Principal Validation Engineer

Location: Worcester, MA
Department: Azzur Worcester, LLC

Job Description

From Discovery to Delivery™, Azzur Group provides the life science community with full lifecycle solutions for all their GxP needs. From Azzur Cleanrooms on Demand™ facilities, to labs, training centers, and consulting and advisory offices across the nation, Azzur helps organizations start, scale, and sustain their enterprises. With four decades of service to the industry, we've become a trusted partner to leading pharmaceutical, biotechnology, medical device, and healthcare companies, as well as their supply chain.

Requirements:

·
Generate detailed timelines for programs, ensure they are executable and drive execution efforts to deliver on time.
· Lead data review meetings for the programs and ensure key decision points are identified and executed upon.
· Manage program risks and ensure that mitigation strategies are in place.
· Perform gap analysis to bring different project stakeholders’ alignment and ensure identification of gaps and driving the risk mitigation arising from them to closure.
· Develop SOPs and procedures to ensure consistent application of the requirements and strategies.
· Provide technical guidance, establishes project priorities, and schedules activities to ensure timelines and milestones are met;
· Generate, review, and approve validation documents to support cleaning validation activities.
· Communicate effectively and promptly at all levels of the organization, supporting department objectives and management decisions.

Ideal Performance Qualifications:
 Bachelor’s degree in Mechanical, Chemical or Electrical Engineering or equivalent.
 10+ years of experience in validation services in a regulated, manufacturing environment within the biotechnology, pharmaceutical, and/or medical device industry is required.
 Candidates should include a good mix of mid to high experience levels with proficiency in equipment, computer, process and cleaning validation.
 The ability to perform commissioning and qualification activities for implementation of new facility/utility/equipment systems and manufacturing processes for pharmaceutical, medical device, and/or biologics production in a regulated environment (FDA, ISO, DEA, OSHA, etc.)
 Strong experience in developing, reviewing, and submitting for final approval 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, deviations, user requirement specifications (URS), functional requirement specifications (FRS), detailed design specifications, factory acceptance test documents (FAT), verification protocols, and/or commissioning test procedures with minimal guidance and supervision.
 At least 5 years of experience with the successful validation, qualification, or requalification of laboratory and/or manufacturing equipment in a cGxP regulated environment. Examples of equipment are incubators, plate readers, refrigerators/freezers, mixers, biosafety cabinets, bioreactors, filtration, and QC (quality control) equipment.
 Confidence to work with test equipment and ability to use test equipment with limited to no supervision (i.e. Kaye Validators, Valprobes, Veriteq Dataloggers, SensiTech Dataloggers, Fluke Multimeters, etc.).
 Self-motivated and demonstrated ability to work with multi-functional team to meet goals and achieve results in a dynamic and fast paced environment.

 The ability to execute independently with minimal oversight on technical documentation in accordance with cGxP regulations.
 Exhibits competency with computer skills required to support data collection/analysis, comparative and statistical evaluations, and professional-level reports/presentations including graphs and charts.
 Must be willing to travel to client sites across the region (i.e., a valid driver’s license and transportation.)
 The ability to adapt and transform technical knowledge into actionable activities.
 Strategic thinker with strong analytical skills who can translate client needs into actionable value-added projects/results.
 Strong and effective communication skills with ability to quickly elevate issues to the appropriate decision makers (both client management and Azzur management).

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


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 4 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:

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   
Azzur Group is an equal opportunity employer and promotes a diverse culture 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.  All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status. 


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