Computer Systems Validation Engineer/Sr. Engineer

Baltimore, MD, US
Jan 02, 2019
Required Education
Masters Degree/MBA
Position Type
Full time
Paragon Gene Therapy, now a part of Catalent, hires people with a passion to make a difference. Your expertise, coupled with our advanced technologies and collaboration with innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives.

Paragon Gene Therapy, in Baltimore & Harmans, Maryland, provides industry-leading GMP development and manufacturing services for cutting-edge biopharmaceuticals such as recombinant viral vectors, next generation vaccines & hard-to-express recombinant proteins and oncolytic viruses.

The Computer Systems Validation Engineer / Sr. Computer Systems Validation Engineer will work in an FDA regulated cGMP environment, validate/qualify Computer System
equipment, cloud systems, systems and processes in accordance with regulatory requirements and company manufacturing standards.

Key Responsibilities:

  • Generates, executes and reviews master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria
  • Developing validation strategies for new, proposed, or modified systems.
  • Ensuring that systems remain in a validated state.
  • Assist in training and mentoring staff in the technical competencies of validation and in contributing to validation projects.
  • Cataloging and tracking of project specific validation documentation.
  • Assist client business functions and management by reviewing and providing input on validation issues.
  • Act as the Data Integrity, CSV and regulatory compliance contact and subject matter expert.
  • Develop and implement SOPs and other procedural documents.
  • Assist in the creation of training materials, guides and templates.
  • Represent client in vendor audits and regulatory inspections.
  • Develop strategies to ensure client systems remain "audit-ready".
  • Review or conduct audits to support the implementation of third-party systems.
  • Ensure that recommendations are addressed and applicable actions completed.
  • Represent client in meetings with sponsors and vendors. Perform other duties as assigned.

Education & Experience:
  • Bachelor degree in a Science or Engineering field required
  • Computer Validation Engineer: 5 year's experience of working within organizations employing US FDA CFR's, ICH, ISO as well as the GAMP guidance
  • Sr. Computer Validation Engineer: 8 year's experience of working within organizations employing US FDA CFR's, ICH, ISO as well as the GAMP guidance
  • Advanced MS-Office (Excel, MS-Project, PP, Visio.
  • Experience in Pharma computerized systems i.e. EDMS, TrackWise, LIMS, Empower, LMS, ERP (Oracle or SAP) etc., and/or Laboratory systems.
  • Experience of creating and maintaining training materials and delivering training.

Paragon Bioservices is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.