"Expect to grow", personally and professionally: At Siegfried, we offer exciting challenges and ample opportunities to showcase your talents. As a trusted and respected partner to the pharmaceutical industry, we uphold the highest standards in safety, quality and sustainability, while fostering a culture that empowers you to thrive. Join a rapidly expanding global company, where diverse perspectives and experiences come together in a collaborative environment. Here, you'll find a workplace that values both collective success and your individual contributions-offering long-term opportunities to grow and make an impact.
Your Role:
The Process Expert for Visual Inspection is responsible for the development, implementation, qualification, and continuous improvement of visual inspection processes for parenteral drug products in compliance with USP <790> (Visible Particulates in Injections) and USP <1790> (Visual Inspection of Injections).
This role ensures that manual and/or automated inspection processes consistently detect particulate matter and cosmetic defects, while maintaining compliance with GMP, regulatory, safety, and environmental requirements.
The Process Expert will lead inspection lifecycle activities including: method development, qualification, training, and continuous monitoring, while demonstrating a strong commitment to product quality, patient safety, and operational excellence.
Your Profile:
Responsibilities
Own and maintain visual inspection program documentation
Ensure compliance with USP <790> and USP <1790> requirements
Develop, qualify, and optimize visual inspection processes
Lead and execute inspection qualifications, including:
Inspector training and certification programs
Periodic requalification and performance monitoring
Equipment IQ/OQ/PQ for inspection systems
Perform and support investigations
Collect, analyze, and trend inspection data
Support process validation activities
Lead continuous improvement initiatives
Own inspection equipment lifecycle, including:
Preventive maintenance, calibration, and requalification
Spare parts management and vendor coordination
Troubleshooting and minor repairs
Provide training and technical guidance to production and quality teams on visual inspection techniques, defect identification and classification, GMP and data integrity practices
Collaborate cross-functionally with Quality, Manufacturing, and Engineering
Ensure compliance with GMP, FDA, and global regulatory expectations
Support production operations as needed, including off-shift or extended hours
Required Knowledge, Skills, and Abilities
Required Education and Experience
Bachelor's degree in Biological Sciences, Engineering, or related discipline
Minimum 3 years of experience in GMP pharmaceutical manufacturing, QA/QC, or visual inspection
Hands-on experience with: Visual inspection qualification programs, defect classification and inspection standards, Inspection process validation and lifecycle management
Experience with aseptic manufacturing processes strongly preferred
Experience qualifying inspection equipment and systems
Proficiency in technical writing and GMP documentation
Ability to follow detailed SOPs and manage extensive documentation with QA review cycles
Willingness to:
Work up to 50% on the production floor
Support off-shift schedules (e.g., 3:00 PM - 12:00 AM), weekends, and overtime
Knowledge of PPE requirements for aseptic and controlled environments:
Gowning (scrubs, Tyvek suits, lab coats) Gloves, masks, goggles, and appropriate footwear
Target Pay Range: $110,000 - 125,000
Individual compensation packages are based on various factors unique to each candidate, including skill set, experience, qualifications and other job-related reasons.
Your Benefits:
Medical, Dental, Vision
Flexible Spending & HSA Options
Life Insurance, Short & Long Term Disability
Pet Insurance
401K
Founded in 1873 in Zofingen, Switzerland, Siegfried has grown into a global network of 13 sites across three continents. With a team of more than 3,800 highly skilled professionals, we take the innovations of our pharmaceutical customers to industrial scale and manufacture safe drugs for patients worldwide. As a fully integrated CDMO, Siegfried is one of the few organizations today that can carry out the development and manufacturing of APIs and finished dosage forms under one roof. This unique combination of know-how and experience makes us the most trusted partner in the pharmaceutical industry.