Kindeva Drug Delivery · 1 day ago
Senior Quality Engineer
Lexington, KY
Full-time
Onsite
Senior Level
5+ years expKindeva Drug Delivery is a company dedicated to making products that save lives and improve patient health globally. As a Senior Quality Engineer, you will ensure quality oversight and compliance in pharmaceutical development and manufacturing, focusing on new equipment and systems implementation.
Manufacturing
Responsibilities
Support the induction and management of changes of facilities and equipment, including but not limited to: FAT, SAT, URS, etc., for new equipment, facility expansion and commissioning, facility decommissioning, and laboratory or facility movement
Oversight of New E-system Implementation
Supports the development and maintenance of Quality Systems as appropriate, including leading and supporting manufacturing investigations, change controls, CAPAs, product complaint investigations, and related activities
Leads continuous improvement objectives to ensure compliance with DEA, FDA, and EMA regulations
Advises senior management on findings and recommendations related to quality issues
Reviews and approves cGMP documentation, including procedures, validation protocols, development reports, and other related documents
Develops and maintains metrics and trending reports for Compliance-related activities
Performs activities associated with various one-time or ongoing projects
Collaborates with departments and external suppliers regarding quality concerns
Participates and/or coordinates Compliance Assessments of departments as necessary (GXP, Part 11, etc.)
Supports regulatory inspections and customer audits
Assist the Manager with daily and project activities as needed
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
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2026-01-16
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2026-01-01
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