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Validation Project Manager

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Date: Jun 29, 2019

Location: Ballina, MO, IE

Company: Hollister Incorporated

We Make Life More Rewarding and Dignified

Location: Ballina Office 
Department: Quality 

  • HOLLISTER INCORPORATED - POSITION DESCRIPTION

  •  

     

    Title

    Validation Project Manager - Ballina

     

    II.        SUMMARY

     

    The Global Quality Assurance organization contributes to the achievement of the Mission by

    consistently delivering market-required "First Class" quality products. 

     

    To support this Mission, there is requirement to ensure efficient execution of New Product

    Development, Change Controls, Design Improvement and Capacity projects.

    The Validation Project Manager will be responsible for validation strategy and documentation approval. They will also be responsible for resource assignment and development of the validation team.  

     

     

    III.       RESPONSIBILTIES

     

  • Developing Validation best practices, standards and guidelines which includes exploring new techniques, methods and other industry practices.
  • Develop validation plans, timelines and cost breakdowns based on project milestones.
  • Reviews and approves Validation protocols and summary reports generated by the Validation staff against standard operating procedures and policies as well provides guidance to Validation staff writing protocols and final reports.
  • Leads projects by developing appropriate plans, schedules, resource loading and other project deliverables as required
  • Manage a team of validation engineers/technicians and establish individual development targets and handle annual performance reviews with team members
  • Collaborate with Engineering Managers and Engineers to verify and develop validation setup and procedures
  • Coordinate external validation with contract houses as required
  • Provides leadership in change management & in risk assessment, specifically process risk and capability analyses on processes
  • Provides leadership in facilitating internal and external audits and completes internal audits as per audit schedule
  • Ensures training to FDA good manufacturing practices and ISO quality standards (including defect recognition)

     

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    IV.       ESSENTIAL EXPERIENCE

     

  • Validation experience to Industry standards
  • Problem Solving and Analyzing
  • Project Managing (includes AFE process)
  • Fiscal Managing (includes budget preparation)
  • Personnel Staffing and leading a team
  • Goal Setting
  • Strong Communication
  • Improvement of Processes and Process Control

 

V.        QUALIFICATIONS 

 

  • B.S. or B.A. in Physical Science, Engineering, or other related discipline
  • 10 years quality engineering experience especially in Validation sector, including previous supervisory experience
  • Knowledge of applicable foreign and domestic regulations
  • Knowledge of process validation techniques
  • Knowledge of quality engineering tools and statistical quality control techniques
  • Knowledge of project management skills
  • Knowledge of quality auditing techniques
  • Basic knowledge of sterilization

 


Hollister Incorporated is an independent, employee-owned company that develops, manufactures, and markets products for ostomy care, continence care, and wound care and develops educational support for patients and healthcare professionals. We have been in business for more than 95 years. Our products are sold in more than 90 countries and we have manufacturing and distribution centers on three continents. At Hollister Incorporated, we are passionate about the work we do, and we are committed to making life more rewarding and dignified for our Associates and for the people who use our products and services. A career at Hollister Incorporated can take many paths, all of them leading to rewarding opportunities.

 

Hollister is an EO employer - M/F/Veteran/Disability

Job Req ID: 27320


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