PLASTIKON HEALTHCARE, LLC · 4 days ago
Senior Validation Specialist
Lawrence, KS
Full-time
Onsite
Senior Level
$105K/yr - $125K/yr
5+ years expPlastikon Healthcare is looking for a Senior Validation Specialist responsible for generation and executions of all processes, equipment changes, and implementation of new systems, equipment, and product transfers. This position will lead all Process Validations providing critical documented evidence that a manufacturing process consistently produces a product that meets predetermined specifications.
Medical Device
Hiring Manager
Kari Lambert
Responsibilities
Develop and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for manufacturing and laboratory equipment
Provide technical expertise to define approaches and execution of system validation activities in accordance with cGMP, cGXP, CFR 21 Parts, 11, 210 & 211, EU Annex 11, ICH Q7, Q8 & Q9, and other applicable regulations, procedures, and industry guidelines
Provide engineering support for new equipment upgrades and special projects
Develop project plans and schedules; estimate time; track project progression
Participates in developments/ improvements to validation programs as needed to remain current with cGMPs and industry standards
Report on project progress, limiting factors and issues, changes in project scope, develop contingency plans, and resolve issues impeding progress
Collaborate with production personnel to develop new projects, identify limiting factors in current projects, and create/maintain relationships
Participates in teams assembled to specify, install, validate, troubleshoot, and maintain systems and equipment
Participates in deviation investigations to help identify root causes and define corrective and/or preventative actions (CAPA)
Write, review, and execute protocols
Ability to interpret and relate Quality and Best Practice Qualification and Validation standards for implementation and review
IQ/OQ/PQ activities for facilities/utilities
Ability to work individually and within a team environment
Comply with all company Environmental Health and Safety and Department of Health requirements
Other duties as assigned
Qualification
Required
BS in Engineering or in another discipline with equivalent experience
5+ years hands-on experience with facility validation, processes, and systems
Excellent attention to detail and working knowledge of FDA Regulations/Guidance and/or Good Manufacturing Practices
P&ID reading, commissioning and qualification principles, ISO Systems
Technical knowledge and experience with validation/qualification of processes, equipment, utilities, facilities and/or computer systems
Required reading, writing, and speaking fluently in English
Preferred
ISO execution
Quality Systems
commissioning and qualification preferred and is used to determine job level (I-IV)
Company
PLASTIKON HEALTHCARE, LLC
PLASTIKON HEALTHCARE, LLC is a company based out of 3780 GREENWAY CIR, Lawrence, Kansas, United States.
51-200 employees
H1B Sponsorship
PLASTIKON HEALTHCARE, LLC 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 (1)
2024 (1)
2023 (2)
2021 (2)
Funding
Current Stage
Growth StageCompany data provided by crunchbase