Department: Azzur of CA, LLC
Azzur Group is an equal opportunity employer and promotes 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.
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.
Ideal candidates will exhibit, or have the willingness to develop, the following qualities:
- Solid knowledge of Reliability Engineering principles
- Solid knowledge of Asset Lifecycle Management in the life sciences industry
- Firm understanding of data management and data integrity from a Centralized Maintenance Management System (CMMS) perspective
- Experience in Risk Management in terms of equipment and component criticality
- Ability to structure and facilitate FMECA, FMEA and PHA
- Experience with writing policies and procedures that govern reliability programs
- 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, and become a mentor for others
- Draws insights from projects and supplemental research to help drive new continuous improvement in reliability and maintenance processes.
- Ensures consulting services are efficient, optimized, and client centric.
- Highly motivated and organized, solutions-oriented leader
- Curious and adaptable - can transform knowledge into actionable activities
- Able to produce results in a fast paced, collaborative environment
Essential Duties and Responsibilities
Personnel are always expected to live up to our core values 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.
- Provide for the design and implementation of asset management programs including the development of governing SOPs and a process to categorize and prioritize equipment based on asset lifecycle methodology.
- Integrate best demonstrated practice and industry standards into reliability and maintenance programs
- Perform analysis of maintenance, calibration, and asset management systems to clients in order to assess limitations and suggested improvements
- Create detailed reliability standard operating procedures that encompass preventative and predictive methodologies and best practices
- Create comprehensive maintenance management procedures which include elements such as:
- Clear definition of the management process and maintenance strategies
- CMMS management equipment classification and risk based analysis
- Health and safety policies
- Maintenance and repair operations (MRO) management
- Project management of equipment modifications and improvements
- Quality oversight and client specific requirements
- GMP considerations
- Maintenance assessments
- Equipment documentation and change control
- Equipment importance level assessments the corresponding failure-based risk assessments.
- Supplier information alignment (paperless)
- Develop equipment specific preventative maintenance procedures based on risk-based analysis, industry experience and vendor recommendations
- Develop new and/or update equipment operating procedures to cover maintenance frequency of new and existing assets.
- Define pressure vessel safety requirements, relief device design, and specification and maintenance
- Develop Reliability Centered Maintenance (RCM) programs and the associated roadmaps and action plans to deploy programs across a facility/company.
- Develop and implement cost/waste/energy reduction opportunities for equipment and facilities
- BS in Engineering, Science or equivalent technical degree.
- 8-10 years’ experience in a regulated, manufacturing environment within the biotechnology, pharmaceutical, gene therapy, cell therapy or medical device industry.
- Maintenance Strategies and Management
- Facilities and Engineering Organizational Structure
- Computerized Maintenance Management Systems
- Cost Management
- Facility Work Planning and Control
- Failure Analysis and Continuous Improvement
- Maintenance and Repair Operations and Management
- Data Management, Integrity and Standards
- Equipment design documentation (URS, FS, DS and other engineering specifications)
- General knowledge of Pharmaceutical Quality Management Systems (Change Control, Non-Conformances, Requalification, etc.)
- Process Excellence 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
- Ability to forecast and report project status to management
- Strong working knowledge of FDA and cGMP regulations and documentation practices.
- Strong working knowledge of ISO, ISPE, ICH industry guidance
- Proficient in Microsoft Word, Excel, PowerPoint.
- Working for multiple clients throughout the region.