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Senior Computer Systems Validation Specialist

St Louis, MO 63146

Posted: 08/14/2023 Job Number: RB676048814

Job Description

Senior Computer Systems Validation Specialist Scope of Position:  The Senior Computer Systems Validation Specialist position shall provide validation support for computerized systems, software, and IT infrastructure that have been newly installed, upgraded, replaced and / or modified in a cGMP Manufacturing Facility as well as its related support areas, which may include Facilities / Engineering, Quality Assurance, Supply Chain, and Quality Control.  Essential Functions:   
  • Author, review and/or approve cGMP risk assessments, user requirements and functional specifications, validation plans, qualification test protocols (i.e. IQ, OQ, PQ), reports, addendums and other validation efforts as required.  
  • Managing and coordinating all aspects of the computer systems validation activities as they pertain to SDLC, including project planning, developing validation strategies, document development and document reviews.  
  • Evaluate and advise the system owner with recommendations for appropriate user roles and privileges for data integrity, writing instrument operation instructions and preventive maintenance plans.  
  • Ensure adherence to national and international regulatory guidelines on Electronic Records and Electronic Signatures and Data Integrity, cGMP, FDA 21 CFR Part 11/210/211, EU Annex 11, MHRA and GAMP5 guidelines.  
  • Author protocol to challenge the main aspects of regulatory requirements during validation to demonstrate adherence. For systems found unable to fully comply, develop solutions with core stake holders to mitigate the gaps.  
  • Act as validation representative for instruments and Subject Matter Expert for Tech Transfers.  
  • Partner with Laboratories end-users, System Administrators and the Quality Department on implementation of new instruments.  
  • Perform analytical instrument validation which may include, but not limited to, computerized system validation.  
  • Provide end-user support for all Quality Laboratory groups as well as maintains compliance to global and site internal policies and procedures.  
  • Assist the system owner with evaluating and recommending the appropriate user roles, writing instrument operation instructions, amongst other tasks.  
  • Review and approve validation deliverables created by others for adherence to site validation SOPs.  
  • Initiate/Review and lead change control for implementation of new instruments or changes to existing analytical instrumentation and associated instrument control software.  
  • Initiate and lead risk assessment, gap analysis, and deviation management associated with validation of lab instruments.  
  • Complete periodic reviews of cGMP systems, instruments and instrument control software with focus on change control, deviation investigations, and CAPA to ensure compliance and validated state.   
Requirements:   
  • Bachelor Degree in a Science or Engineering related discipline or equivalent experience required. 
  • 5 to 8 years of experience in the laboratory instrument validation field including those with computerized systems attached in a cGMP environment required.  
  • 5 to 8 years of experience in the pharmaceutical industry or relevant business experience within Quality Control or Validation cGMP Compliance.  
  • Experience operating / maintaining instrument systems including Gamma / Alpha Spectroscopy related to Canberra / Mirion Instrumentation preferred.  
  • Demonstrated attention to detail, good oral and written communication skills.  
  • Must be able to work independently as well as part of a group environment as required.  
  • Proficiency with core computer software/systems (Word, Excel, Project, SharePoint, etc.).  
  • Demonstrated ability to work in a team environment and manage workload to meet deadlines.  
  • Ability to follow instructions in written, oral, diagram, or schedule form.  
  • Willingness and interest in learning new skills.  
  • Willing to travel.   
 

Additional Information

Envision, LLC is proud to be an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

Meet Your Recruiter

Joe Migdal

Open minded individual with a background in sales and marketing. Golfed professionally all over the world from 2015-2018. Golfing has provided me with the discipline required in today's workforce to take each challenge thrown at me and give it my all. I am always open to new opportunities and to network with individuals in my area. Currently working as an Senior IT Staffing Consultant at Envision LLC.

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