Quality Computer Systems Engineer

Revance • Johnson City, TN

1d • Onsite

About The Position

The Quality Computer Systems Engineer will create and execute Computer System Validation (CSV) protocols for key projects that impact quality systems. They will support the maintenance of the site Master Validation Plan and facilitate critical CSV planning.

Reporting to: Quality Assurance Manager - Technical Services
Location: Johnson City, TN - onsite
Schedule: Monday - Friday, 8:00am - 5:00pm

Requirements

• Bachelor's degree & 3+ years' directly related experience
• Progressive experience in a related role within a cGMP environment with working knowledge of CFR 210, 211, 820 and 21 CFR Part 11 is preferred
• Familiar with ISPE, GAMP and system life cycle deliverables

Nice To Haves

• Bachelor's Degree preferably in computer science, scientific or engineering disciplines
• Candidates knowledgeable in advanced LIMS and ERP systems may possess suitable skill sets that can be adapted to support CSV
• Experiences with Serialization, LIMS, Agilent OpenLAB, elnfotree, LORENZ docuBridge, Reliance, Salesforce, and electronic Batch Records and varied computer-assisted equipment or similar is desired

Responsibilities

• Assist URS creation and support of SRS and FRS testing and review
• Ability to create and/or manage VP, CS, IQ, OQ, PQ, RTM and applicable support controls to assure on-time completion of CSV projects and meeting all compliance requirements
• Aid with developing procedural controls to assure continued system maintenance and compliance
• Can assess critical, major, and minor changes to key quality systems to determine appropriate qualification requirements to support the Change Control System
• Can create computerized systems Risk Assessment reports
• Can conduct system audits and as applicable provide gap assessment planning
• Knowledge of networking principles practices and technologies as well as cloud-based systems architecture are helpful to support IT team members for interfaced software undergoing validation
• Excels in compiling multiple forms of communications, describing the completed computerized system, simplifying and organizing the given information to create test planning with justifications for how the system will be tested, writing test steps for positively and negativity testing the system utilizing applicable user roles, and then documenting in cGDP format for each tested scenario
• Creating a RTM for this testing to assure system control and compliance
• Summarizing the collected testing data and including any deviation for required corrective action, review, and approval
• Ability to problem solve and to be able to fully participate in diverse cross functional teams to achieve the business objectives
• Excellent written and verbal communications skills. A service-centered, team building attitude
• Ability to handle multiple tasks simultaneously, having good planning and organizational skills
• Strong proficiency in Microsoft Office suite of products and having experience with application software and equipment control systems hardware/software/firmware with the ability to navigate and document varied human-machine interfaces

Benefits

• Competitive Compensation including base salary and annual performance bonus
• Flexible PTO, holidays, and parental leave
• Generous healthcare benefits, HSA match, 401k match, employer paid life and disability insurance, pet insurance, wellness discounts and much more!

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 251-500 employees