Validation Engineer

1 month ago

Minnetonka, United States Katalyst HealthCares & Life Sciences Full time

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.

Performs other related duties as assigned?

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.

Ability to manage multiple projects.

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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