Role:Validation Engineer
Duration: 6+ Months
Location: Andover, MA
Pay Rate: $50-55/hr on W2
Job Description
We are seeking a Validation Engineer with strong experience in GMP/cGMP validation, quality documentation, compliance review, and root-cause analysis. The candidate will support validation and qualification activities across areas such as sterilization, packaging, cleaning, utilities, process, or computer validation.
Key Responsibilities
Perform technical and compliance review of GMP/cGMP documents and independently prepare technical documentation.
Manage specification, qualification, validation, requalification, and periodic review requirements.
Perform root-cause analysis using appropriate tools and techniques and support CAPA-related activities.
Analyze user requirements and convert them into design documents.
Conduct risk-based verification for GxP systems and laboratory equipment.
Support validation and characterization test automation through software and scripting, including product checkout and debugging.
Support engineering activities including PCB schematic/layout review and test fixture development.
Prepare and update DFMEA, Design History Files, CTQ changes, aging reports, inspection plans, and related validation documentation.
Write and execute engineering change orders related to CAPAs and other required changes.
Work effectively as a project team member and team leader with cross-functional teams.
Plan, organize, execute, review results, and revise work plans for complex problems.
Required Qualifications
5+ years of experience reviewing GMP documents for compliance and quality approval.
Expert knowledge of cGMP documentation practices and regulatory requirements.
Expertise in one or more core validation areas: sterilization, packaging, cleaning, utilities, process, or computer validation.
Knowledge of statistical methods and root-cause analysis techniques.
Experience with temperature mapping and Kaye validation equipment is desired.
Experience with Microsoft Word, Excel, and basic computer applications.
Strong technical writing, oral and written communication skills.
Demonstrated ability to make technical decisions and lead/participate in cross-functional project teams.
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