Validation Engineer
Job in
Erie, Erie County, Pennsylvania, 16501, USA
Listed on 2026-07-03
Listing for:
GxP Associates
Full Time
position Listed on 2026-07-03
Job specializations:
-
Engineering
Quality Engineering, Pharma Engineer, Biomedical Engineer -
Quality Assurance - QA/QC
Quality Engineering
Job Description & How to Apply Below
We are seeking a motivated Validation Engineer to join our team in Pennsylvania. This role is ideal for candidates with 0–3 years of experience who are looking to build their careers in the pharmaceutical, biotechnology, medical device, or life sciences industry. The successful candidate will support equipment qualification, validation, commissioning, and documentation activities while ensuring compliance with GMP and regulatory requirements.
Key Responsibilities- Execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for manufacturing equipment, utilities, and systems.
- Support commissioning and qualification (CQV) activities throughout the project lifecycle.
- Prepare, review, and execute validation protocols, reports, and related documentation.
- Perform equipment walkdowns and field verification to ensure systems are installed and operating as designed.
- Assist with process validation, cleaning validation, and equipment qualification activities.
- Identify, document, and support the resolution of deviations and non-conformances.
- Ensure all validation activities comply with GMP, GDP, FDA, and company quality standards.
- Collaborate with Engineering, Manufacturing, Quality Assurance, and Operations teams to complete validation projects on schedule.
- Bachelor's degree in Mechanical Engineering, Chemical Engineering, Biomedical Engineering, Life Sciences, or a related technical discipline.
- 0–3 years of experience in validation, commissioning, quality, manufacturing, or engineering within a regulated industry.
- Basic understanding of validation lifecycle, GMP, GDP, and FDA regulations.
- Strong technical writing, analytical, and problem-solving skills.
- Excellent communication and teamwork abilities.
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