Validation Engineer

Validation Engineer Entegee - 3.7 Westfield, IN Job Details Full-time $80,000 - $92,000 a year 1 day ago Benefits Commuter assistance Disability insurance Health insurance Dental insurance 401(k) Vision insurance Life insurance Qualifications Quality control corrective actions USP standards Content creation for technical audiences Technical documentation ISO standards Mechanical system commissioning projects Technical writing within manufacturing Production deviation management Corrective and preventive actions (CAPA) Manufacturing facility Data integrity and documentation Production validation processes Quality control documentation Pharmaceutical company experience Packaging System testing Quality assurance within pharmaceutical industry Regulatory/legal compliance standards in production Biomedical regulatory compliance Managing projects Investigating compliance violations Sterile products production Commissioning phase involvement Factory experience Risk assessment implementation Cleaning and sanitation quality assurance FDA regulations Pharmaceutical manufacturing facility experience Full Job Description Overview We are seeking a Validation Engineer to support validation and qualification activities for sterile manufacturing equipment, utilities, facilities, and processes within a regulated radiopharmaceutical manufacturing environment. This role is responsible for ensuring compliance with cGMP requirements and applicable regulatory standards through the execution of validation lifecycle activities, including commissioning support, qualification, process validation, cleaning validation, and ongoing revalidation efforts. The ideal candidate will have experience supporting sterile pharmaceutical manufacturing operations and possess strong technical knowledge of validation principles, regulatory compliance, and quality systems. This position requires approximately 25% travel within the United States to support validation activities across multiple manufacturing facilities. Key Responsibilities Lead and execute validation and qualification activities for manufacturing equipment, utilities, and systems Develop, review, and approve validation lifecycle documentation including Validation Master Plans (VMPs), User Requirements Specifications (URS), risk assessments, IQ/OQ/PQ protocols and reports, commissioning and qualification documentation, cleaning validation protocols and reports, temperature mapping studies, and continued process verification documentation Support qualification and validation of HVAC systems, autoclaves and sterilization equipment, fill-finish manufacturing lines, lyophilization systems, Water for Injection (WFI) systems, clean steam systems, and packaging equipment and processes Coordinate and participate in Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) Perform and document equipment, utility, and facility qualification activities Execute cleaning validation studies and support process validation initiatives Conduct risk assessments to determine validation requirements and testing strategies Investigate deviations, non-conformances, and validation-related issues and implement corrective actions Support change control activities and assess validation impact of system modifications Collaborate with Manufacturing, Engineering, Quality Assurance, Regulatory Affairs, and external vendors to ensure project success Ensure validation activities comply with applicable FDA, EU, ISO, USP, and internal quality requirements Maintain validation records and ensure inspection readiness Support internal audits, customer audits, and regulatory inspections Required Qualifications Bachelor's degree in Engineering, Life Sciences, or a related technical discipline preferred Minimum 3 years of validation experience in pharmaceutical, biotechnology, medical device, or other regulated manufacturing environments Minimum 2 years of experience supporting sterile manufacturing processes Hands-on experience with validation lifecycle activities including

IQ/OQ/PQ

execution and documentation Experience supporting FAT, SAT, commissioning, qualification, and validation projects Knowledge of cGMP regulations, FDA requirements, EU GMP guidelines, ISO standards, USP requirements, and data integrity best practices Experience managing deviations, CAPAs, change controls, and risk assessments Strong technical writing and documentation skills Ability to manage multiple projects and priorities in a fast-paced manufacturing environment Willingness and ability to travel approximately 25% within the United States Preferred Qualifications Experience in radiopharmaceutical manufacturing environments Familiarity with aseptic processing, sterile filling, and packaging operations Experience performing thermal validation and temperature mapping studies Proficiency with validation systems and tools including Kaye Validator, ValProbe, and Ellab Knowledge of commissioning and qualification methodologies for pharmaceutical facilities and utilities Experience supporting regulatory inspections and audit responses Equal Opportunity Employer/Veterans/Disabled Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State or local law; and Holiday pay upon meeting eligibility criteria.

Disclaimer:

These benefit offerings do not apply to client-recruited jobs and jobs which are direct hire to a client

GRPB Pay:

$80,000.00 - $92,000.00 per year

Benefits:

401(k) Dental insurance Health insurance People with a criminal record are encouraged to apply

Work Location:

In person