Senior QA Validation Engineer — GMP Compliance Expert

United Pharma; South Carolina; Presencial; USD 90.000 - 130.000; Jornada completa

Descripción de la vacante

United Pharma is seeking a Quality Assurance Validation Engineer to provide independent QA oversight of qualification and validation activities for manufacturing processes and related systems. The role ensures compliance with cGMP, regulatory requirements, and company standards while partnering with Manufacturing, Engineering, Quality Control, and Technical Services to maintain inspection readiness.

The successful candidate will review and approve VMPs, IQ/OQ/PQ, cleaning validation, and

Formación

• Bachelor's degree in Chemistry, Biology, Engineering, Pharmaceutical Sciences, or related field.
• Minimum of 5 years of experience in Quality Assurance, Validation, Engineering, Quality Control, or Manufacturing within the pharmaceutical/biotech industry.
• Strong knowledge of cGMP regulations, including FDA 21 CFR Parts 210/211, USP, and ICH guidance.
• Experience reviewing qualification, validation, and lifecycle management documentation.
• Experience with process validation, equipment qualification, cleaning validation, and analytical method validation.
• 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; proficiency with Microsoft Office.

Responsabilidades

• Perform QA review and approval of validation lifecycle documentation (VMPs, risk assessments, protocols, reports, periodic reviews).
• Review and approve equipment qualification documentation (URS, DQ, IQ, OQ, PQ).
• Review and approve utility qualification activities for GMP manufacturing and laboratory systems.
• Review and approve process validation protocols and reports for commercial API manufacturing processes.
• Review and approve cleaning verification/validation protocols and related risk assessments.
• Ensure validation activities comply with FDA, ICH, USP, and EU GMP requirements.
• Review and approve calibration, preventive maintenance, and qualification activities.
• Assess validation data packages for scientific justification and adequacy of acceptance criteria.
• Participate in commissioning and qualification of new equipment, facilities, and capital projects.
• Evaluate proposed changes via Change Control for qualification/validation impact.
• Review and approve deviations, investigations, CAPAs, and changes related to validation and qualification.
• Collaborate cross-functionally to resolve validation-related compliance issues.
• Support internal and customer audits and regulatory inspections related to validation programs.
• Assist in developing, revising, and improving validation and quality system SOPs.
• Perform additional duties as assigned by Quality Management.

Conocimientos

QA

Validation

cGMP knowledge

Documentation

Collaboration

Educación

Bachelor's degree

Descripción del empleo

United Pharma is seeking a Quality Assurance Validation Engineer to provide independent QA oversight of qualification and validation activities for manufacturing processes and related systems. The role ensures compliance with cGMP, regulatory requirements, and company standards while partnering with Manufacturing, Engineering, Quality Control, and Technical Services to maintain inspection readiness.

The successful candidate will review and approve VMPs, IQ/OQ/PQ, cleaning validation, and