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Digital Lab Validation Engineer

 

A career with MilliporeSigma is an ongoing journey of discovery: our 58,000 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. 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.    

 

Job Title: Digital Labs Validation Engineer - Burlington, MA

 

A career with MilliporeSigma is an ongoing journey of discovery: our 58,000 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. 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: We are actively implementing a number of technologies across our laboratories worldwide.  To effectively implement these platforms, we are seeking a qualified Senior Validation Engineer to contribute to these efforts.  This newly created role will work with a high degree of autonomy to advance Life Science Digital initiatives.

 

The following are key responsibilities of a Digital lab Validation Engineer

 

  • Reporting to the Global Head of Digital for Operations, the Validation Engineer is responsible for the design and execution of validation programs and strategies to support the implementation various digitalization deployments into our Global network or manufacturing facilities.
  • The execution and completion of process, systems and equipment validations and revalidations in accordance with Validation Master Plans, schedules, and Company policy.

 

  • Prepare, execute and complete Validation Protocols and Reports, ensuring compliance to all relevant Quality Standards and Regulatory requirements.

 

  • Lead cross functional teams to establish and streamline validation strategies and objectives to support deployment of relevant digital deployments

 

  • Ensure all stakeholders understand and comply with the requirements of cGMP as applied to the validation program

 

  • Provide guidance and support to all departments/staff as needed regarding related issues, ensuring compliance, as applicable, with 21 CFR , ISO13485 and all other Quality Standards, Validation Regulations and Guidance Documents.
  • Manage system end user trainings.
  • Trains subject matter experts (SME’s) in the use of new functionalities and updated system configurations.
  • Develop analytical capabilities through which data collected or generated through the LIMS and DH may be leveraged for maximum business benefit.

 

  • Monitor the progress of validation projects on a daily/weekly basis ensuring that there is continuous drive/focus on meeting schedules.

 

  • Participate in the review of validation practices; monitor trends, and initiate improvement opportunities.  Escalate any out-of-norm matters to department management as applicable.

 

 

 

Who You Are:

 

 Minimum Qualifications:

  • Bachelor’s Degree in appropriate Quality Assurance/Science discipline

 

Preferred Qualifications:

 

  • At least 10 years relevant experience in a regulated environment
  • Good regulatory knowledge
  • Good verbal and written communication skills, including the ability to conduct verbal presentations.
  • Demonstrated success working in a team environment.
  • Ability to work under pressure to meet scheduled deadlines
  • Proven technical protocol and report writing skills
  • Ability to design and implement validation programs

 

 

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 https://jobs.vibrantm.com

 

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

 

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 https://jobs.vibrantm.com

 

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.

 

Job Requisition ID:  221128
Location:  Burlington
Career Level:  E - Professional (10+ years)
Working time model:  full-time

Careers during Covid-19
Thank you for visiting our careers website, we are always looking for curious minds to join our teams. We understand how much the world is being impacted by the Covid-19 crisis and we want to assure you that your safety is very important to us. To ensure that everyone’s health is protected, instead of a standard face-to-face interview, it is likely that you will be offered alternative digital interview options.

US Disclosure
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.

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.


Nearest Major Market: Boston

Job Segment: Developer, Laboratory, QA, Quality Assurance, Science, Technology, Quality

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