Validation Engineer

Responsibilities

• 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.
• Program, lead, and operate department instruments to perform controlled temperature/humidity chamber qualifications.
• Develop and improve validation programs to remain current with cGMPs and industry standards.
• 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.
• Conduct validation deviations and participate in deviation investigations to identify root causes and define corrective and preventative actions.
• Mentor lower-level engineers, professionals, and technician personnel.

Requirements

• Experience with validation protocols and process validation.
• Knowledge of Installation, Operational, and Performance Qualifications protocol generation and execution.
• Competency with standard office applications (Word, Excel, PowerPoint, Project, Access).
• Understanding of cGMPs, industry guidance, and aseptic techniques.
• 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.

Qualifications

A comprehensive understanding of cGMPs is essential, and the individual must become certified to enter controlled areas of the plant.

Skills

• Experience with inspection machines and pharmaceutical equipment validation.
• Engineering background with a focus on validation.

Benefits

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)

Pay and Benefits

The pay range for this position is $47.00 - $52.00/hr. 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.

About the Role

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.