Department: Azzur of CA, 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, and biotechnology industry
- Willing to work hands on, assist with building client libraries, learn from a mentor and become a mentor for others.
- Understands worldwide regulations and phase appropriate applications
- 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 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
The Director of Controls and Automation will be responsible for ensuring that day-to-day management needs of both Azzur and its’ clients are met by providing hands on support for projects, and direction for the team of consultants. The Director will also be responsible for growing the core consulting practice, managing & developing the team of consultants and executing billable consulting work as needed.
In addition to the responsibilities listed above, the Director of Controls and Automation must have the following:
- Experienced in managing automation teams including technical development, recruitment, and retainment.
- Ability to develop new business through technical presentations and solution development. The position requires the development of client relationships, providing solutions to their automation needs.
- In depth experience with PLC and digital based control systems including hardware and software design, programming, and control system qualification.
- Experienced in creating C&Q documents from Validation Plan through Commissioning and IOQ final reports.
- Thorough knowledge of enterprise level systems including design and integration of BAS, MES, DCS, LIMS, CMMS, CCMS.
- Expert in the creation of control system design documentation including URS, FS and DS documents.
- Thorough understanding of controls system integration including network design and the associated hardware specification.
- Able to drive cross-functional scope development, execution planning, and daily operations guidance for automation related capital projects.
- Program level experience in managing automation systems in a regulatory environment with the ability to create program level guidance documents and SOPs.
- Solid experience in 21 CFR Part 11, 210 and 211 as well as Annex 11 and GAMP recommendations using a risk based approach to design, commissioning, and qualification.
- Demonstrates a solid knowledge of the control methodology including the critical components to developing sustainable control algorithms.
- S. Engineering or related discipline
- 10+ years’ experience in the Pharmaceutical or Biologics industry
- Must be results oriented with several years of hands-on experience, familiar with industry concepts, practices and procedures in a cGMP environment
- Knowledge of deviation and CAPA investigations and change control requirements
- Strong working knowledge of FDA and cGMP regulations and good documentation practices
- Excellent written and verbal communication and technical writing skills
Perks of Working at Azzur
- Medical, Dental and Vision
- Competitive 401K plan
- Wellness reimbursement program
- Volunteer Paid Time Off
- Flexible Paid Vacation Time
- Employee Recognition Program
- Diversity and Inclusion Initiatives
- Training and Mentorship Opportunities
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View our culture video in Youtube: https://www.youtube.com/watch?v=GPNjmsDu0LY