Urgent On-Site Opening for Senior CSV Engineer - Needham, MA - Need Local to MA Only.

Job Description

Job Description

Note :

• Need Local to MA, with same State I’d Only.

Position Overview :

• Need someone with Lab experience.
• We are looking for 4 Senior Computer System Validation (CSV) Engineer to perform validation of computerized systems associated with Candel’s QC Laboratory reactivation project.
• This role will focus on EMS, BMS, and laboratory informatics/software platforms (e.g., HPLC/qPCR control software, SciNotes, Blue Mountain), ensuring compliance with 21 CFR Part 11, Annex 11, and data integrity requirements.
• The CSV Engineer will develop and execute validation deliverables, manage ERES assessments, and provide GMP-ready reports within the accelerated project schedule.

Tasks, Responsibilities, and Deliverables:

• Draft and execute URS for computerized lab systems and informatics platforms.
• Perform and document risk assessments and ERES (Electronic Records and Electronic Signatures) assessments.
• Develop and execute validation deliverables: FS/DS, IQ, OQ, PQ protocols, and traceability matrices.
• Validate EMS/BMS systems for environmental monitoring and building controls.
• Validate laboratory software platforms, including HPLC/qPCR data systems, SciNotes, and Blue Mountain.
• Verify compliance with data integrity principles (ALCOA+), Part 11, and Annex 11 requirements.
• Document results, deviations, and resolution activities.
• Deliver complete GMP-ready CSV reports for QA review and approval.
• Collaborate with CQV Engineers, Technical Writers, and QA to ensure consistency across FEU, LEQ, and CSV validation workstreams.

Required Skills, Scope, and Experience:

• Bachelor’s degree in Computer Science, Engineering, or related technical field.
• 8–10 years’ experience in computer system validation within GMP-regulated pharmaceutical/biotech environments.
• Strong knowledge of 21 CFR Part 11, EU Annex 11, data integrity, and GAMP 5.
• Proven experience validating EMS, BMS, and laboratory informatics/data systems.
• Proficiency in authoring and executing FS/DS, IQ, OQ, PQ, and trace matrices.
• Experience performing ERES assessments and applying risk-based validation approaches.
• Familiarity with eQMS or informatics platforms (e.g., SciNotes, Blue Mountain, Empower, LabWare).
• Strong technical writing and documentation skills.
• Ability to manage parallel CSV activities in a compressed timeframe with accuracy and compliance.