Department: Azzur of North Carolina, LLC
Candidates should include a good mix of mid to high experience levels with proficiency in equipment, computer and cleaning/ sterilization validation.
• Provide technical knowledge and expertise in support of pharmaceutical, medical device, and/or biologics manufacturing and packaging equipment and processes.
• Perform commissioning and qualification activities for implementation of new facility/utility/equipment systems and manufacturing processes for pharmaceutical, medical device, and/or biologics production in a regulated environment (FDA, ISO, DEA, OSHA, etc.)
• Develop, review, and submit for final approval installation, operational, and performance qualification (IQ/OQ/PQ) protocols and final reports with minimal guidance and supervision.
• Develop specifications as needed for equipment/systems. Work closely with equipment vendors to ensure thorough and accurate documentation is gathered during the installation and start up processes.
• Develop critical parameters needed for follow up validation testing of equipment and processes. Provide input to test parameters, critical process parameters, to master batch records (MBRs), and validation documentation. Author procedures when necessary.
• Leverage understanding of the basic principles of technology transfer, process investigations, scale-up, process validation, and optimization of manufacturing processes spanning the entire product lifecycle.
• Monitor manufacturing and packaging processes during initial production run to assess any technical process issues.
• Clearly and accurately document activities across the validation life cycle as requested while following all good documentation and record keeping practices.
• Understand and strictly follow all technical and cGMP policies and procedures to maintain substantial compliance to applicable regulations.
• Execute a strong understanding of safety policies.
• Be self-motivated and demonstrate the ability to work with multi-functional team to meet goals and achieve results.
• Exhibit competency with computer skills required to support data collection/analysis, comparative and statistical evaluations, and professional-level reports/presentations including graphs and charts.
• Develop, review and perform appropriate testing strategies and standards and provide input on all CSV activities and documentation requirements, including but not limited to: Validation Master Plans, Validation Risk Assessments, Validation Project Plans, User/Functional Requirement/Design/Configuration Specifications, Qualification Protocols, Validation Final Report, and Change Controls/Compliance Reviews
• Prepare CSV SOP's, and related CQV deliverables obtaining guidance from Information Technology and applicable departments.
• Review/audit and/or approve key validation deliverables and change management deliverables for computerized systems as well as oversee testing and validation activities and assure quality of documentation
• Bachelor’s or Master's Degree
• Bachelor’s Degree with a study concentration in a scientific discipline, preferably the pharmaceutical/biopharma/med device industry.
Required Work Experience:
• For Bachelor's Degree Candidates: 8-15 yrs. experience in validation
• For Master's Degree Candidates: 7-14 yrs. experience in validation
• Experience with CQV, facilities/utilities qualification, CSV, cleaning validation,
and laboratory instrumentation projects (IQ/OQ/PQ). Substantial experience with CSV
and/or cleaning validation is desirable.
• GMP experience in the pharmaceutical/biopharma/med device industry
• Proficient in Microsoft and Google Suites
• MS Office, Visio and PowerPoint
• Experience with SOP authoring and SaaS/Paperless systems (e.g. Veeva) validation.
• Siemens, Rockwell, Wonderware, LabX, SAP, ControlLogix experience a plus
• Detailed knowledge of quality assurance and validation regulations, guidelines and standards (e.g. FDA, GAMP), as well as, Industry Standard Validation Best Practices (e.g. COBIT)
Reasoning Ability/Mathematical Skills/Computer
• Computer skills, basic mathematical skills, use of spreadsheets
• Customer service/client relationship management with excellent client facing skills
• Communication proficiency with ability to quickly elevate issues to the appropriate
decision makers (both client management and Azzur management)
• Able to convey technical content and available path choices clearly and concisely
• Attention to detail, priorities, and timelines
• Can work productively and independently with minor supervision
• Self-motivated, flexible, dependable, and available
• Excellent organizational and time management skills
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!