Computer Science Validation

Job description

Computer Science Validation

A career with MilliporeSigma is an ongoing journey of discovery: our 50,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For 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 Computer Science position is on our Validation Team and will be the Data Integrity and Computerized Systems expert for the Validation Team that supports the manufacture of GMP pharmaceuticals. This Computer Science position will be the primary Computer Expert for the pharmaceutical manufacturing site.

Validation Personnel are recognized as a strong technical resource and quality presence. This position will be the Validation Team’s Computerized Systems Administrator for computer systems that belong to the team and is responsible for assisting with Data Integrity of computerized systems (Computers and associated analytical instruments such as spectrophotometers and chromatographs).  This position will also develop/review/approve validation testing for computerized systems.

Software/platform types that will be encountered in this role include (but are not limited to) DeltaV, SQL databases, WinUV software, and IFix. All systems are based on Windows operating systems within a cGMP Manufacturing Facility.

You will be interacting cross-functionally with Manufacturing, Project Management, Quality Control, Quality Assurance, Packaging, Materials Management, Engineering, and Maintenance. 

Main responsibilities will include the following:

·  Computer Administrator for the Validation Team’s Computerized Systems.
·  Data Integrity Expert for the Validation Team (21 CFR Part 11):
·  Assist with manufacturing site data integrity projects.
·  Ability to formulate and analyze software requirements.
·  Ability to determine the impact of proposed software and system changes to the current state of a computerized system.
·  Assist other validation personnel with the qualification of local PLCs on small equipment (e.g. Allen Bradly HMIs on reactors and cleaning skids).
·  Computer Science Validation:
·  Develop protocols to test computerized systems including features such as audit trail review, backup and restore functionality (Virtual & Physical Storage), and data analysis.
·  Develop protocols to document software, firmware and hardware upgrades to computerized systems and the impacts of the upgrades to the system.
·  Ability to review Design Documents for computerized systems.
·  Execute protocols for computerized systems.
·  Review and generate final reports (including any data analysis) for executed protocols.
·  Ability to utilize GDP during document creation and review.
·  Detailed oriented work standards.
·  Travel Requirements: rare (Travel outside of St. Louis maybe required for the execution of FAT’s. This time will amount to <2% of the work schedule).

Requirements: 

·  Minimum Experience:
·  Education:  PhD, B.S., or equivalent in a Computer Science, an Engineering discipline (e.g. electrical or computer), Mathematics or Physics. (Years in industry or certificates may be substituted based on experience.)
·  Familiarity with a programming language.
·  2+ years computer science experience.
·  Desired Experience:
·  Education:  PhD, B.S., or equivalent in a Computer Science, an Engineering discipline (e.g. electrical or computer), Mathematics or Physics. (Years in industry or certificates may be substituted based on experience.)
·  Experience with a programming language.
·  Any general working knowledge of a computer system architecture. (e.g. Client-Server, Networking / Communication, Virtual & Physical Storage & Application Servers).
·  Knowledge in GAMP requirements and interpretation to implement based on the software category in GxP manufacturing, quality control environment.
·  Ability to apply and incorporate standards, rules and guidances. (e.g. FDA, EU, ISO, ISPE, 21 CFR Part 11, etc.)
·  3+ years computer science experience.RSRMS

RSRMS

Job Requisition ID: 208217

Location: St. Louis

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

Working time model: full-time

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.

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