What are the responsibilities and job description for the Validation Engineer position at the ASSURANCE group?
A high-growth life sciences services company supporting critical healthcare and manufacturing operations is seeking a Validation Engineer to work on-site (2pm – 10:30pm) and be responsible for ensuring facility, equipment, computer system, and process validations are executed in compliance with cGMP, ISO, and regulatory requirements. This role works cross-functionally with Production, Quality, Engineering, and Technical Services to maintain validated systems in a continuous state of compliance. The Validation Engineer develops risk assessments, validation protocols (DQ, IQ, OQ, PQ), executes validation studies, and authors final reports in accordance with company procedures and applicable regulatory standards.
The Validation Engineer Qualifications:
- Bachelor’s degree in Engineering or related scientific discipline required; Electrical Engineering background preferred.
- Working knowledge of cGMP, GAMP 5, GLP, ISO 9001, ISO 13485, ISO 17025, and 21 CFR Part 11 requirements.
- Understanding of sterilization science (steam, dry heat, VH₂O₂) preferred.
- Experience executing DQ, IQ, OQ, PQ, risk assessments, change control, and computer system validation (CSV).
- Lean manufacturing or Six Sigma experience preferred.
- Strong written and verbal communication skills.
- Proficiency with Microsoft Office (Word, Excel, Outlook, PowerPoint).
- Ability to work established shifts and tolerate occasional exposure to elevated
To discuss in greater detail, please send resume outlining your related experience.
Salary : $75,000 - $85,000