Computer System Validation Engineer

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

Job Description

About Azzur:

Azzur is a GxP consulting organization dedicated to providing high quality, expertly backed assistance that drives pharmaceutical, Biotechnology and Medical Device companies to success. We are seeking highly motivated and talented individuals to join our incredible team.

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!


Azzur Group is an equal opportunity employer and promotes diverse cultures, ethnicities, gender, and ages in our workplace. We believe that promoting diversity plays an important role in developing top-quality talent, fostering greater innovation and creativity, and enhancing our relationships with customers and the communities in which we operate.



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