Validation Consultant III

Location: Raleigh, NC
Department: Azzur of North Carolina, 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.

Experience:


The Validation Engineer will provide technical leadership for the Azzur's client site. Candidate will be responsible for site validation, qualification performance, and document maintenance, to meet GMP/GDP compliance. The focus of this position is to support the site operations and maintain validation compliance, as well as supporting technical investigations. Responsible for the site Validation Master Plan and Shipping Validation Master Plan. Responsibilities and assignments will be received in task and objective orientated terms, supported by company Standard Operating Procedures (SOP’s). Provides support to Operations, Quality, and Facilities departments. Interprets and executes policies and procedures that typically affect other organizational units. The engineer will recommend modifications to operating policies, as needed.

In-depth experience in most of the following areas:

 Process, thermal, shipping, and equipment qualifications including writing and executing protocols.
 Perform and direct the validation activities including start up protocols, technical reports, temperature profiles, specifications, risk assessments, and thermal studies.
 Write and maintain Validation site specific procedures in compliance with Corporate Policies and Standards.
 System / Instrument Calibration and Maintenance.
 Support implementation of validated system change requests and resolution of process deviations through technical knowledge, and use of root cause investigation tools, execution of supporting validation studies, and documentation review and approval.
 Perform and direct daily operations of validation services.
 Work with validation and metrology contractors when required.
 Project management experience. Creating Project Charters, Plans and driving projects to completion. Maintain Master Project plan and schedule for assigned projects for frequent reporting to colleagues and management.
 Performance and completion of periodic reviews as required.
 Generate individual and more complex reports utilizing various resources.
 Knowledge of facility validation and strong technical writing abilities.
 Provide leadership to other site groups, with focus on verbal and written communication, teamwork, and problem solving. 


 Bachelor’s degree in science, engineering or related field.
 5–10 years validation experience in pharmaceutical/biological manufacturing/distribution.
 FDA, cGMP, European, Regulations.
 Preferred experience with PDA and ISPE Guidelines (to include Good Distribution Practices)
 Ability to read, analyzes, and interprets general business periodicals, professional journals, technical procedures, and governmental regulations.
 Must have the ability to write technical reports, business correspondence, and procedural manuals/documents.
 Ability to work with mathematical concepts such as probability, statistical inference, and have fundamentals of plane, solid geometry, and trigonometry  Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations
 Ability to solve problems and deal with a variety of concrete variables in situations where only limited standardization exists
 Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule format
 Microsoft Office applications including Outlook, Teams, SharePoint and Visio. Electronic QMSsystems for Document Management, Change Control, Corrective Actions, etc..
 cGMP operations experience

Do What You Love

At Azzur, we look for talented individuals who take pride in the work they do. We foster employee growth by encouraging our employees to focus on doing what they love and what they do best.

Azzur is a GxP compliance and consulting organization dedicated to providing high quality, expertly backed, assistance that drives life science companies to success.  We are seeking highly motivated and talented individuals to join our incredible team of skilled problem solvers.  Qualified candidates must have a desire to learn, apply, engage, and adapt in the ever-changing healthcare field while simultaneously and organically exuding Azzur’s core values:

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

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