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Validation Engineer - Hopkins, United States - Katalyst HealthCares & Life Sciences
Description
Responsibilities:
Develop validation plans, protocols and reports for assembly and packaging processes
Develop and manage validation standard operating procedures in compliance with regulatory requirements
Develop and maintain validation protocol and report templates
Develop test method validation (TMV) protocols and reports for automated and manual inspection methods
Provide quality engineering support for semi-manual and automated equipment development
Review equipment URS, FAT/SAT against quality requirements
Support design transfer of internal manufacturing processes
Perform statistical analysis of validation and production data
Supports manufacturing process development & qualification for product changes
Identifies and supports continuous improvements
Leads CAPA/Client/SCAR investigations and reports
Supports internal & external audit
Supports complaint investigations
Supports quality system development as required
Reviews supplier documentation in accordance with established requirements
Responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs.
Bachelor level degree in Engineering (Mechanical or Biomedical) or related Science.
Requirements:
Knowledge of GMP, ISO, QSR and other applicable international regulations, standards, Directives and Guidance.
Good statistical data analysis skills (Minitab).
Lead auditor certification preferred.
Design for Six Sigma and Critical to Quality training and experience a plus.
Background in manufacturing processes for sterile pharmaceutical products and drug-device combination products related to development and commercial programs a plus.
Excellent verbal and written skills.
Able to work independently, as well as in a team environment.
Customer focused and service oriented.
Ability to educate stakeholders, customers and management.
Ability to interface with internal customers, 3rd-party partners, Health care providers. (HCPs) and regulatory agencies.
Experienced working with cross-functional teams.
Excellent communication skills (verbal and written).
Experienced with participation in audits.
ASQ certification a plus.
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