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Senior Validation Specialist

Location: Branchburg, NJ

Job Description

Azzur Group is looking for Validation Specialist in the Branchburg, NJ area for consulting projects. This is great opportunity expedite your career growth through exposure to projects across multiple client sites and functions! If you can deliver high-quality customer service and results while engaging in our fun and energetic culture; we want to hear from you!



Qualifications

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.

Specifications

  • 5-8 years in the CQV / CSV environment including writing and executing IQ, OQ, and PQ protocols in support for the commissioning and qualification of GLP / GMP laboratory equipment.
  • At least 5-7 years experience with the successful validation, qualification, or requalification of laboratory and / or manufacturing equipment in a cGxP regulated environment. Examples of equipment are CTUs, GMP / Non – GMP Warehouse environments, biosafety cabinets, bioreactors, filtration, Air Handling Units, Electric Systems, Process Gases, UPS System, Natural Gas Systems, Compressed Air Systems, Chillers, Boilers, BAS (GMP / Non-GMP), Fume Hoods,and QC (quality control) equipment
  • Write deviations associated with protocol execution and work with team of engineers to resolve.
  • Author qualification reports for executed protocols.
  • Write or revise existing protocols as needed based on new and / or previously executed equipment.
  • Work with Facilities, Engineering, and QC personnel to obtain documentation necessary for equipment release.
  • Work with senior Azzur Engineers on site for guidance on project and protocol execution.

EDUCATION:

  • BS Engineering or related discipline

Benefits

Fulltime Employment with Azzur can offer you:

  • Flexible PTO
  • Training and Development Opportunities
  • 401(k) match
  • Bonus Eligibility
  • Medical Benefits
  • Paid Holidays
  • Company provided laptop

Who we are:

Azzur Group is a professional service company providing biotechnology and pharmaceutical clients with engineering, validation, CSV-IT, technical, and consulting services. At Azzur, we look to hire full-time consultants who deliver results to our valued clients while providing you the opportunity to develop and grow in the industry through diverse project assignments. Using our 4 Core Values as guidance, we expect all Azzur Employees to:

  • Put Others First,
  • Have the Courage to Take Action,
  • Take Personal Responsibility, and
  • Have Fun!
 

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.



Apply Now
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