Validation EngineerAutomated Systems, Inc. • Chicago, IL, US
Validation Engineer
Automated Systems, Inc. • Chicago, IL, US
[job_card.variable_days_ago]
[job_preview.job_type]
- [job_card.full_time]
[job_card.job_description]Bachelor’s degree in engineering, Life Sciences, or related field. Minimum of 3 years’ experience in equipment qualification and validation activities, including IQ / OQ / PQ, and equipment validation in a regulated environment. Experience with pharmaceutical, biotech, or medical device manufacturing. Relevant experience of understanding the validation and pharma guidelines. Strong understanding of cGMP, FDA, and ISO requirements. Understanding of statistical analysis tools and methods. Direct experience with writing and executing validation protocols. Excellent technical writing and documentation skills. Proficient in data analysis and technical reports. Ability to work independently and cross-functionally within a fast-paced GMP manufacturing environment. Excellent communication and organizational skills. Strong analytical and problem-solving skills. Tech savvy person- hands on person, not afraid to learn or use computerized systems and equipment. Proficient in Word, Excel, and PowerPoint.
Job Description
Job Description
Validation Engineer
Location : Greater Chicagoland Area – Onsite
Contract Duration : 6+ months, with potential for extensions
Automated Systems, Inc. (ASI) is seeking an experience Validation Engineer to join the team at one of our pharmaceutical manufacturing clients located in the Greater Chicagoland Area. In this high-impact role, you’ll lead full-cycle validation efforts across equipment, processes, and facilities, playing a key part in ensuring compliance with cGMP and regulatory standards while supporting critical manufacturing operations.
Key Responsibilities :
- Support, plan, execute, and document equipment qualification and validation activities, including IQ / OQ / PQ.
- Develop and review protocols, reports, and deviations in accordance with cGMP and internal SOPs.
- Author and execute IQ / OQ / PQ Protocols packaging equipment and operations.
- Collaborate with cross-functional teams including Quality, Engineering, and Operations.
- Identify deviations and trends, recommend corrective actions, and ensure proper documentation.
- Author change controls, SOPs, and work instructions.
- Provide technical assistance to change controls / CAPA’s, and deviations.
- Ensure compliance with regulatory standards (FDA, ISO, etc.) and company policies.
Education & Experience Qualifications :
Skill Qualifications :
Company Description
We are a dynamic, project oriented consulting company offering individuals a wide variety of technical challenges. We are currently experiencing rapid growth, and are in need of talented individuals. ASI offers top wages and excellent benefits. ASI is an equal opportunity employer.
Company Description
We are a dynamic, project oriented consulting company offering individuals a wide variety of technical challenges. We are currently experiencing rapid growth, and are in need of talented individuals. ASI offers top wages and excellent benefits. ASI is an equal opportunity employer.
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