Validation Engineer

Validation Engineer

This role is responsible for providing advanced technical and engineering support to operations for equipment/system initial validation and requalification. The role involves participating in equipment improvement teams to enhance compliance and performance of plant systems, while considering regulatory requirements for change control. Coordination of HEPA filter integrity/velocity testing and critical air airflow pattern testing is also required. A comprehensive understanding of cGMPs is essential, and certification to enter controlled areas of the plant will be necessary. The role provides direction through direct or indirect supervision to validation team members and contractors.

Responsibilities:

• Schedule and participate in equipment requalifications per Standard Operating Procedures (SOPs). Coordinate and communicate all testing with affected functional groups, where applicable, and evaluate test results.
• Execute validation studies or act as Project Manager for equipment including protocol preparation, scheduling, execution, and final report preparation.
• Present results to Regulatory Agency when necessary.
• Program, lead, and/or operate department instruments to perform controlled temperature/humidity chamber qualifications.
• Develop and improve validations programs to remain current with cGMPs and industry standards.
• Schedule and execute HEPA Filter and critical area testing per SOP, and airflow pattern testing.
• Represent the Validation department in teams assembled to specify, install, validate, troubleshoot, and maintain systems and equipment.
• Conduct Validation deviations and/or participate in deviation investigations to identify root causes and define corrective and/or preventative actions (CA/PA).
• Mentor lower-level engineers, professionals, and technician personnel.

Essential Skills:

• Experience with validation protocols, process validation, and equipment validation.
• Proficiency in generating reports, deviations, or other technical documents.
• Experience with Installation, Operational, and Performance Qualifications protocol generation and execution.
• PC literacy with competency in standard office applications (Word, Excel, PowerPoint, Project, Access).
• Comprehensive knowledge and understanding of cGMPs, industry guidance, and aseptic techniques.
• Understanding of 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.

Additional Skills & Qualifications:

• Experience in the pharmaceutical industry and equipment validation engineering.

Work Environment:

The work environment requires entering controlled plant areas, necessitating certification to comply with cGMPs. The role involves using department instruments such as temperature/humidity dataloggers, smoke generators, photometers, and velocity meters to conduct various tests and evaluations.

Job Type & Location:

This is a Contract position based out of Wilson, NC.

Pay and Benefits:

The pay range for this position is $50.00 - $60.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. 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)

Workplace Type:

This is a fully onsite position in Wilson,NC.

Application Deadline:

This position is anticipated to close on Jan 23, 2026.