Department: Azzur of NE, LLC
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.
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.