Validation Engineer
Description
ABOUT THE COMPANY
From Discovery to Delivery™, Azzur Group provides the life science community full life-cycle solutions for all their GxP needs. From Azzur Cleanrooms on Demand™ facilities, to our labs, training centers and consulting offices across the nation, Azzur Group helps organizations start, scale, and sustain their growing enterprises. With nearly four decades of service to the life science community, we have become a trusted partner to the world's leading pharmaceutical, biotechnology, medical device, and healthcare companies, as well as their supply chain.
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.
- Development and editing of SOPs
- Development and execution of validation test procedures
- Development of project plans, as appropriate
- Thermal mapping of temperature controlled chambers, warehouses, and SIP processes
- Technical presentations
- Technical report writing
- Data Analysis
- P&ID walkdowns
Qualifications:
- BS in Engineering, Science, or equivalent technical degree.
- 4+ years experience in a regulated, manufacturing environment within the biotechnology, pharmaceutical, or medical device industry.
- Experience in the areas of design documentation (URS, FS, DS and other engineering specifications) Validation (IQ,OQ,PQ,PV,CV, CSV, etc), Quality Systems (Change Control, Non-conformances, Re-qualification, etc) and Process Excellent Methodologies (Six Sigma, Lean, etc).
- Excellent written and verbal communication skills; excellent technical writing skills.
- Strong interpersonal skills and the ability to work in a team environment.
- Ability to work effectively in a fast paced multitasking environment.
- Strong working knowledge of FDA and cGMP regulations and documentation practices.
- Proficient in Microsoft Word, Excel, PowerPoint.
- Working for multiple clients throughout the region.
Do What You Love
At Azzur Group, it is our purpose to foster a culture that attracts and enables individuals with unique abilities and passions to reach both their life and career goals. We take crucial steps to ensure that each employee is fulfilled both in and out of the office.
In addition to our purpose, we have a set of core values that we live and breathe each day. Every benefit offered here at Azzur is designed to uphold our 4 core values; Putting Others First, Having the Courage to Take Action, Taking Personal Responsibility and Having Fun.
It is our mission to serve our communities, build positive and established relationships, create a healthy and fun work environment, ensure each employee and their families are healthy and thriving, grow each employee professionally with one of our customized training programs and keep a clear and open line of communication.
We are an equal opportunity employer and promote diverse culture, ethnicity, gender, and age in our workplace. We believe that promoting diversity plays an important role in developing top quality talent, fostering greater innovation and creativity, and enhancing our relationships with customers and the communities in which we operate.
If philanthropy, long lasting relationships, a clear career path forward and a positive, transparent, and fun company culture are something you are looking for in your next role, Azzur is the place for you.
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 – must have the ability to transform knowledge into actionable activities
- Able to produce results in a fast paced, collaborative environment
#LI-JB1
Azzur Core Values:
Puts Others First...Have the Courage to Take Action…Take Personal Responsibilities…Have Fun!