Quality Assurance Validation Qav Engineer

Job Title: Quality Assurance Validation (QAV) Engineer

Company: Intellectt Inc

Location: Boston, MA Area

Experience: 3+ years

Payrate: $40-$45/hr on W2

Job Summary:

Seeking a QAV Engineer to support GMP equipment qualification, validation, and quality compliance within pharmaceutical manufacturing. Oral solid dosage manufacturing experience is mandatory.

Key Responsibilities:

• Author, revise, execute, review, and approve validation plans, SOPs, protocols, and reports.
• Support commissioning and qualification of facilities, utilities, production, laboratory, and support equipment.
• Perform installation verification, functional testing, and performance qualification, including cold storage, autoclaves, and warehouse operations.
• Review lifecycle documents, including URS, risk assessments, traceability matrices, and Part 11 assessments.
• Identify compliance gaps, own CAPAs, investigate equipment-related quality events, and assess change controls for validation impact.
• Prepare decommissioning reports and maintain compliant GMP documentation.

Required Qualifications:

• Bachelor's degree or equivalent in Engineering, Science, or a related discipline.
• 3+ years of experience in GMP pharmaceutical or biopharmaceutical manufacturing.
• Hands-on oral solid dosage experience.
• Direct commissioning, qualification, and validation experience with GMP facilities, utilities, and equipment.
• Strong knowledge of risk-based validation, cGMP, FDA, ICH, EMA, and ISPE/PDA guidelines.
• Strong technical writing, communication, and cross-functional collaboration skills.

Preferred: Pharmaceutical QA experience; cleaning, sterilization, process validation, or computerized system validation experience. Cell and gene therapy exposure is a plus.

Equal Employment Opportunity:

Intellectt Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, disability, genetic information, veteran status, or any other characteristic protected by applicable federal, state, or local law.

Benefits: Employees hired into this position are eligible for the following benefits, subject to the applicable plan terms and eligibility requirements:

Health Insurance: Medical, dental, and vision insurance options are available through a third-party provider. Employees are responsible for paying the full cost of their insurance premiums.

Retirement Benefits: A 401(k)retirement savings plan is available. No employer matching or other employer contributions are provided.

Paid Time Off (PTO): No PTO other than that required by applicable state and local laws.

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