SHINE Technologies · 13 hours ago
Validation Engineer
Janesville, WI
Full-time
Onsite
Mid Level
$75K/yr - $90K/yr
3+ years expSHINE Technologies is seeking a Validation Engineer to ensure systems, processes, and products meet specified requirements and regulatory standards. The role involves developing and executing validation protocols, ensuring compliance with quality standards, and supporting validation activities in the commercial manufacturing facility.
BiotechnologyMedical DeviceEnergyHealthcareManufacturingPharmaceuticalHealth CareMedical
Responsibilities
Create and maintain validation protocols and reports, ensuring they align with regulatory requirements and project goals
Lead the development of risk assessments in relation to validation activities
Ensure validation activities are being performed in accordance with SHINE validation policies, procedures, and the Master Validation Plan
Coordinate and help execute approved protocols for process validation, equipment installation and operational qualification (IQ/OQ), performance qualification (PQ), and requalification/revalidation of critical systems and utilities
Provide input and guidance on new and existing validation projects including facility systems, manufacturing equipment and processes, analytical instrumentation, and cleaning processes
Ensure validation initiatives are adhering to specified timelines
Provide status and progress reports for validation/qualification activities or projects for the Management Review Meetings
Review FDA and EMA regulations to ensure the validation activities meet defined requirements
Assist in the development and preparation of protocols for process qualification, cleaning validation, equipment commissioning and qualification (including but not limited to FAT/SAT/IOQ and PQ) as well as CSV (Computer Software Validation) documentation to ensure data integrity requirements are met
Review and analyze analytical and physical data generated from executed validation/qualification activities
Write validation/qualification final reports that present, summarize and offer conclusions on the validity of the processes based on objective evidence, obtain necessary approvals
Prepare documentation and provide support for regulatory/compliance inspections
Perform periodic reviews of system(s) validation and reporting for the Annual Quality Product Review. Ensure appropriate plans are determined for gaps identified during periodic reviews
Work with Development, Manufacturing and Quality personnel to generate risk management deliverables for new projects, processes, and equipment (Preliminary Hazard Analysis Assessments, Criticality Assessments, System Impact Assessments, Risk Management Reports, Failure Mode and Effects Analysis)
Reviews proposed changes for impact to system qualification and validation. Identifies and completes requalification activities to support change completion
Working closely with cross-functional teams (e.g., R&D, Quality, Engineering, IT) to ensure alignment of validation activities with other project phases and deliverables
Collaborates with cross-functional teams to meet project objectives, timelines, including scheduling, qualification testing, and deviation resolution
Identifying opportunities for improvement in validation processes and procedures and implementing corrective actions
Qualification
Required
BS in scientific discipline or equivalent other work experience
Previous experience of 3-5 years in validation activities associated with pharmaceutical or medical device company is preferred
Experience in cGMP environments
Strong understanding of validation principles, methodologies, and regulatory requirements
Experience in drafting and executing qualification documents (IQ, OQ, PQ)
Ability to write procedures and protocols and review documentation
Ability to lead and motivate teams, manage projects, and communicate effectively
Ability to analyze data, identify risks, and develop effective solutions
Ability to identify and resolve issues related to validation and compliance
Excellent written and verbal communication skills for interacting with cross-functional teams and stakeholders
Benefits
Comprehensive compensation package
Company
SHINE Technologies
SHINE Technologies develops fusion technology to inspect industrial components, produce medical isotopes, and generate fusion energy.
201-500 employees
Funding
Current Stage
Growth StageTotal Funding
$774.21MKey Investors
ARPA-EGovernment of the NetherlandsUS Department of Energy
2025-02-24Series C
2025-01-17Grant
2024-10-17Grant
Leadership Team
Greg Piefer
Founder and CEO
Gregory Piefer
Founder and CEO
Recent News
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2026-01-03
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