Junior Validation Engineer, CSV/CQV in Pharma
Overview
As a Junior Validation Engineer, you own validation and calibration for pharmaceutical and sterile-processing equipment at client sites in Waltham and Cambridge, Massachusetts. You support CSV and CQV activities, including IQ/OQ/PQ, under GMP and 21 CFR Part 11 standards. You join a team of validation, engineering, and quality experts, collaborating on critical equipment like CIP skids, isolators, and autoclaves. This role builds hands-on pharma validation experience, with potential for permanent hire after the initial contract.
What You'll Do8
- 1Perform validation and calibration for pharmaceutical and sterile-processing equipment, following GMP and 21 CFR Part 11.
- 2Support development and execution of Master Validation Plans, SOPs, and validation protocols.
- 3Assist with PPQ, aseptic processing, and cleaning and sterilization validation activities.
- 4Support equipment qualification, including IQ/OQ/PQ, and ongoing performance monitoring.
- 5Calibrate instruments such as dual-display light meters, open-air shakers, and scales.
- 6Validate CIP skids, isolators, parts washers, and autoclaves for cleaning or sterilization systems.
- 7Complete validation and qualification documentation accurately.
- 8Collaborate with validation, engineering, quality, and manufacturing teams.
Requirements8
- 1Entry-level candidates with up to 6 months of experience or academic knowledge in validation, calibration, CSV, CQV, or regulated environments.
- 2Basic understanding of GMP and 21 CFR Part 11 requirements.
- 3Familiarity with IQ/OQ/PQ and validation lifecycle documentation.
- 4Knowledge of Computerized System Validation is strongly preferred.
- 5Bachelor's degree in Engineering, Life Sciences, Pharmaceutical Sciences, Biotechnology, or related field is preferred.
- 6Strong attention to detail and documentation skills.
- 7Effective problem-solving, communication, and teamwork abilities.
- 8Must be available to work on-site in Waltham and Cambridge, Massachusetts.
Salary Insight
$62 - $67k per year
Similar open positions
Explore active roles that match your skills and interests.
1525 JuN - Seattle Dexter
VerifiedSenior Engineer I Validation
Lead validation efforts at a BMS facility to ensure GMP compliance and operational excellence. Drive validation projects and mentor team members to achieve high-quality outcomes. Shape the future of patient care through innovative solutions.
Katalyst Healthcares & Life Sciences
VerifiedSenior Validation Specialist, GMP & CSV
Lead validation lifecycle activities for equipment, facilities, utilities, processes, and computerized systems in a GMP-regulated environment at Katalyst Healthcares & Life Sciences in Raleigh, NC. You will own qualification and validation deliverables including DQ, IQ, OQ, and PQ, ensuring compliance with FDA, EMA, and cGMP regulations. Collaborate with Engineering, Quality, Manufacturing, Automation, and Regulatory teams to drive validation excellence. This contract role offers the chance to mentor junior engineers and influence validation strategy across multiple systems.
Compsciprep LLC
VerifiedCSV Validation Consultant, Life Sciences
You will own computer system validation for regulated life sciences environments, ensuring compliance with GxP and 21 CFR Part 11. You will work with cross-functional teams to validate ERP, LIMS, and MES systems. This role offers direct client exposure and the chance to shape validation strategies across multiple sites.
Emergent BioSolutions
VerifiedSr Engineer Validation, GMP & CSV
Own validation programs for cGMP manufacturing at Emergent BioSolutions, a public health leader. You will lead commissioning and qualification, computer systems validation, and laboratory systems validation across Canton, MA. Your work ensures compliance with CFR 210/211 and Part 11, supporting lifesaving products. You will collaborate with engineering, quality, and manufacturing teams, driving innovation and best practices. This role offers independence on multi-faceted projects and representation in regulatory inspections.
Interact Engineering LLC
VerifiedValidation Specialist - Aseptic Operations
Lead validation activities across sterile environments ensuring compliance with FDA EMA Annex 1 regulations. Drive performance impact on site success and customer satisfaction.
Performance Validation, Inc
VerifiedStaff Validation Engineer
Performance Validation, Inc seeks Staff Validation Engineers to join our FDA-regulated facilities across multiple locations. This hands-on role focuses on ensuring life-saving product systems operate correctly while investing heavily in employee growth.