QA Validation Engineer

This role is onsite at our North Augusta, South Carolina location. Relocation is required,

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.

• 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, 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.

• 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.

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…