Department: Azzur of CA, LLC
Job Description
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 Qualities:
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
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.
- Manage all aspects of the Process Engineering function from concept to final qualification and system release, including project updates and maintaining process equipment project schedules.
- Develop conceptual process designs and the corresponding process flow diagrams and piping/instrumentation diagrams.
- Develop design documents for the process equipment in accordance with Good Engineering Practice, i.e. URS, FRS, HDS, SDS, CS, etc.
- Develop process equipment procurement specifications and data sheets based on approved design documents.
- Prepare detailed bid evaluations for procurement of the process equipment and system construction packages.
- Review vendor equipment drawings and specifications and drive the system integration with the site utilities and computerized systems (SCADA).
- Review and comment on detailed design packages from A&E firms.
- Prepare automation design documents in accordance with the FS, SDS, and other applicable references.
- Develop process maps including people-material flows.
- Create mapping of the critical quality attributes against the process requirements and identify the critical process parameters.
- Perform PHA, FMEA, FMECA and other applicable risk assessments against the proposed process to determine acceptable control strategies.
- Generate system impact assessments and critical component assessments including system boundary maps.
- Lead multi-functional design reviews, identify gaps to the original design documents and update design documents as required to remediate gaps.
- Prepare change control documents and justifications as required.
- Capable of preparing commissioning and qualification documents for process equipment and the associated manufacturing lines.
- Assist in writing and executing process validation documents.
Qualifications
- Education: BS/BA degree required. An advanced degree in Chemical, Mechanical or Biomedical Engineering is a plus.
- 8-10 years’ experience in a regulated, manufacturing environment within the biotechnology, pharmaceutical or medical device industry. 5 years of direct process engineering experience is a plus.
- Experienced in the areas of Process Equipment Design, specifically with isolators, autoclaves, parts washers and fill-finish equipment. Demonstrates a soldi understanding of cleaning validation and sterilization.
- 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.
- Working for multiple clients throughout the region.
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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