QA Validation Engineer
Listed on 2026-09-24
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Quality Assurance - QA/QC
Quality Engineering
Ambio Pharm is a full-service peptide development and manufacturing company headquartered in North Augusta, South Carolina. In addition to our USA headquarters, we have manufacturing facilities in the U.S. and Shanghai, China. We have a global sales team working together from around the world.
We are always looking for high-quality, industry-leading individuals to join our team.
We often have Open Positions in the following departments:- Peptide Manufacturing
- Process Development
- Project Management
- Quality Control
- Quality Assurance
- Human Resources
- Finance
Position: QA Validation Engineer
Location: North Augusta, SC
Remote Status: On-Site
Job :256
# of Openings:1
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.
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,…
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