Department: Azzur Princeton, LLC
Validation Engineer demonstrating accountability, strong communication skills, and advanced knowledge of GMP project scopes, for one or more projects within Azzur Group.
Essential Duties and Responsibilities:
*Be able to help lead team in defining project strategies, developing goals, and ensures project scope is defined and controlled and requests outside the scope are identified
*Be able to clearly communicate on expertise to internal and external teams when needed
*Understand and manage deliverables of all project requirements originating from the proposal, specifications, meetings, verbal direction, or other means
*Write engineering and design specifications (URS/FS/DS) and protocols (IQ/OQ/PQ/CSV)
*Successfully validate, qualify, or requalify laboratory and / or manufacturing equipment in a regulated GxP environment
*Perform (hands on) field execution of commissioning and/or validation documentation
*Ensures identification and communication of project risks, development of risk plan and assists core team in the proactive management of risk response strategies
*Some travel may be required
*Minimum of 8 years previous experience with successful validation, qualification, or requalification of laboratory and / or manufacturing equipment in a regulated GMP environment
*Must have experience with facility and cleanroom qualification.
*Experience with gowning, locker rooms, and material airlocks preferred.
*Experience with cleanrooms (class 100) preferred.
*Minimum of a Bachelor’s of Science in Engineering or Science degree or equivalent discipline required
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!