CQV Engineer

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

Job Description

Azzur personnel are expected to live up to our core values at all times and exhibit a high level of integrity and personal responsibility, especially when interacting with our valued clients. The following is a short list of the typical responsibilities and deliverables of any given project. The level of knowledge expected will be commensurate with level of incoming experience.

Responsibilities:

 Draft and execute Commissioning and Qualification (C&Q) documentation and services for client facility, utility, process, and equipment (Manufacturing and QC Lab)
 Performs/executes the validation/verification studies (FAT, SAT, CTP, IQ, OQ, PQ) for cleaning, sterilization, equipment, systems, utilities, and processes for qualification and/or requalification.
 Author specifications, assessments, and test protocols across a diverse Life Science market comprised of Pharmaceuticals, Biotechnology, Cell & Gene Therapy, and Medical Device clients
 Assist in the development and implementation of Quality Management System (QMS) procedures, in harmony with regulatory standards such as 21 CFR Part 210 and 211 Part 11, ICH Q8, ICH Q9, and ICH Q10, and Annex 11.  Collaborate with teams to perform investigations, diagnose problems, and troubleshoot validation issues
 Prepare written validation reports with high level of detail and organization
 Communicate with project stakeholders the progress relative to plan
 Manage project deliverables to agreed schedule and scope
 Make an impact day-to-day with your skills and expertise, strengthening that relationship with our clients and team.
 Evaluate processes, propose solutions resolve issues and communicate results to support project/task completion.
 Develop and complete deliverables related to CQV activities as needed to ensure objectives are met.

Qualification and Requirements:

 A passion for a career in the Life Science industry
 Excellent communication and interpersonal skills and ability to interact with all levels of management, clients, and vendors
 Bachelor’s or master’s degree in Bioengineering, Biomedical Engineering, Mechanical Engineering, Chemical Engineering, or Science related technical degree preferred.
 3-5 years’ experience of validation and/or quality in a regulated, manufacturing environment within the biotechnology, pharmaceutical or medical device industry.
 3+ years project experience with authoring and executing validation protocols of manufacturing process equipment and QC lab equipment, automation/computerized systems, and/or utilities and facilities
 Experience in the areas of validation lifecycle documentation (URS, System Classification, Risk Assessment, Design Reviews), and Validation Protocols (IQ, OQ, PQ, PV, CSV, requalification/periodic reviews) etc.
 Experience with Quality Systems (handling Change Controls, Non-Conformances, Deviations, CAPAs)
 Proficient in computer skills (Microsoft Office, Microsoft Project/Smartsheet)
 Proficient with written and verbal technical communication including generating protocols/reports and conducting group presentations.
 Willing and able to travel as necessary for project requirements to include but not be limited to project work activities, client meetings, company sponsored meetings, trainings, industry related forums, or conventions, etc.

About Azzur

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.


Do What You Love

At Azzur, we look for talented individuals who take pride in the work they do. We foster employee growth by encouraging our employees to focus on doing what they love and what they do best.

Azzur is a GxP compliance and consulting organization dedicated to providing high quality, expertly backed, assistance that drives life science companies to success.  We are seeking highly motivated and talented individuals to join our incredible team of skilled problem solvers.  Qualified candidates must have a desire to learn, apply, engage, and adapt in the ever-changing healthcare field while simultaneously and organically exuding Azzur’s core values:

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


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