Department: Azzur Princeton, LLC
With a steadfast dedication to our industry, clients, and the Azzurians that make it all possible, our network offers professional services with efficiency, innovation, and a commitment to meeting compliance needs. We provide carefully calibrated project management, process engineering, and compliance solutions with an Azzur twist. We demonstrate our Core Values in everything we do!
Put Others First, Courage to Take Action, Take Personal Responsibility and Have Fun!
· 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
• A Bachelors or Associates degree in a technical discipline is required
• A minimum of 5+ years of equipment qualification experience in a regulated environment, including CSV is required
• Must be able to adhere to all applicable procedures, cGMPs, company policies and any other quality or regulatory requirements. (For example: FDA, EMEA, OSHA, HS&E, etc.)
• Manage, plan and schedule qualification activities with the System Owner(s) and third party service providers
• Provide oversight and/or perform equipment and systems qualification, including CSV
• 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.