QC Lab Equipment Qualification Engineer

Location: Worcester, MA
Department: Azzur Worcester, 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:

Perform Qualifications of QC Lab Equipment which includes, TOC Analyzer, SoloVPE, BSC, pH Meters, FIT Testers, HPLC, GC, qPCR Systems, Thermomixers, Plate Reader, Endotoxin Reader, Analytical Balances, etc.
Draft Data Integrity Assessment and ERES Assessment for instruments.
Author User Requirement Specification (URS) and/or Functional Requirement Specifications.
Write and execute qualification protocols (IQ, OQ), reports as a part of validation and oversee vendor execution.
Author and review technical documents, and reports and traceability Matrix as applicable.
Execute OQ and log discrepancies and deviations and documented resolutions.
Have knowledge of the FDA regulations and GAMP 5 guide.

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!

Azzur Group is an equal opportunity employer and promotes a diverse culture 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.  All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status. 


#LI-PP1



Apply Now

Life Science Moves FAST

Stay in the know by signing up for our newsletter. We’ll share company successes, industry must-know information, and keep you updated on the latest events you don’t want to miss.