HIRING)

Position Summary
The Principal Solutions Architect - PLM & Digital Thread is a strategic technical leader who owns three mandates: (1) architect and implement Siemens Teamcenter X as the backbone of MSD's digital thread, (2) design and maintain integrations between PLM, Manufacturing Execution Systems (MES), and JD Edwards EnterpriseOne (JDE) ERP to ensure end-to-end data continuity across the product lifecycle, and (3) own the ongoing operational stability, support, and continuous improvement of these systems in production.
Working in close partnership with the Digital Thread Process Lead - who defines strategy and process requirements - this role translates those requirements into scalable, cloud-based technical solutions. The ideal candidate brings deep PLM domain expertise, a transformation mindset, and hands-on experience driving enterprise system implementations in FDA-regulated or GxP environments.
Duties and Responsibilities
Technical Architecture & Implementation
• Architect, configure, and implement PLM solutions in Teamcenter X to support engineering, quality, and manufacturing processes - with a focus on establishing a unified digital thread from product design through manufacturing execution and commercial operations.
• Partner with the Digital Thread Process Lead to translate defined process requirements into Teamcenter X configurations, workflows, and integrations.
• Serve as the subject matter expert on Siemens Teamcenter X: administer the platform, stay current with SaaS release cycles, and drive adoption of evolving best practices.
Integration & Enterprise Data Flows
• Design and maintain integrations between Teamcenter X, MES platforms, and JD Edwards EnterpriseOne (JDE) - ensuring data integrity and process continuity across the product lifecycle.
• Design contextually relevant MES integrations covering work order execution, shop floor routing, material tracking, and production traceability.
• Support data-flow design between ERP and PLM/MES layers, including manufacturing, procurement, quality management, and inventory modules in JDE.
• Implement and maintain integrations with CAD tools (including ECAD), laboratory systems, and other enterprise applications.
Operational Support & Continuous Improvement
• Provide ongoing operational support for Teamcenter X and its integrated systems - including incident response, break/fix resolution, user support, system health monitoring, and vendor escalation coordination.
• Troubleshoot and resolve software issues across the PLM and integration stack.
• Drive continuous improvement of the PLM platform and integration architecture in alignment with MSD's digital transformation roadmap.
Leadership & Collaboration
• Lead architecture discussions and design technical solutions in support of business partners' digital transformation initiatives.
• Collaborate with cross-functional teams and business/functional analysts to gather requirements, create specifications, and deliver validated solutions that meet 21 CFR Part 11 and GxP requirements.
• Collaborate with business process owners and the project management office to define implementation plans, manage priority items, and align PLM roadmap milestones with digital transformation program objectives.
• Ensure testing is appropriate and complete, business process procedures are accurate, and all configuration and validation standards are adhered to.
• Coach team members to build internal PLM technical capability and reduce dependency on external resources.
Experience and Qualifications
Required
• Bachelor's degree in Computer Science, Engineering, or a related field.
• 7+ years of hands-on experience with Siemens Teamcenter PLM, including implementation, configuration, upgrading, and administration across multiple versions and releases.
• Proven track record as a Solutions Architect or senior PLM technical leader, with demonstrated experience implementing digital thread processes in partnership with business process owners.
• Demonstrated experience designing integrations between PLM and downstream enterprise systems (MES and/or ERP).
• In-depth knowledge of core Teamcenter modules: Active Workspace, BMIDE, workflow design, change management, and data models.
• Experience implementing PLM in FDA-regulated or GxP environments, including computer system validation and 21 CFR Part 11 compliance.
• Transformational experience: demonstrated history of leading or significantly contributing to enterprise-scale PLM implementations that changed how an organization operates - not just maintained existing systems.
Preferred
• Direct experience with Teamcenter X (cloud/SaaS PLM).
• Consulting experience across multiple customers and implementations in the life sciences industry.
• Experience architecting integrations specifically with JD Edwards EnterpriseOne (JDE).
• Working knowledge of MES principles and manufacturing data flows, including work order management, shop floor routing, and production traceability in both discrete and process manufacturing.
• Familiarity with digital thread concepts: Production configuration management, routers, BOM lifecycle management, document management, change management and closed-loop quality integration across enterprise systems.
• Experience supporting ISO 9001 quality management systems.
Knowledge, Skills and Abilities
Technical Skills
• Expert-level knowledge of Siemens Teamcenter X and the broader Siemens digital industries ecosystem.
• Demonstrated ability to implement integration frameworks connecting PLM to MES and ERP platforms under the direction of a process owner.
• Knowledge of C#, Visual Basic, JavaScript, MSSQL, and/or XML.
• Knowledge of Agile methodologies (e.g., Scrum).
Domain Knowledge
• Working knowledge across the majority of: Product Design & Development, Engineering, Software Design, Manufacturing, Quality, and Validation.
Leadership & Communication
• Ability to explain complex technical architecture to non-technical stakeholders and executive leadership.
• Solid technical leadership with demonstrated staff management, accountability setting, and performance management capabilities.
• Excellent analytical and logical problem-solving skills with the ability to organize and drive project tasks forward in a structured fashion.
• Strong drive to increase business value through continuous improvement.
• Excellent oral, written, and interpersonal communication skills.
Physical Demands
This position requires the ability to communicate and exchange information, utilize equipment necessary to perform the job, and move about the office and facilities.
Work Environment
This position is performed in a traditional office environment, remote work, or a hybrid model.
COMPENSATION SUMMARY
The annual base salary for this position ranges from $116,600 to $177,800. This salary range represents a general guideline as MSD considers other factors when presenting an offer of employment, such as scope and responsibilities of the position, external market factors, and the candidate's knowledge, skills, abilities, education and experience. Employees may qualify for a discretionary or non-discretionary bonus in addition to their base salary. These annual bonuses are intended to recognize individual performance and enable employees to benefit from the Company's overall success.
BENEFITS SUMMARY
At MSD, we offer a comprehensive benefits package to support our employees' well-being and financial security. In addition to competitive salaries, our benefits include medical, dental, and vision coverage, along with prescription benefits. We provide a 401(k) plan with company matching, flexible spending accounts, and company-paid short- and long-term disability insurance as well as group life and accidental death and dismemberment insurance. Our offerings also encompass paid vacation, paid sick leave, paid holidays, and paid parental leave, along with an employee assistance program. Additional voluntary perks include a fitness club membership contribution, pet insurance, identity theft protection, home and auto insurance discounts, and optional supplemental life insurance.
EEO/AA STATEMENT
MSD is an Equal Opportunity/Affirmative Action Employer. We are committed to fostering a diverse and inclusive workplace where all individuals are treated with respect and dignity. We welcome applications from all qualified candidates, making employment decisions without regard to race, color, religion, creed, sex, sexual orientation, gender identity, genetic information, marital status, national origin, age, protected veteran status, pregnancy, disability status, or any other protected characteristic. For our full EEO/AA and Pay Transparency statement, please visit here. Meso Scale Diagnostics uses E-Verify to validate the work eligibility of candidates.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
This employer is required to notify all applicants of their rights pursuant to federal employment laws.
For further information, please review the Know Your Rights notice from the Department of Labor.