Job Title: Validation Engineer
Job Description

Responsibilities:• Work closely and partner with the network of manufacturing, development and quality partners and has accountability for firm's interest in the quality and compliance aspect of these partnerships. Update management regarding status of deliverables and identify critical activities/risks.• Ensure that appropriate compliance activities are maintained during operation to support cGMP compliance (calibration, validation, environmental monitoring).• Review and approve Validation documents, plans, protocols, and reports used in support of Petersburg site activities to ensure compliance (e.g. 21 CFR Part 210-211).• Attend onsite visits to contractors as well as equipment manufacturers to support validation activities.• Support system implementations of GMP software including eDMS, LMS, eQMS. Serve as the subject matter expert for qualification, training and ongoing system administration of these systems.• Maintain computerized systems that are compliant with corporate requirements and good business practices, includes participation on the change control committee.• Review and approve System Life Cycle Deliverables and activities for computerized systems ensuring that corporate procedures, and Regulatory requirements are followed (e.g. 21 CFR Part 11, Annex 11, etc.).• Provide a service to the Business stakeholders (end users) by verifying systems meet agreed upon requirements in a compliant manner, including communication to the Business stakeholders regarding system updates/changes.• Ensure that appropriate and complete documentation is produced to support system validation activities for GxP systems.• Assist in tracking quality commitments and change control activities to ensure manufacturing changes are supported in accordance with regulatory requirements.• Reviewer/Approver for quality owned SOPs within the electronic documentation management system.

Hard Skillsqualityvalidation engineerFDAJob Type

This is a Contract-to-Hire position with a duration of 9 Month(s).

Work Site

This is a fully on-site position in Richmond, Virginia.

Work Environment

3 total people within Quality department. Expected to see significant growth

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.