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Senior Computer Systems Validation (CSV-IT) Consultant
at Azzur Group
Boston, MA

Senior Computer Systems Validation (CSV-IT) Consultant
at Azzur Group
Boston, MA

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Description

Job Description

Azzur Group is currently looking for Sr Level CSV-IT Consultants for site-based roles in the Greater Boston Area! These are full time positions with competitive benefits and compensation.

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!

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 Can Offer:

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

Responsibilities:
(Project specific responsibility may be discussed with you during your interview process):

  • 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.
  • Responsible for executing and reviewing control systems validation activities including projects associated with PCS, BMS, CMS, OSI PI, and other automation upgrades.
  • 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.
  • Execute and deliver on all assigned work ensuring customer satisfaction.
  • Exemplifies Azzur’s Core Values
  • Represents Azzur at client sites; is punctual and reliable.
  • Provide recommendations for improvement to the client as needed or observed.
  • Report weekly project status to Director of Engineering.
  • Attend and engage in Azzur events and happenings including quarterly meetings and social events
  • Complies with all Azzur agreements, policies, and procedures.
  • Flexibility to travel to various location across the New England area.

Ideal Qualities / Qualifications:

  • 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 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 implementations.
  • 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.
  • Ability to handle multiple projects

Company Description

Our employees are fueled by an entrepreneurial spirit and the desire to make a difference in the lives of our customers, coworkers and our partners. If you’re ready to put in the work, take personal responsibility and test the limits of what’s possible, we’re ready to provide the reward.

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