QA Validation Engineer
8a7883d088e0b78e0188e964e98602d7 · North Augusta, SC ·
- Category
- QA
- Experience
- 5+ years
QA Validation Engineer
This role is onsite at our North Augusta, South Carolina location. Relocation is required, please apply to learn more about our relocation assistance program.
Purpose and scope of the position:
The Quality Assurance Validation Engineer is responsible for providing independent Quality Assurance oversight, review, and approval of qualification and validation activities to ensure compliance with applicable cGMP, regulatory, and company requirements. This position serves as the quality representative for validation programs associated with manufacturing processes, equipment, utilities, cleaning processes, analytical test methods, and related systems. The QA Validation Engineer collaborates with cross-functional teams including Manufacturing, Engineering, Validation, Facilities, Metrology, Quality Control, and Technical Services to assess validation strategies, review technical documentation, evaluate deviations and change controls, and ensure that validation activities are scientifically sound, properly documented, and suitable to support the manufacture and testing of pharmaceutical active ingredients. The role is responsible for maintaining validation compliance throughout the lifecycle of qualified systems and validated processes while promoting quality culture, data integrity, continuous improvement, and inspection readiness across the organization.
Primary accountabilities:
• Perform Quality Assurance review and approval of validation lifecycle documentation, including Validation Master Plans (VMPs), risk assessments, protocols, reports, and periodic reviews.
• Review and approve equipment qualification documentation, including User Requirements Specifications (URS), Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Review and approve utility qualification activities and supporting documentation for systems used in manufacturing and laboratory operations, including water systems, HVAC, and other GMP utilities.
• Review and approve process validation protocols and reports for commercial API manufacturing processes.
• Review and approve cleaning verification/validation protocols, reports, and associated risk assessments.
• Ensure validation activities comply with applicable FDA, ICH, USP, EU GMP, and regulatory requirements.
• Review and approve calibration, preventive maintenance, and qualification activities performed by internal departments and external service providers.
• Assess the quality and completeness of validation data packages and verify that acceptance criteria are scientifically justified and adequately supported.
• Participate in commissioning and qualification activities associated with new equipment, facilities, process improvements, and capital projects.
• Evaluate proposed changes through the Change Control system to determine qualification and validation impact.
• Review and approve deviations, investigations, CAPAs, and change controls associated with validation and qualification activities.
• Work cross-functionally with Manufacturing, Engineering/Facilities, Metrology, Validation,[DR2.1][TC2.2] Quality Control, and Technical Services to resolve validation-related compliance issues.
• Support internal audits, customer audits, and regulatory inspections related to validation programs.
• Assist in the development, revision, and continuous improvement of validation and quality system SOPs.
• Perform additional duties as assigned by Quality Management.
Leadership and Behaviour:
• Demonstrates integrity, accountability, and an independent quality mindset while consistently promoting cGMP compliance, data integrity, and patient-focused decision making.
• Collaborates effectively across departments to drive quality outcomes, resolve issues, and support timely execution of validation, qualification, and quality system activities.
• Exercises sound judgment, critical thinking, pragmatic and a risk-based approach when evaluating technical and compliance-related challenges.
• Leads by example through professionalism, continuous improvement, knowledge sharing, and a commitment to operational excellence and inspection readiness.
• Promote a culture of quality, data integrity, compliance, safety, and continuous improvement throughout the organization.
Qualifications:
Required
• Bachelor's degree in Chemistry, Biology, Engineering, Pharmaceutical Sciences, or a related scientific discipline.
• Minimum of 5 years of experience in Quality Assurance, Validation, Engineering, Quality Control, or Manufacturing within the pharmaceutical, biotechnology, or related regulated industry.
• Strong knowledge of cGMP regulations, including FDA 21 CFR Parts 210/211, applicable data integrity requirements, USP, and ICH guidance.
• Experience reviewing and approving qualification, validation, and lifecycle management documentation.
• Experience with process validation, equipment qualification, cleaning validation, and analytical method validation activities.
• Understanding of risk management principles and validation lifecycle concepts.
• Excellent technical writing, document review, and data evaluation skills.
• Strong organizational skills with the ability to manage multiple priorities.
• Effective verbal and written communication skills.
• Proficiency with Microsoft Office applications, including Word, Excel, PowerPoint, Outlook, and Teams.
Preferred
• 7+ years of GMP pharmaceutical or biotechnology industry experience.
• Experience with API manufacturing operations.
• Familiarity with computerized system validation (CSV) and data integrity assessments.
• Experience with chromatographic laboratory systems and Empower software.
• Previous participation in FDA, customer, or international regulatory inspections.
• ASQ Certified Quality Engineer (CQE), Certified Pharmaceutical GMP Professional (CPGP), or similar certification.
ADA Requirements
• Must be able to push, pull, squat, stand, and walk throughout the workday with or without reasonable accommodation.
• Must be able to lift up to 20 lbs.
• Must be able to wear required personal protective equipment, including safety glasses and safety shoes, while in designated areas.
• Must be medically qualified to wear a respirator when required for assigned duties.
• Must be able to work in a chemical manufacturing environment.