Validation Engineer III

Posté 12 mars 2022

Jaffrey, New Hampshire - United States

Demander un identifiant 243158

Détails

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Your Role:

In our Jaffrey device manufacturing facility, part of the Separations Technology cluster, we are seeking a talented Validation Engineer to support the execution and development of the raw material and equipment validation projects. This full time, regular position is based in Jaffrey, New Hampshire. 

Mission:

You will be in responsible for developing and executing raw material and equipment validation projects with a quality focus and risk based approach. You will interact on a daily basis and develop strong relationships with Operations, Quality, Process Engineering, Planning, QC Laboratories, and other key internal/external stakeholders (Separations Technology, R&D, Supply Chain, etc.). 

Responsibilities:

  • Generate and execute validation protocols (Feasibility, OQ, PQ, PDQ) for various raw material and equipment changes impacting EMD Millipore’s Jaffrey Facility. 
  • Develop validation strategy, protocols, and reports with a risk based approach in alignment with the established critical process controls for product validation, process validation, and applicable cleaning validation activities.
  • Perform and facilitate raw material change and new equipment risk assessments.
  • Manage project schedules with strict adherence to critical milestones to ensure quality and security of supply to EMD Millipore customers.  Manage escalation of any issues that could present a risk to EMD Millipore customers or the project. 
  • Provide clear, frequent and effective communication to project team members and key stakeholders in a matrix environment.
  • Help create validation tools to standardize approach by topic and reduce non-value added activities
  • Coach and mentor new and junior members of the team.

 

Who You Are:

Minimum Qualifications:

  • Bachelor’s Degree in Engineering or Science.
  • 4+ years of engineering experience in a manufacturing and/or R&D based organization.
  • Experience in project management of technical projects and delivering them to a successful conclusion within a matrix organization.
  • Familiarity with EH&S, ISO, cGMP, and other regulatory requirements in a manufacturing environment. 

 

Preferred Qualifications:

  • Be passionate about the quality of product delivered to customers.
  • Be energized by working in a fast-paced regulated manufacturing environment where attention to detail and documentation are critical.
  • Recognize the importance of building and maintaining strong interpersonal relationships.
  • Be self-motivated.  Proactively identify opportunities and solutions with minimal oversight.
  • Experience with Microsoft Project desired.

 

 

 

 RSRMS

 

 


The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

 

As an employee of the Company, you will be required to comply with all of the Company’s COVID-19 safety protocols and policies. The organization has currently suspended enforcement of its COVID-19 Vaccination Policy, but that policy may be reinstated by the Company in its discretion.

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