Sr. Computer Systems Validation Engineer

Sr. Computer Systems Validation Engineer, Remote

• Contract
• Remote
• 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.
• 8-10 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 - ;/li>

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.