Process Validation Engineer

Job Title

Validation Engineer

Warsaw, IN 46580

12+ Months (Extendable)

$30.00 – 35.00/hr on W2

• Responsible for the development, execution, and management of installation, qualification, and validation documents and protocols for process equipment
• Support a wide variety of Equipment qualifications including CNC machines
• Guide, mentor, and cross-train team members to broaden validation capabilities, including equipment and process validation
• Create change requests in windchill to support equipment moves
• Execute project plans and schedules for work activities
• Communicate (written and verbal) with appropriate personnel from other departments

• Strong knowledge of cGMP regulations, including FDA, EMA and ISO requirements
• Experience writing and executing validation protocols and reports, including IQ/OQ/PQ documentation
• Proficiency with validation of manufacturing equipment, utilities, cleaning processes and computer systems
• Good problem-solving skills through the use of quality and statistical tools
• Ability to effectively work within a cross-functional team to complete critical project tasks
• Demonstrates good written and verbal communication skills
• Strong technical writing and documentation skills
• Ability to independently develop and execute on project plans
• Demonstrated ability to take initiative and provide recommendations on process, procedure and training

• B.S. in Engineering with a minimum of 3-year experience in validation in pharmaceutical/biotech manufacturing