GMP QAV Engineer - CQV & Validation Expert

United Pharma Technologies Inc; Massachusetts; Vor Ort; USD 51.000 - 73.000; Vollzeit

Benefits dieser Stelle

Health Insurance

401(k) retirement plan

Zusammenfassung

United Pharma Technologies Inc is seeking an experienced QAV Engineer to support a pharmaceutical client in Boston, MA. The role focuses on quality assurance, equipment qualification, and validation within a GMP manufacturing environment, with a strong emphasis on CQV activities and cGxP compliance.

The engineer will lead CAPAs, execute IQ/OQ/PQ, review validation plans and reports, and collaborate with engineering and cross-functional teams to maintain GMP standards.

Qualifikationen

• Bachelor's degree in Engineering or Science required.
• 3+ years in GMP manufacturing facilities.
• Mandatory OSD experience.
• CQV experience for facilities, utilities, or equipment.
• Strong knowledge of validation lifecycle and cGxP.
• Experience with FDA, cGMP, ICH, ISO, EMA, ISPE, PDA guidelines.
• Excellent documentation and cross-functional collaboration.

Aufgaben

• Perform quality engineering activities and remediate GMP gaps.
• Lead and own CAPAs for quality and compliance issues.
• Execute installation verification, IQ/OQ/PQ and equipment qualification.
• Support validation for cold storage, autoclaves, and warehouse ops.
• Develop and review validation plans, SOPs, and reports.
• Review lifecycle docs: URS, risk assessments, traceability matrices.
• Investigate quality events related to qualified equipment.
• Assess change controls for validation impact and decommissioning.

Kenntnisse

QA/QC

GMP Compliance

Documentation

Cross-functional Collaboration

Ausbildung

Bachelor's degree in Engineering or Science

Tools

CQV

Regulatory Guidelines (FDA/cGXP)

Jobbeschreibung

United Pharma Technologies Inc is seeking an experienced QAV Engineer to support a pharmaceutical client in Boston, MA. The role focuses on quality assurance, equipment qualification, and validation within a GMP manufacturing environment, with a strong emphasis on CQV activities and cGxP compliance.

The engineer will lead CAPAs, execute IQ/OQ/PQ, review validation plans and reports, and collaborate with engineering and cross-functional teams to maintain GMP standards.