INCOG BioPharma Services · 1 day ago
Principal MSAT Engineer (AVI & Device)
Fishers, IN
Full-time
Onsite
Lead/Staff
10+ years expINCOG BioPharma Services is a fast-growing CDMO focused on parenteral injectable drugs. The Principal MSAT Engineer for Automated Vision Inspection & Device is responsible for overseeing the visual inspection program, ensuring quality standards, providing expert guidance, and collaborating with cross-functional teams to enhance processes and compliance.
BiopharmaBiotechnologyManufacturingPharmaceutical
Responsibilities
Lead the design, development, and implementation of risk-based strategies for visual inspection of different products (e.g., syringes, cartridges, vials)
Serve as go-to expert on visual inspection processes, equipment and quality standards
Conduct root cause analysis and implement corrective and preventive actions (CAPA) for quality-related events
Collaborate with cross-functional teams involving process engineering, operations, quality assurance to identify and implement process improvements
Ensure compliance with FDA and global regulatory bodies by keeping inspection processes and documentation up to date
Act as a subject matter expert for the development and maintenance of internal strategy documents and execution documents to support visual inspection programs
Participate in internal and external audits, providing expert insights and support
Explore and evaluate new technologies and methodologies in visual inspection
Qualification
Required
Bachelor's degree in Chemistry, Engineering, or a related field
10+ years of experience working in a GMP-regulated environment
5+ years of experience in visual inspection for biopharmaceutical products
In-depth knowledge of visual inspection standards, practices, and equipment
Familiarity with regulatory guidance (FDA, EMA) and experience in regulatory inspections
Preferred
Advanced degree preferred
Proven record of developing training programs and mentoring inspection team
Experience with automated visual inspection systems
Company
INCOG BioPharma Services
Our services include injectable drug product formulation development, analytical method development, process scale up, and formulation & filling of vials, syringes and cartridges.
201-500 employees
Funding
Current Stage
Growth StageTotal Funding
$86.63M2024-05-29Series B· $42.86M
2022-05-10Undisclosed· $15M
2022-05-10Debt Financing
Leadership Team
Tedd Green
Co-founder & Chief Operating Officer
Recent News
Inside INdiana Business
2025-12-16
Company data provided by crunchbase