Validation Engineer II

About the Role

We are seeking a Validation Engineer II to lead the implementation of new systems through the validation process and ensure all validation deliverables and regulations have been met. The Validation Engineer II will build and execute a periodic review program for our validated systems.

Schedule

8:00 AM – 5:00 PM; Monday to Friday; On-site

Location

13203 Murphy Road Suite 100, Stafford, TX 77477

Qualifications

• Bachelor’s degree in Science, Engineering or a related major (Biotechnology or related preferred).
• 5+ years experience in the pharmaceutical or biotech industry.

Preferred Qualifications

• Experience working within a GxP regulated manufacturing or laboratory environment.
• Understanding of good documentation practices and data integrity principles.
• Demonstrated understanding of 21 CFR Part 11, 21 CFR Part 210, 21 CFR Part 211, GAMP 5, and USP.
• Experience in writing and reviewing deviations and CAPAs, investigations leading to change controls.

Responsibilities

• Draft validation documents including validation plans, user requirements specification (URS), risk assessments, configuration specification documents, installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ) protocols, trace matrix, and summary reports.
• Execute test scripts from IQ/OQ/PQ protocols using good documentation practices and provide appropriate supporting evidence.
• Create and manage project timelines and deliverables.
• Monitor and review Quality Management Systems (CAPA, Change Controls, Deviations) and Batch Record Issuance procedures to ensure and maintain compliance with corporate and regulatory agency requirements.
• Contribute to the writing, coordination, review, and approval of Quality Events when needed.
• Coordinate, support, and investigate Corrective and Preventive Actions (CAPAs).
• Draft SOPs and work instructions for system operation, maintenance, and cleaning.
• Assist in Change Control process from initiation, revision of documents and processes up to training and implementation.
• Assist in preparing QMS training materials and perform training as required.
• Support cross-functional groups for QMS functions and projects not limited to Computer Systems Validation, Equipment Maintenance, Manufacturing, Quality Control, New Hire Onboarding, external and internal audits as needed.
• Perform periodic reviews, requalifications, and remediations for systems throughout the system lifecycle.

Benefits

• Competitive rates for Health, Dental, and Vision Insurance.
• 4 weeks of vacation, granted up front each year and prorated for first and last year of employment.
• 12 company paid holidays.
• 7 days of sick time.
• 100% employer-paid life insurance up to 1x annual salary, up to $100,000.
• 100% employer-paid short- and long-term disability coverage.
• 401(k) with immediate eligibility and company match (100% match up to 3% of base salary for the first two years, 4% for years 2-3, and up to 5% from the fourth year onward).
• Partially paid parental leave for eligible employees.
• Additional voluntary employee-paid benefits and services, including accident, hospital indemnity, critical illness insurance, identity theft protection, and pet insurance.