Computer Systems Validation Specialist
MilliporeSigma

Rockville, Maryland

Posted in Science and Research


This job has expired.

Job Info


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:

You will be responsible for the guidance and direction of validation projects covering all the Process Solutions Services digital products, applications, and computerized systems.

You will provide expert guidance on all aspects of computerized systems validation and will need to directly assist individuals/site requiring specific support for a limited time during regulatory inspections and/or large projects. You will review and become an expert in the regulatory guidelines as well as being current on potential changes which may impact the validation requirements. You will also provide expert guidance during regulatory audits and will provide project management support for projects which don't have site specific support systems in place.

The main responsibilities include (but are not limited to):

  • Computerized systems / digital products/ Control Systems/ Software / OT (Operational Technology - industrial software) / Cloud based solutions, IT Validation (IQ,OQ,PQ, Test Scripts, Protocols, Infrastructure qualification protocols, back-up restoration testing, audit trail testing) / quality assurance, Validation Master Plan meeting GAMP, QMS (Quality Management Systems), PDP (Product Development Process) and regulatory requirements based on the systems need/scope of target market and internal/external use in GMP area
  • Perform 21 CFR Part 11, Annex 11, Risk Assessments, Functional risk assessments, Data Integrity Assessments, FMEA to ensure the requirements, controls are captured prior to development and ensure tested system/products met those requirements. Including ability to review URS, Functional Spec, Design Spec, Test Scripts, User Manual for computerized systems, digital products, software applications (for both COTS and new products/solutions for target markets)
  • Develop Test Summary Report, Traceability Matrix, Validation Summary Reports, and management of deviations and observations
  • Operational Change Control, including customer complaints handling, periodic review and re-validation of multiple digital products / software applications. Actively participating as auditee presenting / explaining validation and qualification documents / reports to the regulatory, customer auditors and internal / external auditors

Who You Are:

Minimum Qualifications:
  • Bachelor's degree in any discipline
  • 5+ years of validations experience including but not limited to computerized systems, IT applications, and new digital product validation
  • 5+ years' experience with GMPs, GCPs, GLPs, GAMP and Part 11 compliance as they relate to qualification of systems in support of validation of processes

Preferred Qualifications:
  • Degree in a Scientific or Engineering discipline
  • Excellent fundamental project management skills: planning, organizing, attention to detail, managing competing priorities, analytical and systems thinking
  • Clear communicator, able to explain requirements, standards and project status updates
  • Comfortable in a fast-paced environment with the ability to adjust to changing priorities
  • Curiosity and drive to succeed, individually and as a team; willingness to learn and lead by doing

RSRMS

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: 221840

Location: Rockville

Career Level: D - Professional (4-9 years)

Working time model: full-time


This job has expired.

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