Validation Engineer

3 weeks ago

Minnetonka, United States Planet Pharma Full time

5-Month W2 Contract

$65-$75/Hour

POSITION SUMMARY:

This position leads validation and quality engineering activities for internally manufactured products, including validation plans, protocols and reports, maintenance of DMR, change control and CAPA/Deviation investigations. This position is the owner of the process validation system and is responsible for developing and maintaining procedures and policies in accordance with regulatory requirements and industry standards.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Responsibilities include, but are not limited to:

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/NCR/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?

EDUCATIONAL REQUIREMENTS (degree, license, certification):

Bachelor level degree in Engineering (Mechanical or Biomedical) or related Science

YEARS OF EXPERIENCE:

5-7 years relevant experience within medical device industry or related function

OTHER SKILLS AND ABILITIES:

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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