Validation Engineering

Job Title: Validation Engineer Job Description
This role involves providing advanced technical and engineering support for equipment and system initial validation and requalification. The engineer will be an integral part of teams focused on improving compliance and performance of plant systems, with a keen understanding of regulatory requirements for change control. The role includes coordinating HEPA filter integrity/velocity testing and critical air airflow pattern testing. A comprehensive understanding of cGMPs is essential, and the individual must become certified to enter controlled areas of the plant. The engineer will also provide direction to validation team members and contractors as necessary.
Schedule and participate in equipment requalifications according to Standard Operating Procedures (SOPs), coordinating and communicating testing with affected functional groups.
Execute validation studies, acting as a Project Manager, including protocol preparation, scheduling, execution, and final report preparation.
Present results to Regulatory Agencies when necessary.
Schedule and execute HEPA filter and critical area testing, and airflow pattern testing, using equipment such as smoke generators, photometers, and velocity meters.
Represent the Validation department in teams responsible for specifying, installing, validating, troubleshooting, and maintaining systems and equipment.
Knowledge of Installation, Operational, and Performance Qualifications protocol generation and execution.
Competency with standard office applications (Word, Excel, PowerPoint, Project, Access).
Familiarity with statistical analysis tools and methods.
Knowledge of cGMP room classifications, HEPA filter testing, and airflow pattern testing tools and techniques.
Experience in cGMP CA/PA, root cause analysis, risk assessment, and investigation tools and techniques.
Experience with inspection machines and pharmaceutical equipment validation.
Engineering background with a focus on validation.
The work environment involves working in controlled areas of the plant. The role requires wearing appropriate attire to comply with cGMP standards and may involve operating various testing instruments. Standard office applications are used frequently, and collaboration with various departments is essential.
This is a Contract position based out of Wilson, NC.
Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.
If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)
Application Deadline
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 20,000 consultants and 5,000 clients across the U.Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

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 View email address on click.appcast.io of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.