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Validation Engineer

Location: Waltham, MA

Job Description

Azzur Group of New England is a GxP compliance and consulting organization dedicated to providing high quality, expertly backed services that drives life science companies to success. United with our clients our expert staff specializes in providing services in validation(process, cleaning, shipping and computerized systems), commissioning and qualification, process and automation engineering, quality and compliance, supplier/CMO audits, facilities engineering, quality control and quality system implementation.

As Azzur continues to grow we are searching for a Validation Engineer to join our team on a full-time basis. The person in this position will be an expert consultant to our clients and will have the opportunity to work on multiple projects with some of the top biotechnology and pharmaceutical companies in the world. If meaningful work, long lasting relationships, a clear career path forward and a positive, transparent, and fun company culture are something you are looking for in your next role, Azzur is the place for you.



Essential Duties and Responsibilities

  • Generate and execute life cycle documentation (FAT, SAT, IOQ, PQ) for cleaning, shipping, facilities, utilities, systems, equipment and processes for (re)qualification/(re)verification.
  • Write, review and revise a variety of installation, operation and performance qualification/verification related documents, including any of all of the following: SOPs, validation/verification master plans, guidelines and execution plans, automation, engineering design, commissioning, qualification or other technical documents, user requirement specifications (URS), functional requirement specifications (FRS), detailed design specifications, factory acceptance test documents (FAT), verification protocols, and/or commissioning test procedures.
  • Author reports to summarize validation/verification/commissioning and/or revalidation/verification/commissioning activities.
  • Write procedures, investigations, protocols, reports change controls, etc. to support the Maintenance and Engineering departments.


Qualifications

  • Ability to travel to project sites throughout the New England area
  • Minimum of 5 years' of validation work experience in the pharmaceutical, biotechnology, or other regulated industry
  • Strong working knowledge of FDA and cGMP regulations and documentation practices
  • Ability to interpret and carry out instructions furnished in written, oral, diagram, mathematical, or schedule form
  • Ability to define problems, collect data, establish facts and draw valid conclusions
  • Proficient in Microsoft Word, Excel, and PowerPoint
 

Benefits

Who we are:

At Azzur Group, our talented people make us successful and we are committed to offering employees opportunities to grow and develop. Our benefits and compensation packages are designed to help our talented employees excel and achieve their goals, so they can make a difference every day in and outside of the workplace. Below are just a few examples!

  • Unlimited Paid Time Off
  • Medical, Dental and Vision Insurance
  • Career Development & Training Opportunities
  • 401k plan with employer contributions
  • Tuition Reimbursement

Azzur Group is an equal opportunity employer and promotes diverse culture, ethnicity, gender and age 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.


Apply Now
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