Sr. Computer Systems Validation Engineer

1 week ago


Wilmington, United States The ACI Group, Inc. Full time
Job DescriptionJob Description

Sr. Computer Systems Validation Engineer, Remote

  • Contract
  • Remote
  • Due to our government client requirements, we can only consider US Citizen or Green Card holders for this position
  • NO THIRD PARTY RECRUITERS PLEASE


KEYWORDS: Pharmaceutical, Computer Systems Validation

Description

Seeking a Sr. Computer Systems Validation Engineer to develop Computer System Validation strategies for testing/validation support for clients located throughout North America.

Responsibilities

  • Support in building CSV strategy for a newly developed computer system from scratch.
  • Prepare testing (without any previous versions); write test cases.
  • Collaborate on CSV change control and documentation for a Cloud Implemented System.
  • Provide CSV authoring, review and approval of validation documents developed by functional validation teams, ensuring the documentation meets regulatory requirements and quality standards.
  • Develop and manage GxP system lifecycle documentation, including Validation Plans, User Requirements Specifications, Functional and Design Specifications, Testing Protocols (IQ/OQ/PQ), Traceability matrix, Validation Reports, SOPs, Change Control Documentation, and Risk assessment reports.
  • Initiate/update GxP and Risk Assessments on system.
  • Author, review and or approve scheduled periodic reviews.
  • Author, initiate, and/or review and approve IT SOPs related to compliance.
  • Manage GxP projects across pharmaceutical, biotech and medical device systems such as ERP, LIMS, MES, CDMS, BMS, etc.
  • Manage and supervise teams.

Requirements

  • BS degree in Computer Science, IT, Biomedical, Pharmaceutical, Chemical or any other variety of engineering with years of experience in Information Technology and computer system Compliance and/or Validation.
  • 5-10 years experience in FDA regulated environment with strong understanding of cGxP standards and Risk based validation.
  • Hands-on experience developing requirements, test cases and procedures.
  • Experience with Lab equipment and Systems, LIMS, GLP or GMP, and knowledge of data integrity.
  • Knowledge of regulatory guidance's and industry standards (i.e., Quality Systems, GAMP, 21 CFR Part 11, Annex 11, ISO)
  • Experience in developing or reviewing system Validation Plans, Requirements, Design Specifications, Test Protocols, Deviation management, Traceability matrices and Validation Summary Reports.
  • Expertise in generating, reviewing, and addressing CAPAs.
  • Practical experience with Data Integrity and ALCOA+.
  • Competency with Project Management practices and techniques.
  • Strong attention to detail.
  • Experience with local and Cloud Implemented Systems.
  • Great interpersonal skills.
  • Excellent communication skills, written and verbal.
  • Experience with pharmaceutical, biotech and medical device systems such as ERP, LIMS, MES, CDMS, BMS, etc.

Desired

Prefer experience in some of the following focus areas:

  • ERP - NetSuite, SAP, MS Dynamics, other ERP Applications
  • EDC - REDCap, Medidata, other EDC applications
  • LIMS - LabCollector, Freezerworks, Labware, other LIMS application
  • Chromatography - Analyst, Empower, OpenLab, Chromeleon Other Chromatography Systems
  • Lab Systems - MDS, SoftMax, Quant Studio, general QC Laboratory Equipment Validation
  • Other - VisioPharm

Please Note:

  • Only those individuals selected for an interview will be contacted.
  • No calls, inquiries, or Third-Party Vendors please.
  • We are an equal opportunity employer (Unable to sponsor H1B Visas).
  • $1000 Referral Bonus - www.aci.com.

Since 1988, The ACI Group, a Baltimore-based staffing firm, has been committed to hiring the industry's leading professionals, and presenting exciting career opportunities. We have access to varied types of contract, permanent and contract-to-perm positions and offer a choice of employment options including a full benefits package.




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