Department: Azzur Consulting LLC
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 libraries and become a mentor for others.
- 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, 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 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.
- Prepare engineering documents and operational SOPs pertaining to facility and manufacturing processes and equipment.
- Experience in designing, commissioning, and supporting validation activities regarding the infrastructure and equipment of buildings and manufacturing line.
- Have experience in startup operation/ongoing maintenance, with focus on “cGMP Compliance” and safety.
- 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.
- Responsible for operation and overall reliability of the facility and critical utilities.
- 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.
- Experienced in performing 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.
- Provides technical engineering support for the following:
- Supervision over facilities and critical utilities improvement projects
- cGMP and GxP compliance assessment and verification
- Small project construction management activities.
- Problem solving and remediation.
- Project engineering, including design, budget preparation, scheduling, and execution.
- Support equipment commissioning and qualification activities.
- Execute maintenance and reliability assessment and improvement programs.
- Bachelor's degree in chemical, mechanical, electrical, or industrial engineering. Advanced degree a plus.
- At least 4-6 years of experience as facilities engineer/manufacturing engineer/process 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.
- Knowledge of life science industry manufacturing systems, including bioreactors, media/buffer mixing and distributing system, filtration system, chromatography, TFF skids, UFDF skids, freeze/thaw operation, 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)