Job Title:Quality Assurance Validation (QAV) Engineer
Company: Intellectt Inc.
Location: Boston, MA
Work Environment: Onsite
payrate: $40/hour
Job Description:
Intellectt Inc. is seeking a QAV Engineer to support GMP equipment qualification, commissioning, validation, and quality compliance in pharmaceutical manufacturing. Hands-on oral solid dosage (OSD) manufacturing experience is mandatory.
Key Responsibilities
- Prepare and execute validation protocols, plans, and reports.
- Support commissioning and qualification of pharmaceutical equipment, facilities, and utilities.
- Perform equipment qualification, functional testing, and performance qualification.
- Review URS, risk assessments, traceability matrices, and Part 11 assessments.
- Manage CAPAs, deviations, change controls, and compliance gaps.
- Maintain GMP documentation and support validation lifecycle activities.
Required Skills
- Quality Assurance Validation (QAV)
- Equipment Qualification
- Commissioning & Qualification (C&Q)
- Oral Solid Dosage (OSD) Manufacturing
- GMP / cGMP Compliance
- Validation Protocols & Reports
- CAPA & Change Control
- Risk Assessments
Preferred Skills
- Cleaning and Process Validation
- Sterilization
- Computerized System Validation (CSV)
- Pharmaceutical Quality Assurance
- Cell and Gene Therapy
Recruiter Contact
Soundarya Kondra
Email:
soundarya.kondra@intellectt.com
Phone: 732-204-6899Benefits
Employees hired into this position are eligible for benefits subject to 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 the full cost of insurance premiums.
- Retirement: A 401(k) retirement savings plan is available. No employer matching or other employer contributions are provided.
- Paid Time Off: No PTO is provided beyond what is required by applicable state and local laws.
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.