Junior Validation Engineer - CSV/CQV
Arthur Lawrence
Job Description
Job Description
We are seeking a Junior Validation Engineer to support validation, calibration, and qualification activities within pharmaceutical manufacturing and sterile-processing environments. This is an excellent opportunity for an entry-level professional or recent graduate looking to build a career in pharmaceutical validation, Computerized System Validation (CSV), and Commissioning, Qualification, and Validation (CQV).
Local candidates must be available to work on-site at client facilities in both Waltham and Cambridge, Massachusetts.
Key Responsibilities
- Perform validation and calibration activities for pharmaceutical manufacturing and sterile-processing equipment.
- Follow Good Manufacturing Practices (GMP) and 21 CFR Part 11 requirements.
- Support the development and execution of Master Validation Plans, Standard Operating Procedures, and validation protocols.
- Assist with process performance qualification (PPQ), aseptic processing, and cleaning and sterilization validation.
- Support equipment qualification activities, including Installation Qualification, Operational Qualification, and Performance Qualification (IQ/OQ/PQ).
- Assist with ongoing equipment performance monitoring.
- Calibrate instruments and equipment, including dual-display light meters, open-air shakers, and various types of scales.
- Support the validation of CIP skids, isolators, parts washers, autoclaves, and other cleaning or sterilization systems.
- Accurately complete validation and qualification documentation.
- Collaborate with validation, engineering, quality, and manufacturing teams.
Qualifications
- Entry-level candidates with up to six months of experience or academic knowledge related to validation, calibration, CSV, CQV, pharmaceutical manufacturing, or another regulated environment.
- Basic understanding of GMP and 21 CFR Part 11 requirements.
- Familiarity with IQ/OQ/PQ and validation lifecycle documentation.
- Knowledge of Computerized System Validation is strongly preferred.
- Bachelor’s degree in Engineering, Life Sciences, Pharmaceutical Sciences, Biotechnology, or a related discipline is preferred.
- Strong attention to detail and documentation skills.
- Effective problem-solving, communication, and teamwork abilities.
- Must be able to work on-site in both Waltham and Cambridge, Massachusetts.
Why Apply?
- Gain hands-on experience in pharmaceutical validation and CQV.
- Work with critical manufacturing and sterile-processing equipment.
- Build experience with GMP, CSV, IQ/OQ/PQ, calibration, and 21 CFR Part 11.
- Opportunity for permanent employment following the initial contract period.
Apply today if you are a recent graduate or junior validation professional ready to begin or advance your career in the pharmaceutical industry.
\nCompany DescriptionArthur Lawrence is a US-focused management consulting and staffing firm placing talent across IT, finance, light industries, and pharmaceuticals. We work with Fortune 500 clients and operate with a delivery-first mindset backed by a strong internal training culture.
Company Description
Arthur Lawrence is a US-focused management consulting and staffing firm placing talent across IT, finance, light industries, and pharmaceuticals. We work with Fortune 500 clients and operate with a delivery-first mindset backed by a strong internal training culture.
Vacancy posted 3 days ago
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