Cleaning Validation Engineer
Description
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!
Ideal Qualities:
Ideal candidates will exhibit, or have the willingness to develop, the following qualities:
- Strategic thinker with strong analytical skills who can translate client needs into actionable value-added projects/results
- Understands the competitive landscape of the medical device, pharmaceutical, and biotechnology industry
- Willing to work hands on, assist with building client libraries, learn from a mentor and become a mentor for others.
- Understands worldwide regulations and phase appropriate applications
- Draws insights from projects and supplemental research to help drive new and existing growth.
- Ensures activities are efficient, optimized, and client-centric.
- Highly motivated and organized, solutions oriented leader
- Curious and adaptable - has the ability to transform knowledge into actionable activities
- Able to produce results in a fast paced, collaborative environment
Essential Duties and Responsibilities
Azzur personnel are expected to live up to our core values at all times and exhibit a high level of integrity and personal responsibility, especially when interacting with our valued clients. The following is a short list of the typical responsibilities and deliverables of any given project. The level of knowledge expected will be commensurate with level of incoming experience.
- Draft cleaning validation protocols and final reports
- Perform cleaning validation execution
- Support cleaning validation activities for a variety of client projects such as: a new product transfer into facility, facility capacity increase and process change support.
- Experience with glass and parts washers, CIP skids, COP
- Experience with manufacturing equipment CIP cycles and cycle development
- Experience with CIP/COP of vessels, tanks, etc.
Qualifications
- Engineering Degree required.
- 2-6 years experience with cleaning validation in a regulated environment
- Working knowledge of FDA and cGMP regulations and documentation practices.
- Excellent written and verbal communication and technical writing skills.
- Proficient in Microsoft Office Suite and able to learn new computer applications.
- Must be results oriented with hands-on experience with validation execution, familiar with industry concepts, practices, and procedures in a cGMP environment
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