Kindeva Drug Delivery · 21 hours ago
Senior Manufacturing Engineer
Bridgeton, MO, USA
Full-time
Onsite
Senior Level
7+ years expKindeva Drug Delivery is a company dedicated to making products that save lives and improve patient health globally. They are seeking a Senior Aseptic Manufacturing Engineer to serve as a technical leader and subject matter expert for aseptic processing and sterile manufacturing technologies, ensuring compliance and high-performance manufacturing processes.
Manufacturing
Responsibilities
Act as the primary SME for aseptic manufacturing equipment, cleanroom environments, utilities (WFI, clean steam, compressed gases), and fill-finish systems (vial washers, depyrogenation tunnels, isolators/RABS, filling lines, cappers, lyophilizers, robotic systems, etc.)
Provide technical leadership for aseptic fill/finish operations, including process design, scale-up, validation, troubleshooting, and ongoing performance monitoring
Ensure robust aseptic practices and contamination control strategies (CCS) are implemented and sustained across all sterile operations
Lead or support equipment and process lifecycle activities, including design reviews, FAT/SAT, IQ/OQ/PQ, requalification, and decommissioning
Author, review, and approve technical documents such as SOPs, batch records, change controls, deviations, CAPAs, risk assessments, validation protocols/reports, and investigation reports
Perform root cause analysis (using tools such as Fishbone, 5-Why, FMEA) for process deviations, environmental monitoring excursions, and equipment failures; implement effective corrective and preventive actions
Drive process optimization and continuous improvement initiatives using Lean, Six Sigma, and data-driven approaches to increase yield, reduce cycle time, minimize interventions, and enhance sterility assurance
Provide engineering oversight and troubleshooting support during manufacturing campaigns, including real-time shop-floor support for complex technical issues
Collaborate with Quality Assurance, Validation, Microbiology, Regulatory, Supply Chain, Operations and MSAT teams to ensure successful tech transfers, new product introductions (NPI), and regulatory inspections
Support regulatory submissions and inspections by preparing technical packages and defending aseptic processes
Mentor and provide technical guidance to junior engineers, manufacturing technicians, and cross-functional team members
Monitor and analyze process performance metrics (e.g., yield, intervention rate, environmental monitoring trends, downtime) and implement improvements
Qualification
Required
Bachelor's degree (required) in Chemical Engineering, Mechanical Engineering, Biomedical Engineering, Pharmaceutical Engineering, or a related technical discipline
7+ years of hands-on engineering experience in cGMP pharmaceutical/biotech manufacturing, with at least 5+ years focused on aseptic fill/finish operations
Strong experience with isolator technology, RABS, vial/syringe/cartridge filling lines, lyophilization, aseptic connections, and closed-system processing
Proven track record supporting sterile product manufacturing (small molecules, biologics, gene/cell therapies, or vaccines)
Deep expertise in aseptic processing principles, sterilization methods, contamination control, and Annex 1 / FDA Guidance for sterile drug products
Familiarity with cleanroom design, environmental monitoring programs, media fills, and sterility assurance
Strong understanding of equipment qualification, process validation, and computer systems validation (CSV) in a GxP environment
Proficiency in technical problem-solving, statistical analysis (SPC, DOE, capability analysis), and risk management tools
Experience authoring and defending regulatory documents during audits/inspections
Excellent written and verbal communication skills; ability to present complex technical information clearly
Preferred
Master's degree or advanced technical certification preferred
Experience with robotic aseptic filling systems or advanced automation
Knowledge of single-use systems in aseptic processing
Previous experience in tech transfer, scale-up, or greenfield facility startup
Company
Kindeva Drug Delivery
Kindeva Drug Delivery is a global contract development and manufacturing organization (CDMO) in the pharmaceutical industry.
1001-5000 employees
H1B Sponsorship
Kindeva Drug Delivery has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (4)
2023 (1)
2022 (3)
Funding
Current Stage
Late StageTotal Funding
$46.96MKey Investors
Global Britain Investment Fund
2023-08-03Grant· $41.96M
2022-11-14Acquired
2022-06-13Series Unknown· $5M
Leadership Team
Brian Schubmehl
Chief Human Resources Officer
Recent News
2026-01-16
Bizjournals.com Feed (2025-11-12 15:43:17)
2026-01-16
MarketScreener
2026-01-01
Company data provided by crunchbase