What are the responsibilities and job description for the Validation Engineer position at JMD Technologies Inc.?
About the Job
Title: Validation Engineer
Location: Boston, MA (100% Onsite)
Employment Type: Contract
Status: Accepting Candidates
About the Role
We are seeking a Validation Engineer to support qualification, validation, and compliance activities within a regulated pharmaceutical or life sciences environment. This role will be responsible for developing and executing validation documentation, supporting equipment and analytical instrument qualifications, and ensuring compliance with GMP, GDP, and regulatory requirements.
Key Responsibilities
Validation & Qualification
- Author, review, and execute validation protocols including URS, IQ, OQ, and PQ documentation.
- Support qualification activities for analytical instruments, manufacturing equipment, and facility systems.
- Conduct analytical instrument qualifications in accordance with USP <1058> guidelines.
- Assist with process validation, equipment validation, and lifecycle management activities.
- Support sterilization cycle development, validation, and verification activities as required.
Compliance & Documentation
- Draft and maintain quality system documentation related to validation programs.
- Ensure validation activities are executed in compliance with GDP, GMP, and company procedures.
- Prepare validation reports, summaries, and supporting documentation.
- Maintain accurate records and ensure documentation readiness for audits and inspections.
Automation & Computer Systems
- Perform automation and computerized system assessments for compliance with 21 CFR Part 11 requirements.
- Support validation activities for automated systems and data integrity initiatives.
- Coordinate testing activities and document results to ensure regulatory compliance.
Cross-Functional Collaboration
- Work closely with Engineering, Manufacturing, Quality Assurance, Validation, and external vendors.
- Coordinate execution of test plans, qualification activities, and project deliverables.
- Support troubleshooting, investigations, and continuous improvement initiatives.
- Complete all required training and maintain compliance with company training requirements.
Qualifications
- Bachelor's degree in Engineering, Life Sciences, Chemistry, Biology, or a related technical field.
- Experience supporting validation and qualification activities in a regulated environment.
- Knowledge of validation lifecycle concepts and qualification protocols (URS, IQ, OQ, PQ).
- Familiarity with GMP, GDP, and regulatory compliance requirements.
- Strong technical writing, documentation, and organizational skills.
- Excellent communication and cross-functional collaboration abilities.
Compensation (MA Pay Transparency):
- Estimated hourly range: $55–$60/hr (W-2).
- Final rate within this range will be based on skills, experience, and interview results.
Salary : $55 - $60