Contract jobs
Location: Boston, Massachusetts; New Jersey; Maryland; New York; Virginia
Duration: 6+ Months
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:
Bachelor’s 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
To apply for this job email your details to noor@dsysinc.com