What are the responsibilities and job description for the CQV Validation Engineer (Equipment & Computer Systems) position at JMD Technologies Inc.?
Title: CQV Validation Engineer (Equipment & Computer Systems)
Location: Greater Boston Area, MA (Onsite 5 days per week)
Employment Type: Contract
Status: Accepting Candidates
About the Role
We are seeking a CQV Validation Engineer to support commissioning, qualification, and validation activities within a GMP-regulated manufacturing environment. This role will work cross-functionally to execute equipment and computer system validation activities while ensuring compliance with quality and regulatory requirements.
Key Responsibilities
- Author and execute URS, IQ, OQ, and PQ protocols in compliance with GDP and internal quality standards.
- Perform equipment qualification, including analytical instruments and manufacturing systems.
- Support Computer System Validation (CSV) and conduct automation assessments for 21 CFR Part 11 compliance.
- Coordinate and execute CQV activities with internal stakeholders and external vendors.
- Support validation documentation related to process validation, material qualifications, and manufacturing operations.
- Ensure all validation activities align with GMP, GAMP, ISO, and internal quality requirements.
Qualifications
- Bachelor's degree in Engineering or a related discipline.
- 5–8 years of experience in Validation Engineering within a GMP-regulated environment.
- Hands-on experience with Equipment Validation, IQ/OQ/PQ execution, and CSV activities.
- Knowledge of 21 CFR Part 11, GMP, GAMP, and validation lifecycle principles.
- Experience qualifying analytical instruments and automated manufacturing equipment.
- Ability to manage multiple projects and adapt to changing priorities in a fast-paced environment.
Compensation (MA Pay Transparency):
- Estimated hourly range: $50–$60/hr (W-2).
- Final rate within this range will be based on skills, experience, and interview results.
Salary : $50 - $60