Product Documentation Specialist

Posted 14 Aug 2019

Burlington, Massachusetts - United States

Req Id 195914


A career with MilliporeSigma is an ongoing journey of discovery: our 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. MilliporeSigma is a business of Merck KGaA, Darmstadt, Germany.

Your Role:

This position is responsible for supporting technical leads during the development of new products.  Effectively communicate and coordinate with other internal disciplines routinely (design/drafting, engineering, molding, quality) and suppliers to execute the following tasks: Author product development documentation for the qualification and validation of new tooling, assembly processes, presses, and auxiliary equipment. Author, update and release using documentation system protocols and reports for tooling & mold validations (includes IQ, OQ, PQ, first article, FAT, SAT) Author, update and release using documentation system purchase specification documentation, including initiation of artwork, packaging, labeling, finished goods specification. Responsible for acquiring documents numbers and maintaining QDS document status sheet for project teams.  

Maintain revision control using documentation system. Review and evaluate data from qualifications and validations (Excel, Minitab) Responsible for the PDP-BSP process being the external tech communicator with the vendor, and the internal tech leadership between Applications, Quality, Regulatory, Project Management, Product Management

10% travel will be required


Who You Are:

Minimum Qualifications:

  • Bachelor’s degree in a Science or Engineering discipline or 2+ years of engineering work experience
  • 2+ years of experience writing validation protocols and reports
  • 1+ of experience working with Microsoft Word, Excel, Project and Minitab


Preferred Qualifications:

  • Experience with laboratory disposable devices and application
  • Experience in a medical device manufacturing environment
  • Understand and demonstrate use of control charts, and other quality support measures
  • Knowledgeable in the use of inspection equipment such as calipers, micrometers, pin gauges and other essential measurement tools
  • Strong verbal and communication skills
  • Well-developed skills in decision making and problem solving
  • Good organization skills
  • Ability to work independently, as well as in a team environment
  • CAD experience is desirable
  • Ability to work on multiple projects simultaneously

What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

Curious? Apply and find more information at

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.

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