Manager, Validation Engineer

Kindeva•Lexington, KY

19h

About The Position

At Kindeva, we make products that save lives, ensuring better health and well-being for patients around the world.Our Work MattersAt Kindeva, we make products that save lives, ensuring better health and well-being for patients around the world. As a Validation Engineer Manager, you will lead and direct validation strategy across manufacturing processes, equipment, utilities, and computerized systems within a regulated pharmaceutical Contract Development and Manufacturing Organization (CDMO) environment. This role provides both technical and people leadership, ensuring validation activities are executed using a risk-based, science-driven approach aligned with current regulatory guidance and industry best practices. You will serve as a key liaison between Quality, Manufacturing, Engineering, Regulatory, Project Teams, and external customers, ensuring validation deliverables support operational readiness, inspection readiness, and business priorities. This is a highly visible leadership role requiring strong technical expertise, regulatory confidence, and the ability to guide and develop a high-performing validation team in a fast-paced, multi-product environment.

Requirements

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.

Nice To Haves

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.

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.