Computer System Validation Engineer (Consultant)

Location: Waltham, MA
Department: Azzur of NE, LLC

Job Description

Essential Duties and Responsibilities

  • Generate, review and approve validation and compliance documents supporting GxP computerized systems, and relevant infrastructure, including those related to system procurement, audit, performance, compliance evaluation, and validation.
  • Provide support for SOPs, qualification protocols, gap assessments, risk assessment, Impact Assessment, user requirements, functional and configuration specifications, requirements traceability, validation plans, validation summary reports and change controls.
  • Execute protocol execution, documentation of results, deviations, and corrective actions, and preparation of Summary Reports, Trace Matrices and Summary Reports associated with validated computer systems
  • Perform Gap Assessments and Remediation Plans with an understanding of applying risk management principles.
  • Ensure regulations, such as 21 CFR Part 11, 820 and cGMP, are addressed in validation.
  • Performs periodic reviews and ongoing support of validated systems post Go-Live.
  • Perform revalidation and change control validation related activities.
  • Assess the impact of system changes through change management and change control systems; participate in the planning and implementation of change.
  • Provide training to colleagues and contractors on systems implementation and validation SOPs.
  • Assist validation activities of cross-functional teams that include technical functions such as Information Systems, Manufacturing and QA Engineering.
  • Develop and maintain Validation SOPs, forms, documentation and files.

Requirements

  • Five plus (5+) years of relevant CSV, validation, automation, and engineering experience within a cGMP environment
  • Computer systems experience with manufacturing, equipment and process, as well as utilities, and facilities qualification.
  • Experience in Labeling/Packaging System Validation is preferred.
  • Experience in the biotechnology and/medical or pharmaceutical industry required.
  • Proficiency of Computers Systems Validation and Quality Systems.
  • GMP compliance knowledge including knowledge of 21 CFR Parts 11, 210, 211, and 820 requirements, Data Integrity, ICH Q7A requirements, and GAMP
  • Experience in thorough testing of applications, computerized systems, changes and implementation
  • Experience with Veeva platform and applications a plus
  • Excellent written and verbal communication
  • Ability to work in a fast-paced environment.
  • Team oriented with independent work skills and a strong work ethic.
  • Microsoft Office and database management skills.

Benefits

Who we are:

Azzur Group is a professional service company providing biotechnology and pharmaceutical clients with engineering, validation, CSV-IT, technical, and consulting services. At Azzur, we look to hire full-time consultants who deliver results to our valued clients while providing you the opportunity to develop and grow in the industry through diverse project assignments. Using our 4 Core Values as guidance, we expect all Azzur Employees to:

  • Put Others First,
  • Have the Courage to Take Action,
  • Take Personal Responsibility, and
  • Have Fun!

Azzur can offer you:

  • Flexible PTO Policy
  • Training and Development Opportunities
  • 401(k) match
  • Bonus Eligibility
  • Medical Benefits
  • Paid Holidays
  • Company provided laptop

If you can deliver high-quality customer service and results while engaging in our fun and energetic culture; we want to hear from you!

 



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