Process Expert for Visual Inspection (Manufacturing Engineer)

Siegfried•Irvine, CA

3d•$110,000 - $125,000

About The Position

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 Strong knowledge of USP <790> and USP <1790> requirements Understanding of visual inspection principles, including: Human visual limitations, defect types (particulate, cosmetic, container closure defects), AQL and sampling strategies Experience with manual and automated inspection systems Knowledge of aseptic processing and fill-finish operations Strong understanding of GMP, data integrity, and regulatory compliance Excellent attention to detail and defect recognition capability Strong technical writing and documentation skills Ability to analyze data and perform statistical trending Strong communication, collaboration, and leadership skills Ability to multi-task and manage multiple projects simultaneously Proficiency in MS Word, Excel, and PowerPoint Physical ability to perform prolonged visual inspection tasks and lift/push/pull up to 50 pounds 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. Application Submission & Screening: Share your qualifications and enthusiasm through our application process. We review each submission to identify candidates whose skills best match the role. Initial Interview: We’ll explore your background, aspirations, and how you could contribute to our mission and culture. On-Site Interview: If possible, we invite you to meet us in person, connect with future colleagues, and get a feel for our workspace. Offer Stage: Congrats! If selected, you'll receive a detailed offer including compensation, benefits, and the exciting opportunities ahead. Onboarding: After you accept, we’ll guide you through a smooth, tailored onboarding experience to help you settle into your new role. Feedback & Improvement: Your feedback helps us continuously improve and enhance the candidate experience for others. Create an account by clicking ‘Sign In’ at the top of the page to set up personalized email alerts when new roles that match your aspirations become available.

Requirements

Strong knowledge of USP <790> and USP <1790> requirements
Understanding of visual inspection principles, including: Human visual limitations, defect types (particulate, cosmetic, container closure defects), AQL and sampling strategies
Experience with manual and automated inspection systems
Knowledge of aseptic processing and fill-finish operations
Strong understanding of GMP, data integrity, and regulatory compliance
Excellent attention to detail and defect recognition capability
Strong technical writing and documentation skills
Ability to analyze data and perform statistical trending
Strong communication, collaboration, and leadership skills
Ability to multi-task and manage multiple projects simultaneously
Proficiency in MS Word, Excel, and PowerPoint
Physical ability to perform prolonged visual inspection tasks and lift/push/pull up to 50 pounds
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
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

Nice To Haves

Experience with aseptic manufacturing processes strongly preferred
Experience qualifying inspection equipment and systems

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