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Senior Validation Engineer(Consultant)

Location: Waltham, MA

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 four core values; 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:

  • 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.

 

● Development and editing of technical documentation including:

- Standard Operating Procedures

- User Requirements and Design Specifications

-Commissioning and Qualification Protocols

● Development of project plans, as appropriate

● Execution of validation test procedures

● CAPA and Change Management

● Thermal mapping of temperature controlled chambers, warehouses, and SIP processes

● Technical presentations

● Technical report writing

● Data Analysis

● P&ID walkdowns

● Performs/executes/validation/verification studies(FAT,SAT, IQ,OQ,PQ) for cleaning, shipping, equipment, systems, utilities, and processes for qualification/verification and/or re-qualification/re-verification

 

Qualifications

  • BS in Engineering, Science or equivalent technical degree.
  • 1-7+ years' experience in a regulated, manufacturing environment within the biotechnology or pharmaceutical 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,Requalification, 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.
  • Is able and open to working for multiple clients throughout region.