Sr. Validation Engineer

Aspire IT Solutions is in a need of -

Role: Senior Validation Engineer
Location: Norwood, MA (Onsite)
Duration: 6+ months contract

Job Description:

Our client is seeking a Senior Validation Engineer to support digital initiatives within the Bioanalytical and Molecular Assays (BMA) department of CASL. This role will report to the Senior Manager of Operations and focus on optimizing the Watson LIMS database and establishing data integrity solutions for metabolomic and genomic platforms.

Key Responsibilities:

• Partner with Operations to support the Data Integrity Risk Assessment (DIRA) initiative by identifying risks and closing gaps in validated data systems.
• Drive efficiency through integration of shipment manifests, EDC, and Watson LIMS for a seamless sample-to-data delivery workflow.
• Develop and execute validation documentation (Risk Assessments, User Test Cases) for analytical platforms including:
  • Orbitrap LC-MS (Metabolomics)
  • Illumina NextSeq2000 (Genomics/Exosome profiling)
• Represent BMA in implementing data storage and transfer solutions within AWS Cloud to ensure compliance and data integrity.

Required Qualifications:

• Master's degree in Engineering or related field, or equivalent experience.
• 5 8 years of experience in a regulated (GLPLP/GMP) pharmaceutical or biotech environment.
• Expertise in Computer Systems Validation (CSV) and instrument lifecycle management.
• Proven Subject Matter Expert (SME) in Watson LIMS.
• Strong knowledge of data integrity principles and digital compliance.
• Hands-on experience with Kneat, Veeva, and ServiceNow.
• Familiarity with Change Control, CAPA, and Continuous Improvement processes.

Preferred Qualifications:

• Excellent communication skills (verbal and written).
• Ability to work independently and collaboratively in cross-functional teams.
• Passion for contributing to a high-growth, innovation-driven environment.