Validation Engineer (Consultant)

Location: Los Angeles, CA
Department: Azzur of CA, LLC

Job Description

About Azzur

Our employees are fueled by an entrepreneurial spirit and the desire to make a difference in the lives of our customers, coworkers and our partners. If you’re ready to put in the work, take personal responsibility and test the limits of what’s possible, we’re ready to provide the reward.

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 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.

  • Support equipment installation and process implementation of new equipment /processes relevant to manufacturing, packaging and utility systems in a regulated environment (FDA, DEA, OSHA, etc.) and strictly follow procedures.
  • Basic understanding of pharmaceutical manufacturing and packaging equipment and processes.
  • Basic understanding of the basic principles of technology transfer, process investigations, scale-up, process validation, and optimization of pharmaceutical processes spanning the entire product life-cycle.
  • Clearly and accurately document activities across the validation life cycle as requested.
  • Assist with developing specifications as needed for equipment / systems.
  • Work closely with equipment vendors to ensure thorough and accurate documentation is gathered during the installation and start up processes.
  • Provide input to test parameters, process parameters, validation documentation
  • Develop critical parameters needed for follow up validation testing of equipment and processes.
  • Perform basic to high-level mathematical calculations to support process development
  • Monitor manufacturing and packaging processes during initial production run to assess any technical process issues.
  • Assist in writing qualification (IQ,OQ,PQ, PPQ), cleaning validation and technical improvement reports.
  • Provide input to Master Batch Records (MBRs). (equipment, critical process parameters, in-process tests, etc.)
  • Basic understanding of safety policies.
  • Self-motivated and able to follow instructions from project lead(s) and the ability to work with multi-functional team to meet goals and achieve results.
  • Basic computer skills. Collect data, conduct comparative and statistical evaluations and present it in a professional manner including graphs and charts.
  • Ability to interact with clients on a regular basis.

Qualifications

  • ·BS in Engineering, Science or equivalent technical degree.
  • 3-5+ years’ experience in a regulated, manufacturing environment within the biotechnology, pharmaceutical or medical device industry.
  • Experience in the areas of design documentation (URS, FS, DS and other engineering specifications) Validation (IQ, OQ, PQ, PV, CV, CSV, etc.), Quality Systems (Change Control, Non-Conformances, Re qualification, etc), and Process Excellence Methodologies (Six-Sigma, Lean, 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.
  • Working for multiple clients through out the region.


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