Computer Systems Validation Engineer

Merck KGaA
Maryland Line, MD
Jan 18, 2022
Jan 20, 2022
Full Time
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. US employees must be fully vaccinated against COVID-19 prior to your start date unless an accommodation is granted by The Company. The Company uses the definition of "fully vaccinated" assigned by the Centers for Disease Control & Prevention for purposes of considering satisfaction of this requirement which is a condition of employment.Your Role: You will be responsible for the guidance and direction of validation projects covering all the Process Solutions Services digital products, applications, and computerized systems. We are looking for a bright and motivated engineer with strong attention to detail, excellent analytical and critical thinking skills, strong IT aptitude, and the ability to communicate effectively. The main responsibilities include (but are not limited to): Draft and execute Computer System Validation (CSV) documentation Validation Project PlanRequirement Specification (URS, DS, FS)IQ and OQ Test ScriptsIQ/OQ/PQ Protocols, as necessaryTraceability Matrix (TMX)System Release MemoValidation Summary ReportAuthor, review, and approve validation documents developed by functional validation teams, ensuring documentation meets regulatory requirements and quality standardsInitiate and update GxP and Risk Assessments on systemsAuthor, review, and approve scheduled periodic reviewsAuthor, initiate, and review/approve IT SOPsCollaborate with project stakeholders and the information systems teams to define requirements, achievable solutions, and justifications to system requirementsTranslate system requirement specifications into executable validation protocolsProvide support to executors of the protocols when neededWrite reports summarizing system validationProvide general support to validation engineering team and other functional teams, as neededWho You Are: Minimum Qualifications: Bachelor's degree in a scientific (ie, Biology, Chemistry, etc.) or engineering (ie, Computer Systems, Chemical, etc.)discipline5+ years experience in an automation, engineering, Project management or Operations role within a cGMP environment Preferred Qualifications: Excellent fundamental project management skills: planning, organizing, attention to detail, managing competing priorities, analytical and systems thinkingExperience with GMPs, GCPs, GLPs, GAMP and Part 11 compliance as they relate to qualification of systems in support of validation of processesClear communicator, able to explain requirements, standards and project status updatesComfortable in a fast-paced environment with the ability to adjust to changing prioritiesCuriosity and drive to succeed, individually and as a team; willingness to learn and lead by doingRSRMSWhat 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!Our Benefits - -at-a-Glance/?locale=en_USCurious? Apply and find more information at https://jobs.vibrantm.comIf you are a resident of a Connecticut or Colorado, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request. You may contact 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday, for assistance.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.