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:
- 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, gene therapy, cell therapy and biotechnology industry
- Willing to work hands on, assist with building client programs and become a mentor for others.
- Understands worldwide life science regulations and phase appropriate applications
- Draws insights from projects and supplemental research to help drive program and process improvements
- Ensures activities are efficient, optimized, and client-centric.
- Highly motivated and organized, solutions-oriented leader
- Curious, Innovative 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 level of knowledge expected should be commensurate with level of incoming experience.
This position is responsible for managing the configuration and support of the Central Maintenance Management System (CMMS). Responsible for developing, implementing, and institutionalizing maintenance KPIs, training and development plans for technical resources, root cause problem solving, preventive maintenance and metrology disciplines, predictive maintenance, parts room inventory management, Bill of Materials, Critical Spares, etc. The position is particularly focused around enabling Reliability Engineering to foster continuous improvement. This position provides the policies and procedures around critical data needed to track Key Performance Indicators and analyze team performance, comparing against targets and benchmarks. The incumbent enables the daily operations of the system(s) and is responsible to assure the consistent application of the established policies and procedures across the entire footprint.
The position will report to the Director of Engineering, Los Angeles. Define and develop comprehensive asset reliability policies comprised of maintenance processes that will be utilized across the production facilities. Manage implementation of CMMS and relevant applications across the organization in close coordination with IT. Institutionalize the use of CMMS to track maintenance activities within production facilities. Define and track Maintenance KPIs and follow through with the local teams to improve performance. Responsible for configurations changes to the CMMS as needed to align with the business needs. Implement preventive and predictive maintenance practices to improve equipment reliability. Establish training and development programs that will improve the leadership and technical skills of both salaried and hourly maintenance and calibration resources at the production facilities. Create process documentation providing training on system functionality and orientation for internal customers. Train and establish discipline around utilizing Root Cause Problem Solve tools to mitigate equipment downtime. Implement best practices for parts room inventory management to reduce inventory value and decrease overhead costs based on optimized consumption.
Who are we looking for? Required Competencies, Education, and Experience:
- Bachelor degree required. Engineering preferred. Reliability Certifications a plus.
- Expert knowledge of reliability principles.
- Failure Modes Effects Criticality Analysis (Risk, Rank, Filter)
- Asset Hierarchy
- Maintenance Master Data
- Cause, Problem, Remedy Codes
- Failure and Betterment Analysis
- Expert knowledge of CMMS functionality and associated applications.
- Experience in project management and leading multidisciplinary team
- Minimum of 5 year experience in manufacturing and maintenance environment
- Work with Reliability Team to perform analyses of assets.
- Establishes Cause, Remedy and Failure Codes for GMP equipment
- Ensure adherence to specifications.
- Develops Maintenance and Calibration procedures encompassing proper preventive maintenance and calibration strategies based on asset criticality.
- Update existing and creations of new Standard Operating Procedures to cover rationale for maintenance frequency of new and existing assets.
- Experience with safety devices in terms of installation and maintenance.
- Execute Reliability Centered Maintenance (RCM) or other improvement projects in assigned area.
- Demonstrated ability to function effectively in fluid, fast-paced situations, with the personal leadership to influence and positively motivate self and peers.
- Support the implementation of predictive/condition-based maintenance across the facility.
- Identify cost/waste/energy reduction opportunities.
- BS in Engineering, Science or equivalent technical degree.
- 5-10 years’ experience in a regulated, manufacturing environment within the biotechnology, pharmaceutical, gene therapy, cell therapy or biotechnology industry.
- Experience in the areas of failure modes analysis (FMECA, FMEA, PHA, RCM, DMAIC)
- Experience in the areas of design documentation (URS, FS, DS and other engineering specifications), Quality Systems (Change Control, Non-Conformances, etc).
- Experience in the areas of Process Excellence Methodologies (Six-Sigma, Lean, etc.).
- Experience in the areas of Root Cause Analysis (5M, 5Why, Fault Tree Analysis, 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.
- Auto CAD a plus