This is an associate level Validation tester position. The CSV tester will work under the supervision of the Sr. CSV Specialist to provide accountability for qualification of equipment, facilities, and utilities, as well as validation of the associated process automation. The Lead Validation Engineer will also provide guidance and mentoring to the Validation Engineers on the team.
Essential Functions
- Lead equipment, facility, and utility qualification and process automation validation for clinical and commercial manufacturing and laboratory systems
- Use ValGenesis Validation Lifecycle Management Systems to complete IQ/OQ/PQ execution
- Review change controls and assess their impact as well as define the required validation activities
- Define validation strategy in alignment with company procedures and policies
- Lead and participate within cross-functional teams to complete validation tasks and projects
- Communicate proactively with team members, stakeholders, and management regarding progress, issues, and plans for resolution and to ensure the project team and/or network is fully informed of updates and improvements
- Monitor/support on-going compliance and perform periodic system reviews ensuring that systems are maintained in a validated state
- Ensure compliance with current validation policies and legislative requirements by setting and maintaining validation standards via validation SOPs
- Support regulatory inspections and internal and partner audits, and implement corrective actions as needed. Provide validation related responses to inspectors/auditors
- Execute validation test protocols for complex systems/projects.
- Own investigations and perform root cause analysis for deviations encountered during qualification
- Serve as a subject matter expert for equipment/facility/utility qualification at Branchburg, NJ site
Required Education And Experience
- Bachelor’s degree in a scientific or engineering field
- 8+ years of relevant validation experience in a regulated environment (e.g. pharmaceutical manufacturing)
- Experience with ValGenesis Validation Lifecycle Management System
Preferred Competencies
- Able to manage multiple tasks in a fast-paced environment
- Plans and prioritizes effectively according to task urgency and importance
- Coordinates internal resources to complete validation tasks
- Uses a risk-based approach to all aspects of validation
- Must be computer literate and able to effectively use the MS Office suite of products
- Experience with MasterControl, ProCal and LIMS
- Experience working with Ellab wireless dataloggers and EvalPro monitoring systems is a plus
- Systematically analyzes data and draws sound conclusions
- Able to work independently once competency/training is established
- Able to work as part of a team on a variety of complex and non-complex projects
- Identifies solutions to both complex and non-complex problems based on facts and data
- Actively seeks direction when necessary
- Counts self as accountable for the completion of assigned tasks
- Contributes constructively within the department in an open an honest manner
- Excellent written and oral communicator
- Demonstrates initiative and attention to detail
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!