Sr. Computer Systems Validation Engineer
2 weeks ago
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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