Quality Assurance Engineer
2 weeks ago
Position: Validation Engineer - Equipment
Location: North Chicago, IL – Onsite
Contract Duration: 6+ months
Automated Systems, Inc. is seeking a skilled Validation Engineer to join our team, supporting a leading global Pharmaceutical Manufacturing client. In this role, the Validation Engineer will oversee the planning, execution, and assessment of validation initiatives to ensure compliance with facility, equipment, and process standards in accordance with cGMP regulations for sterile fill operations.
Key Responsibilities:
- Develop and implement IQ/OQ/PQ protocols and corresponding summary reports.
- Collaborate with both internal and external teams to define project objectives, priorities, and validation strategies.
- Manage validation projects associated with new or modified facilities, ensuring seamless integration across various functional areas.
- Conduct validation activities to support the manufacturing of oral solid dosage forms, including tablets, capsules, and powders.
Preferred Equipment Expertise:
- Bottle Fillers
- Blister Fillers
- Cappers
- Labelers
- Bar coding
- Uhlmann Thermoformers
- Cartoning
- Case packers
Job Duties:
- Lead the development, execution, and analysis of validation projects to ensure compliance with cGMP standards.
- Draft and execute protocols for packaging equipment and operations.
- Manage change controls, standard operating procedures (SOPs), and work instructions.
- Provide technical support for change controls, corrective actions, and deviations.
- Design and conduct process and cleaning validation studies in alignment with site and industry standards.
- Assist with product changeovers, troubleshooting investigations, and continuous improvement efforts.
- Work collaboratively with technical and management teams to optimize validation approaches and project outcomes.
Qualifications:
- Bachelor's degree in Pharmacy, Engineering, or a related field.
- Minimum of 2 years of experience in life sciences engineering.
- At least 1 year of experience in validation processes.
- Experience in an FDA/cGMP compliant environment is essential.
- Strong communication, collaboration, and presentation skills are required.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) is necessary.
Automated Systems, Inc. is a forward-thinking consulting firm that offers a diverse range of technical challenges. As we continue to grow rapidly, we are looking for talented professionals to join our team. We provide competitive compensation and comprehensive benefits. Automated Systems, Inc. is an equal opportunity employer.
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