Computer Systems Validation Engineer

LanceSoft Inc

Lexington, MA

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JOB DETAILS

SALARY

$50–$52.85 Per Hour

SKILLS

Bioengineering, Biology, Biotech and Pharmaceutical, Bug Tracking/Defect Management, Capital Project, Code of Federal Regulations, Communication Skills, Computer Skills, Computer Systems, Cross-Functional, Current Good Manufacturing Practice (cGMP), Data Mapping, Data Quality, Documentation, Funding, GCP (Good Clinical Practices), GMP (Good Manufacturing Practices), GxP, Identify Issues, Industry Standards, Information/Data Security (InfoSec), Laboratory Information Management System (LIMS), Labware, Maintain Compliance, Microsoft Product Family, Microsoft Project, Operational Expenditure (OPEX), Presentation/Verbal Skills, Project/Program Management, Quality Control, Regression Testing, Regulations, Regulatory Compliance, Regulatory Requirements, Requirements Management, Requirements Validation/Verification, Root Cause Analysis, Scripting (Scripting Languages), System Validation, Systems Engineering, Test Automation, Test Plan/Schedule, Test Scripts, Traceability, Trend Analysis, Validation Documentation, Validation Plan, Writing Skills

LOCATION

Lexington, MA

POSTED

5 days ago

Job Title: Computer Systems Validation Engineer/Specialist
We are looking for a validation engineer with experience in computer systems validation work with preference to those familiar with MODA and/or LabWare interfaces.
Technical duties include developing and implementing validation protocols, adhering to domestic and international GMP regulations. It also includes communicating with impact, operating collaboratively while holding themselves and other team members accountable and proactively taking steps to learn & grow based on feedback. The individual will collaborate with cross-functional team members such as Quality Systems, Quality Control, Project management and other technical disciplines to lead execution of assigned validation deliverables of the projects.

Experience essentials:

Bachelor s degree in a technical discipline, preferably engineering or biological sciences and a minimum of 5 years pharmaceutical and/or biopharmaceutical industry experience. Corresponding relevant experience in lieu of a bachelor's degree will be considered when assessing candidates.
Applies thorough understanding of cGXPs, GAMP5, S88 and 21CFR Part 11 (as applicable).
In-depth knowledge of core principles of validation programs
Regulatory Compliance: Understanding, adhering to and maintaining compliance with cGMP standards is fundamental. Position will navigate complex regulatory requirements to ensure that all changes to LIMS/MODA systems meet industry standards.
Experience in Trackwise, Veeva, Kneat, ALM or other common electronic documentation systems
Experience in Microsoft Teams operations
Strong written and verbal communication skills are desired.

Project-Specific Scope Details
Project 1 (Bioburden Alignment): The core deliverable is the transition of Master Data configuration in MODA to handle numeric values (>250/>50) instead of text-based "TNTC" flags. Support must ensure that existing trending reports do not break during this shift. This is an Opex project and will be funding via Quality
Project 2 (Growth Direct Interface): This requires specific deliverables for Data Integrity verification. The CSV support must prove that counts from the Growth Direct camera are accurately "mapped" to the corresponding sample record in MODA without manual entry. Liz to confirm with Tyler Zbinden if this project has capital funding that could be charged to.

Key CSV Deliverables & Activities:
Full Validation Lifecycle Management: Authoring and routing GAMP 5 documents, including Validation Plans, URS
Test Script Development (ALM): Designing and managing all manual and automated test scripts within Client ALM with full traceability.
Interface & Data Integrity Verification: Specifically validating the secure data mapping and transfer between the Growth Direct instrument and MODA.
Comprehensive Regression Testing: Ensuring that new method configurations and the instrument interface do not impact existing MODA functionality or data integrity.
Defect & Deviation Management: Managing root cause analysis and documentation for any issues identified during the execution phase.
Cross-Functional Coordination: Acting as the technical bridge between Business SMEs and Admin SMEs to translate requirements into validated system states.

About the Company

LanceSoft Inc

We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc).

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.

COMPANY SIZE

2,000 to 2,499 employees

INDUSTRY

Staffing/Employment Agencies

FOUNDED

2000

WEBSITE

http://www.lancesoft.com/