Skip to content

Job Openings

Validation Engineer

Minnetonka, MN 55343

Posted: 01/16/2024 Employment Type: Contract Job Category: Engineering Job Number: 594579 Is job remote?: No Country: United States

Job Description

Target PR Range: 65-75/hr
*Depending on exp

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

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

Apply Online

Send an email reminder to:

Share This Job:

Related Jobs:

Login to save this search and get notified of similar positions.

About Minnetonka, MN

Discover exciting job opportunities in the enchanting Minnetonka, Minnesota area! Embrace a thriving professional scene amidst the picturesque landscapes and vibrant culture this region has to offer. From the iconic Minnehaha Falls to the renowned Guthrie Theater, there's no shortage of attractions to explore during your off hours. Indulge in the local delicacies like Juicy Lucy burgers and explore the numerous art galleries and parks that make this area truly unique. Whether you're a sports enthusiast cheering for the Vikings at U.S. Bank Stadium or seeking tranquility in the stunning Lake Minnetonka, this region promises growth opportunities and a fulfilling career path. Start your journey today by exploring our latest job listings in Minnetonka, MN!

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.