Pharmaceutical Systems Validation Engineer

1 week ago

Reston, Virginia, United States MMR Consulting Full time
Computer System Validation Engineer

MMR Consulting is a leading engineering and consulting firm specializing in the pharmaceutical and biotechnology industries. Our services include engineering, project management, and consulting services. We have expertise in process, automation, and facilities engineering, as well as pharmaceutical expertise in oral solid dosage, semi-solids, liquid-dosage, API manufacturing, and biotechnology.

This is an exciting opportunity to join our team of engineers working on the design, project management, commissioning, and start-up of various processes, systems, and facilities. As a Computer System Validation Engineer, you will work with our client in the Texas facilities.

Responsibilities
  • Develop and approve validation documentation, risk assessments, and other related deliverables.
  • Collaborate with project teams to determine which elements should be validated and conduct impact assessments of proposed changes to computerized systems.
  • Generate, obtain approvals, and execute validation deliverables for computerized systems and relevant infrastructure, including validation plans, requirements specifications, risk assessments, installation/operational qualifications, traceability matrices, and validation final reports.
  • Plan and organize validation activities among cross-functional groups and provide status updates for validation activities related to day-to-day operations or project work.
  • Work independently with minimal guidance from senior engineers and/or CSV managers to author protocols, execute, analyze data, and author reports.
  • Review all System Delivery Life Cycle (SDLC) deliverables, provide constructive feedback, and ensure that deliverables adhere to associated Standard Operating Procedures (SOPs).
  • Create, review, and update SOPs, forms, templates, documentation, and files.
  • Perform all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable laws, regulations, and industry codes.
  • Perform other duties as assigned.
Qualifications
  • Bachelor of Science in Electrical Engineering or equivalent technical training.
  • Minimum 8 years of working knowledge and expertise in computerized systems validation in biotech or pharmaceutical organizations.
  • Ability to work with minimal direct supervision, meet deadlines, prioritize assignments, provide recommendations, and effectively communicate updates.
  • Computer System Validation experience with DCS, SCADA, and BMS systems such as DeltaV, Factory Talk View, Desigo, Unicorn, and Wonderware is preferred.
  • Knowledge of 21 CFR Part 11, Annex 11, Data Integrity, GAMP5 requirements, and FDA industry regulations.
  • Excellent written and oral communication skills.
  • Working knowledge and experience in Microsoft Office products (Outlook, Word, Excel, PowerPoint).
  • Desire to work in a fast-paced, state-of-the-art, alternately research and customized manufacturing facility.
  • Must be proficient with Internet navigation, Microsoft Office (Outlook, Word, PowerPoint, Excel, Project, Teams, SharePoint), Adobe Acrobat.
  • Should be flexible to working outside core business hours (occasionally on short notice, and a limited basis), as needed.
  • Proven ability to manage multiple and fast-moving priorities.
  • Ability to work well in a fast-paced collaborative team environment within a rapidly evolving business environment.
  • Skilled at solving multi-dimensional problems with both quantitative and qualitative variables.
  • Ability to lead and influence others in support of company objectives.
  • Excellent decision-making and cross-functional team-building skills.
  • Solid understanding of GMP, GLP, and non-GMP project requirements.
  • Able to read and understand engineering plans and specifications.
  • Demonstrated ability to build strong working relationships.

MMR Consulting is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision, and dental coverage, group and supplemental life insurance, 401(k) with company match, etc. To learn more about MMR, please visit our website.

MMR Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Our hiring decisions are based on merit, qualifications, and business needs. We are committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please let us know the nature of your request.

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