Kindeva Drug Delivery · 1 day ago
Senior Quality Systems Engineer II
Lexington, KY, USA
Full-time
Onsite
Senior Level
5+ years expKindeva Drug Delivery is dedicated to creating products that save lives and enhance patient health globally. The Senior Quality Systems Engineer II will ensure quality oversight and compliance during pharmaceutical development and manufacturing, focusing on the design and implementation of new systems and equipment. This role involves collaborating with various teams to maintain regulatory readiness and support continuous improvement initiatives.
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
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