Job ID: JOB_ID_7182
Job Summary:
We are seeking an experienced and detail-oriented Validation Engineer with 5-8 years of experience to support validation activities across multiple U.S. locations. The ideal candidate will have strong expertise in validation processes within regulated industries such as pharmaceuticals, biotechnology, or medical devices, ensuring compliance with industry standards and regulatory requirements.
Key Responsibilities:
- Develop, execute, and review validation protocols including IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification)
- Perform validation for equipment, utilities, cleaning processes, and computerized systems
- Prepare and review validation documentation such as Validation Plans, Risk Assessments, URS, FS, DS, and Traceability Matrices
- Ensure compliance with FDA regulations, cGMP guidelines, and 21 CFR Part 11
- Collaborate with cross-functional teams including Quality, Engineering, Manufacturing, and IT
- Support audits and inspections by regulatory authorities and internal QA teams
- Conduct deviation investigations, CAPA implementation, and change control activities
- Participate in commissioning and qualification activities for new equipment and systems
- Ensure all validation activities are completed within timelines and in accordance with company SOPs
Required Qualifications:
- Bachelors degree in Engineering, Life Sciences, or a related field
- 5-8 years of experience in validation within pharmaceutical, biotech, or medical device industries
- Strong knowledge of cGMP, FDA guidelines, and validation lifecycle
- Hands-on experience with equipment qualification, process validation, and CSV (Computer System Validation)
- Experience with documentation and compliance tools
- Excellent analytical, problem-solving, and communication skills
Preferred Qualifications:
- Experience with cleanroom validation, sterilization validation, or packaging validation
- Familiarity with data integrity and risk-based validation approaches
- Experience working across multiple sites or in a consulting environment
- Knowledge of automation systems (SCADA, PLC) is a plus
Key Skills:
- Validation Lifecycle Management
- Regulatory Compliance (FDA, cGMP)
- Documentation & Technical Writing
- Risk Assessment & Mitigation
- Cross-functional Collaboration
Special Requirements
Locations: Boston, MA; New Jersey; Maryland; New York; Virginia. Experience in regulated industries (pharmaceuticals, biotechnology, medical devices) required. Knowledge of cGMP, FDA regulations, 21 CFR Part 11.
Compensation & Location
Salary: $50 – $70 per year (Estimated)
Location: Boston, MA
Recruiter / Company – Contact Information
Email: r@dsysinc.com
Recruiter Notice:
To remove this job posting, please send an email from
r@dsysinc.com with the subject:
DELETE_JOB_ID_7182