Validation Specialist II

SGS Consulting; Boston (MA); On-site; USD 85,000 - 120,000; Full time

Job summary

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.

Responsibilities

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

Skills

CQV documentation

IQ/OQ/PQ installation qualification

Qualification testing

Shipping validation

Logistics & customs

Risk assessment & protocol

Education

BSc/BEng or equivalent

Job description

Job Responsibilities

Lifting, temperature-controlled environments - cold room at times.PPE is required, glasses, vest, personal protective equipment (PPE), protocol generation, execution and closure

Skills

Familiar life cycle documentationIQ/OQ/PQ installation qualification, operational and performance qualificationDemonstrated expertise in shipping/transport validation processesExperience with logistics, customs, international shipments/ cold chain experienceRisk assessment, protocol generation, execution and closure.

Education/Experience

BSc/BEng plus previous experience in CQV field or equivalent combination of education and experience. Experience in pharmaceutical/biopharmaceutical industry or related industry/manufacturing environment. Areas of experience: Shipping Validation. Well-developed communication skills, both verbal and written..Years of Experience: 3 - 6 Years