Validation Engineer

Company: Kelly Services
Location: Durham
Posted on: November 22, 2021

Job Description:

**Quality/Validation Engineer- Durham, NC- Direct Hire**
**Positions Summary**
This individual supports all QA activities related to Facility Engineering and Validation in a contract manufacturing organization (CMO) setting. Responsibilities include the review and approval of GMP documentation, resulting in timely QA oversight of equipment, computer system, utility, and facility qualification/validation activities. This individual provides quality oversight of facility upgrades and expansions and is responsible for managing the change control system.
**Position Responsibilities:**
+ Provide quality oversight of Validation activities supporting both clinical and commercial operations in a contract manufacturing organization (CMO) setting.
+ Works directly with Validation Engineering and the CSV team to review and approve GMP documentation developed to support the delivery of key capital projects and facilitate the ongoing lifecycle management defined by the Validation program.
+ Provides general QA support and compliance guidance for Facilities Engineering, Validation, Metrology, CSV, and IT departments, which includes review and approval of Deviation Investigations, CAPAs, Change Controls Calibration Alert Notifications, periodic reviews, procedures, etc.
+ In conjunction with Validation functional areas, develops and manages all validation policies, procedures, and protocols.
**Position Requirements:**
+ BS and 8+ year experience or MS and 5+ years experience in a QA cGMP regulated environment within Biopharmaceuticals or equivalent.
+ Experience in a QA role supporting validation and change control is required.
+ Knowledge of US, EU and cGMP guidelines is required
\#TJP2021_SPEC
**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.
**Why Kelly** **--** **?**
Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly-- Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, we're here every step of the way to find your dream engineering job.
**About Kelly** **--**
At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.
Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.

Keywords: Kelly Services, Durham , Validation Engineer, Engineering , Durham, North Carolina