Job title : Process Engineer (Commissioning and Qualification Validation)
Location : Rensselaer, NY
Duration : 1 year
Job description / summary : We are seeking an experienced Senior Process Engineer who has AVI Qualification experience to join our clients team.
This role will play a pivotal part in transitioning and qualifying new automated visual inspection (AVI) equipment to support the clients’ high standards in quality assurance.
You will be responsible for ensuring that our AVI systems are correctly installed, qualified, and operational, aligning with regulatory requirements and industry best practices.
Job Responsibilities :
- Lead the commissioning and qualification of new AVI machines that transition between syringe and vial inspections, ensuring seamless integration into production.
- Execute and document Installation Qualification (IQ) protocols for AVI equipment, ensuring it meets established standards.
- Develop, review, and execute validation protocols, coordinating with cross-functional teams to ensure successful qualification.
- Understand and apply manual inspection processes as they relate to automated visual inspection, ensuring accurate quality outcomes.
- Collaborate with the quality and engineering teams to troubleshoot and resolve technical issues related to AVI systems.
- Provide training and guidance to team members on AVI equipment operations, ensuring consistent understanding of inspection protocols.’
Req Skills :
- Bachelor’s degree in Engineering, Life Sciences, or a related field.
- Demonstrated experience with automated visual inspection systems in a pharmaceutical or biotech environment.
- Strong expertise in Installation Qualification (IQ) and process validation for automated inspection equipment.
- Hands-on experience with both manual and automated visual inspection processes.
- Excellent communication and technical documentation skills, with a focus on protocol development and adherence.
Preferred Skills :
- Familiarity with filling lines and various inspection formats, including semi-automated and fully automated systems.
- Proven problem-solving abilities with a strong focus on execution and achieving measurable results.
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