Kindeva Drug Delivery · 20 hours ago
Manager, Validation Engineer
Lexington, KY, USA
Full-time
Onsite
Senior Level, Lead/Staff
10+ years expKindeva Drug Delivery is a company dedicated to creating products that save lives and enhance patient health globally. The Validation Engineer Manager will lead validation strategies across various manufacturing processes and ensure compliance with regulatory standards while developing a high-performing team in a fast-paced environment.
Manufacturing
Responsibilities
Provide leadership, direction, and technical guidance to Validation Engineers to ensure consistent application of risk-based validation principles across all validation activities
Establish validation priorities, allocate resources, and set execution direction to meet site, project, and customer timelines
Drive continuous improvement initiatives related to validation lifecycle execution, documentation efficiency, and risk management practices
Support and lead improvement programs, including Six Sigma initiatives
Ensure validation activities comply with applicable regulatory requirements and industry standards, including FDA (Food and Drug Administration), EMA (European Medicines Agency), ICH (International Council for Harmonisation), and global GMP (Good Manufacturing Practice) expectations
Review and approve validation protocols, investigations, and technical documentation to ensure accuracy, compliance, and audit readiness
Provide expert interpretation of regulatory guidance and defend validation strategies during internal and external audits
Participate in inspection readiness activities and regulatory inspections
Act as a technical interface with external customers, providing clear communication and expert guidance on validation strategy, execution, and risk justification
Collaborate with Quality Engineers, Manufacturing Engineers, Process Engineers, Regulatory, and Project Teams to align validation activities with company priorities
Participate in NPI (New Product Introduction) activities as they relate to validation planning and execution
Ensure Validation Engineers have clear job expectations, routine accountabilities, and defined SMART (Specific, Measurable, Achievable, Relevant, Time-bound) objectives
Conduct regular 1:1 meetings, performance reviews, and development planning for direct reports
Maintain personal and team training records, ensuring compliance with EPR (Employee Performance Review) and MTR (Manufacturing Training Record) processes
Mentor and develop validation staff to build technical depth, regulatory confidence, and leadership capability
Review and approve SOPs (Standard Operating Procedures), validation protocols, technical reports, deviations, CAPAs (Corrective and Preventive Actions), Change Controls/MOCs (Management of Change), and other GMP documentation
Ensure timely closure of validation-related audit actions and commitments
Maintain validation documentation in a state of inspection readiness at all times
Qualification
Required
Bachelor of Science (BS) degree in a science-related field, engineering, or equivalent experience
Minimum of ten (10) years of validation experience within the pharmaceutical or medical device industry
Minimum of three (3) years of supervisory experience or demonstrated experience leading a validation team
Experience working in a cGMP (current Good Manufacturing Practice) manufacturing environment with a strong understanding of cGMP regulations and quality standards
Exceptional leadership and interpersonal skills
Excellent verbal and written communication skills, with strong analytical and organizational abilities to manage competing priorities in a team environment
Ability to prioritize, multitask, remain flexible to change, and respond with a sense of urgency
Proactive, highly energetic leader with a self-driven and motivated mindset, capable of working independently with minimal supervision
Demonstrated flexibility, adaptability, and self-motivation in response to changing conditions and schedules
Ability to develop strong relationships and lead teams to achieve results
Demonstrates self-control and professionalism when dealing with stressful situations
Enthusiasm for building a company with an outstanding work ethic and the ability to excel in a fast-paced, multi-product environment
Qualified to work with controlled substances
Preferred
Experience working in a CDMO (Contract Development and Manufacturing Organization) environment supporting multiple customers and concurrent projects
Experience with equipment, process, utility, and computerized system validation (CSV)
Experience with Six Sigma
Strong communication skills with the ability to interface effectively with customers and regulatory agencies
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
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2026-01-01
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