Department: Azzur of CA, LLC
Azzur is a GxP compliance and consulting organization dedicated to providing high quality, expertly backed, assistance that drives life science companies to success.
No matter where you are in the product development lifecycle, Azzur is here to help you start, scale, and sustain your business. From pre-clinical manufacturing to process design and process performance qualification, Azzur Group works hand-in-hand with the world's most renowned manufactures to employ risk-based and phase appropriate GxP solutions.
With a national network of engineers and consultants, we offer comprehensive quality assurance and regulatory compliance and validation services specifically geared for the complexities of life science.
We are seeking highly motivated individuals that have the desire to learn, are able to adapt to the ever-changing life sciences field and are flexible to work on various projects throughout the Southern California region all while exuding Azzur’s core values: Put Others First, Courage to Take Action, Take Personal Responsibility and Have Fun!
We aim to serve our clients, create a healthy and fun work environment and assist with professional growth for each individual through customized career development plans. As a consultant working on multiple cross functional projects, you will be able to quickly garner a wide range of skills and areas of expertise that will propel your career progression.
If 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
- Willing to work hands on with multiple clients throughout Southern California
- 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
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.
- Improve facility engineering management and procedures and recruit, train, and develop maintenance and engineering staff for startup and ongoing maintenance troubleshooting, repairs, and corrective and preventive maintenance work orders.
- Responsible for planning, implementing, and maintaining the infrastructure and equipment of buildings and facilities equipment.
- Define organization, staffing, and startup operation/ongoing maintenance, with focus on “cGMP Compliance” and safety. Develop skill set assessment and improvement process including training and career development.
- Analyze and improve the maintenance and engineering shift structure including the optimization of shift durations and schedules.
- Perform analyses of operational processes, resource allocation, energy use, and safety processes, and recommend and implement improvements.
- Ensure all critical and plant utilities comply with internal standards and external regulatory requirements. Responsible for the content of all internal SOPs and ensure department compliance with training requirements.
- Enable the daily operations of the system(s) and responsible to assure the consistent application of the established policies and procedures across the entire site footprint.
- Implement process improvements to gain efficiencies in terms of equipment uptime and reliability.
- Train and establish discipline utilizing Root Cause Problem Solve tools to mitigate equipment downtime.
- Implement an asset life cycle management program with a culture of continuous improvement built in to the process.
- Bachelor's degree in chemical, mechanical, electrical, or industrial engineering. Advanced degree a plus.
- 7-10 years of experience as facilities engineer or in a similar role in a regulated, manufacturing environment within the biotechnology, pharmaceutical, gene therapy, cell therapy or biotechnology industry.
- Experience with CMMS Systems (SAP, Maximo, Master Control, Blue Mountain, Etc), and MS Office and AutoCAD.
- Experience with safety devices in terms of installation and maintenance.
- Knowledge of the building process, engineering, and construction principles.
- Knowledge of Inventory Management fundamentals for critical spares program, bill of materials, consumables, Etc.
- Knowledge of Critical Utility Systems in the life science industry. Including HVAC, Water, Gases, Liquid Nitrogen, Tower Water, Heating Hot Water, Refrigerated Water, Etc.
- Demonstrated ability to function effectively in fluid, fast-paced situations, with the personal leadership to influence and positively motivate self and peers.
- Strong organizational, communication, and interpersonal skills
- Project management skills.
- Experience in the areas of failure modes analysis (FMECA, FMEA, PHA, RCM, DMAIC)
- Medical, Dental and Vision
- Competitive 401K plan
- Flexible Paid Vacation Time
- Employee Recognition Program
- Diversity and Inclusion Initiatives
- Training and Mentorship Opportunities
Learn more about who we are and what makes us great here: https://www.youtube.com/watch?v=9VmKkBLkoFQ