American Regent, Inc., a Daiichi Sankyo Group Company, develops, manufactures, and supplies high quality sterile injectables for healthcare providers, clinics, hospitals and veterinary practices across the United States and Canada. We have locations in New York, Ohio, and Pennsylvania and sales territories nationwide.
Nature and Scope
The Process Automation Engineer – Packaging I is the SME of
Visual Inspection, Automatic Packaging, and serialization, working as part of
the Inspection/Packaging Team for the New Albany facility. The Process Automation Engineer – Packaging I
provides technical support and project leadership to all Visual Inspection
related subjects for New Albany site. This position will support both
commercial and Research & Development operations. The Engineer must possess
the ability to manage multiple tasks simultaneously, identify and implement
continuous improvement opportunities, and drive procurement and project closure
in an FDA regulated environment.
Essential Duties and Responsibilities
Nothing in this job description restricts
management’s right to assign or reassign duties and responsibilities to this
job at any time.
- Adjustment/tuning, Qualification, and Maintenance of
automated inspection and packaging equipment.
- Optimize detection of defects in final containers,
specifically for particulates.
- Technical trouble-shooting and deviation investigation
related to Visual Inspection and Packaging processes.
- Understand latest technical and regulatory trends in the pharmaceutical
imaging science, optical engineering and visual inspection arena.
- Understand and be able to identify inspection defect and
- Evaluate new products for Automatic Visual Inspection and Packaging
process, including but not limited to, component analysis and format.
- Support development, review, revision, and maintenance of
SOPs related to all Automatic Visual Inspection and Automated Packaging
- Develop, write and program new cycles for the automated
- Develop and maintain spare parts inventory specific to the
Automatic Visual Inspection equipment.
- Leads and supports all serialization initiatives.
- Assist and direct vendors and contractors as required on
equipment within area of responsibility.
- Assure compliance to GMP requirements, adherence to SOPs and
use of the change control system.
- Manage project costs to budget.
- Support new production and development equipment through
procurement, installation, commission and qualification activities.
- Identify, implement, and track process metrics for
- Perform any other tasks/duties as assigned by
Qualifications and Requirements
- BS Engineering discipline required.
- Minimum of 1 years of experience (PLC experience considered
an asset) preferred.
- Project Management experience preferred.
- Preferred experience in using computer systems in an
Physical Environment and Physical Requirements
- Physically able to wear cleanroom/protective gowning and
equipment, including but not limited to gowning, goggles, face shields, and
protective gloves. PPE is essential for the health and safety of
- Specific vision requirements include 20/20 near vision (can
be corrected with eyeglasses or contacts) and color vision.
We are an Equal Opportunity Employer and all qualified
applicants will receive consideration for employment without regard to race,
color, religion, sex, national origin, disability status, protected veteran
status, or any other characteristic protected by law.