Validation Specialist II: CQV, Cold Chain & Shipping

SGS Consulting; Boston (MA); Sur place; USD 85 000 - 120 000; Plein temps

Résumé du poste

SGS Consulting in Boston seeks a CQV professional with 3–6 years of experience to support shipping validation, qualification activities, and cold chain processes in pharma manufacturing. You will document and validate IQ/OQ/PQ, assess risks, and ensure compliant protocol execution.

You will collaborate cross-functionally, handle logistics and regulatory considerations, and contribute to commissioning and qualification efforts in a highly regulated environment.

Qualifications

• BSc/BEng in a related field with 3–6 years CQV experience.
• Experience in pharmaceutical/biopharmaceutical industry or manufacturing environment.
• Shipping validation and cold chain experience.
• Strong documentation and communication skills.

Responsabilités

• Perform CQV activities in controlled environments, including cold rooms.
• Adhere to PPE requirements and safety protocols.
• Generate, execute and close validation protocols.

Connaissances

CQV documentation

IQ/OQ/PQ installation qualification

Qualification testing

Shipping validation

Logistics & customs

Risk assessment & protocol

Formation

BSc/BEng or equivalent

Description du poste

SGS Consulting in Boston seeks a CQV professional with 3–6 years of experience to support shipping validation, qualification activities, and cold chain processes in pharma manufacturing. You will document and validate IQ/OQ/PQ, assess risks, and ensure compliant protocol execution.

You will collaborate cross-functionally, handle logistics and regulatory considerations, and contribute to commissioning and qualification efforts in a highly regulated environment.