Validation Engineer/Specialist

Location: Raleigh, NC

Job Description

Position Description:

Write, review, execute and write final reports for CQV activities as assigned.

Support all types of CQV activities including Commissioning, Qualification, Validation, Computer Systems Validation CSV), Cleaning Validation (CV), Process Validation (PV) and more.  Potential projects include Facilities, utilities, Systems and Equipment.

Write and review documentation to support validation activities including Validation plans, risk assessments, mitigation strategies, investigations of non-conformances, SOPs, Work Instructions, batch records, and others as needed.

 Travel as required to support clients locally and those out of our immediate area.

Position Requirements:

Bachelor’s degree (BS) in Science, chemistry, Engineering or a related field is required.

Must have at least 2 years of experience in the life science industry (Pharmaceutical, BioPharmaceutical, Medical Device, Combination, etc.)

Clear and demonstrated understanding of cGMPs and GDPs

Strong technical writing, communicating abilities and attention to detail

Proficient computer skills and MS office skills including word processing, spreadsheet and database software.

Ability to interpret engineering drawings.

Demonstrated experience and knowledge of qualifying changes to validated systems, processes and equipment.

Knowledge of basic statistics and calculations is expected.

Capable of working independently or as part of a team

Must pass pre-employment screens and background.

Physical Requirements

Must be able to stand and walk for up to 8 – 12 hours

Must be able to lift up to 50 lbs

Must have appropriate vision (may be corrected) to perform detailed quality inspection in support of validation activities.
 

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, 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!