Kindeva Drug Delivery · 5 hours ago
Senior Quality Systems Engineer II
Lexington, KY
Full-time
Onsite
Senior Level
5+ years expKindeva Drug Delivery is dedicated to making products that save lives and improve patient health globally. As a Senior Quality Systems Engineer II, you will ensure quality oversight and compliance in pharmaceutical development and manufacturing, focusing on equipment design and implementation while collaborating with various stakeholders.
Manufacturing
Responsibilities
Provide quality involvement and oversight during pharmaceutical development and manufacturing activities, particularly related to the design, qualification, and commissioning of new equipment and systems
Support and oversee facility and equipment changes, including activities related to FAT, SAT, URS, commissioning, decommissioning, and facility or laboratory moves
Provide quality oversight of new electronic system implementations, ensuring compliance with applicable regulatory and data integrity requirements
Observe critical operations and procedures, audit documentation and records, and communicate quality-related issues and risks to management
Support the development, maintenance, and execution of Quality Systems, including manufacturing investigations, change controls, CAPAs, and product complaint investigations
Review and approve cGMP documentation such as procedures, validation protocols, development reports, and related quality records
Participate in and support compliance assessments (e.g., GxP, Part 11) and regulatory inspections, as well as customer audits
Develop, maintain, and analyze compliance-related metrics and trending reports to support continuous improvement
Lead and support continuous improvement initiatives to strengthen compliance with DEA, FDA, and EMA regulations
Collaborate cross-functionally with internal teams and external suppliers to resolve quality issues and support the implementation of new technologies
Advise senior management on quality findings, risks, and recommendations
Support departmental projects and initiatives as assigned
Qualification
Required
Bachelor's degree in a scientific discipline or equivalent years of experience
At least 5+ years of cGMP experience, with at least 2 years in an engineering or quality assurance role
Ability to assess problems, to identify solutions, to plan and implement necessary changes
Knowledge of cGMP regulations and validation principles
Ability to work well in a team-oriented environment
Well-developed communication and technical writing skills
Qualified to work with controlled substances
Specific vision requirements include close vision, distance vision, color vision, and the ability to adjust and focus in order to read/understand/execute documentation as required by the position
Employees are required to follow all cGMP and safety procedures
The employee must wear all required safety equipment and perform assigned work safely
Employee must use proper lifting techniques and be conscious of hazards around him/her
Must follow all GMP and safety procedures within the department
The employee must occasionally lift and/or move up to 20 pounds
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
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