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

Note :

• Need Local to MA with same State Id 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 Candels 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:

• Bachelors 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.