Validation Engineer

Location: San Diego Consulting
Department: Azzur San Diego, 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.


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:

  • Customer service/client relations
  • Communication proficiency
  • Attention to detail
  • Can work productively independently with minor supervision
  • Self-motivated, flexible, dependable, and available
  • Excellent organizational and time management skills
Essential Duties and Responsibilities

  • Generates and executes life cycle documentation (FAT, SAT, IOQ, PQ) for cleaning, shipping, facilities, utilities, systems, equipment and processes for (re)qualification/(re)verification.
  • Reviews, advises on and contributes to change control documents. Provides sound validation/verification assessments.
  • Writes, reviews and revises a variety of Installation, Operation and Performance qualification/verification related documents, including any of all of the following: SOPs, validation/verification master plans, guidelines and execution plans, automation, engineering design, commissioning, qualification or other technical documents, user requirement specifications (URS), functional requirement specifications (FRS), detailed design specifications, factory acceptance test documents (FAT), verification protocols, and/or commissioning test procedures.
  • Writes reports to summarize validation/verification/commissioning and/or revalidation/verification/commissioning activities.
  • Writes procedures, investigations, protocols, reports change controls, etc. to support the Maintenance and Engineering departments.
  • Develops Validation Plans for small to medium size validation projects, qualification and validation of equipment, facilities, utilities, as well as cleaning, sterilization, and manufacturing processes.
  • Writes, and executes protocols, resolves deviations/ discrepancies,
    reviews and analyzes study data, writes summary reports.
  • Initiates and performs investigations to close out deviations. Ensures corrective actions are resolved in a timely manner. Supports the resolution of regulatory observations or manufacturing site issues.
  • Performs P&ID Walkdowns. Performs Thermal mapping of temperature controlled chambers, warehouses, and SIP processes.
  • Provides assistance with project management for commissioning,
    qualification of new engineering systems. 
  • May assist in providing training.

Qualifications

  • Bachelors Degree in engineering, science, or equivalent technical degree or Masters Degree in engineering, science, or equivalent technical degree.
  • 6-9 years experience in validation services in a regulated, manufacturing environment within the biotechnology, pharmaceutical, or medical device industry.
  • Experience in executing protocols including systems such as Process Validation, utilities, manufacturing equipment and basic knowledge of laboratory validation.
  • Strong knowledge of FDA and cGMP regulations and documentation practices.
  • Ability to read and interpret Piping and Instrument Diagrams (P&IDs), and electrical diagrams.
  • Ability to interpret and carry out instructions furnished in written, oral, diagram, mathematical, or schedule form.
  • Proficient in Microsoft Word, Excel, and PowerPoint.
  •  Experience with temperature mapping.
  • Experience with many aspects of validation


Perks of Working at Azzur

  • Medical, Dental and Vision
  • Competitive 401K plan
  • Volunteer Paid Time Off
  • Flexible Paid Vacation Time
  • Employee Recognition Program
  • Diversity and Inclusion Initiatives
  • Training and Mentorship Opportunities

Find us on social media

Instagram for our California regions: Azzur_LA, Azzur_SD and Azzur_SF

View our culture video in Youtube: https://www.youtube.com/watch?v=GPNjmsDu0LY

Azzur Group is an equal opportunity employer and promotes diverse cultures, ethnicities, gender, and ages 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.





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