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.
This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.
At MilliporeSigma, the Computer Science - Validation Engineer I position will be the Data Integrity and Computerized Systems expert for the Validation Team. This role supports the manufacturing of pharmaceuticals in a cGMP manufacturing facility.
Who You Are:Minimum Qualifications:
- Develop, review, and approvevalidation testing for computerized systemsin conjunction with other validation team members
- Work cross-functionally with Manufacturing, Project Management,Quality Control, Quality Assurance, Packaging, Materials Management, Engineering,Information Technology (IT),and Maintenance
- Understand and test software platforms and configurations for back-up applications
- Formulate and analyze software requirements
- Review design documents
- Determine the impact of proposedsoftware and systemchanges to thecurrentstateof a computerized system
- Assist other validationpersonnelwith the qualificationoflocal PLCs on small equipment (e.g. Allen Bradly HMIs on reactors and cleaning skids)
- Develop protocols to test computerizedsystemsincluding features such as: audit trail review,backupand restore functionality(Virtual & Physical Storage), and data analysis
- Develop protocolsto document software, firmware and hardwareupgradestocomputerized systemsand the impacts of the upgrades to the system
- Execute protocols for computerized systems, review and generatefinalreportsfor executed protocols
- Bachelor's Degree in Information Technology, Computer Science, or related technical discipline with 2+ years of IT Admin or Server Operations experience
- HS Diploma or GED equivalent with 6+ years of IT Admin or Server Operations experience
- Master's Degree or higher in Information Technology, Computer Science, or related technical discipline
- Experience with LIMS, DeltaV, SQL databases, WinUV software, and or IFix
- Working knowledge of computer system architecture such as Client-Server Networking, Virtual and Physical storage, and or Application Servers
- Knowledge of GAMP requirements and interpretation to implement based on the software category in GxP manufacturing, quality control environments
- Ability to incorporate and/or apply regulatory standards, rules, and guidance, such as: FDA, EU, ISO, ISPE, 21 CFR Part 11, etc
RSRMSWhat 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: 221508
Location: St. Louis
Career Level: C - Professional (1-3 years)
Working time model: full-time
This job has expired.