Department: Azzur Cleanrooms On Demand Boston LLC
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 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 5 core values; Integrity, 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.
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.
- Lead the design, development, implementation, and execution of test scripts/test plans to identify software problems and their causes.
- Coordinate and execute performance and functional testing associated with multiple concurrent development and/or infrastructure projects.
- Perform testing of the entire SDLC, including version/change control and new software rollouts.
- Develop releases on multiple platforms to ensure that all code released to production systems meet or exceed pre-defined quality standards.
- Utilize knowledge of all phases of Software Project Development Life Cycle and broad contribution to Analysis, Design, Development, Testing and Deployment of Software Applications.
- Ensure that the testing is sufficient to meet regulatory requirements (21 CFR Part 11, ISO 13485, ISO 14971).
- BS in Engineering, Science or equivalent technical degree.
- 7-10 years experience in validation services in a regulated, manufacturing environment within the biotechnology, pharmaceutical, or medical device industry
- Experience in developing lifecycle documentation for computer systems (e.g. requirements specifications, risk assessments, plans, traceability matrix, protocols, reports)
- Experience in executing validation documents for computer systems
- Experience with project management
- Strong knowledge of FDA and cGMP regulations and documentation practices
- Strong knowledge of GAMP 5
- Strong knowledge of 21 CFR Part 11 and Annex 11
- Strong knowledge of computer system validation methodologies
- Ability to interpret and carry out instructions furnished in written, oral, diagram, mathematical, or schedule form
- Ability to define problems, collect data, establish facts and draw valid conclusions
- Proficient in Microsoft Word, Excel, and PowerPoint
- Master of Science in Engineering, Science or equivalent
- Validation of manufacturing control systems
- Validation of building automation/management systems
- implementation and Validation of EDMS and QMS
- Implementation and Validation of laboratory software systems (e.g. LIMS, Empower)
- Implementation and Validation of cloud based system
- Network infrastructure
- IEC 62304, ISO13485 regulated Quality system
- Medical device software V&V (embedded software)
Perks of Working at Azzur
- Medical, Dental and Vision
- Competitive 401K plan
- Volunteer Paid Time Off
- Flexible Paid Vacation Time
- Employee Recognition Program
- Diversity and Inclusion Initiatives
- Training and Mentorship Opportunities
Who we are:
The Cleanrooms On-Demand model is an alternative to building out new cleanrooms or utilizing a CMO. Our clients utilize the cleanroom space and facility infrastructure (such as EM, waste management, security, etc.) with the option to add on additional services as needed while maintaining ownership of their IP and their process. In essence, we provide the GMP envelope around the clinical manufacturing activities that our clients perform in our cleanrooms. The goal for our clients is an accelerated timeline to clinic, flexibility, and cost savings.
Azzur Group is an equal opportunity employer and promotes diverse cultures, ethnicities, gender, and ages 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.