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.

Requirements

• Bachelor’s degree and 3+ years’ directly related experience.

Nice To Haves

• Bachelor’s degree in computer science, scientific, or engineering discipline.
• Progressive experience in a related role within a cGMP environment, with working knowledge of CFR 210, 211, 820, and 21 CFR Part 11.
• Familiar with ISPE, GAMP, and system life cycle deliverables.
• Ability to problem-solve and fully participate in diverse cross-functional teams to achieve business objectives.
• Excellent written and verbal communication 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.
• Experiences with Serialization, LIMS, Agilent OpenLAB, eInfotree, LORENZ docuBridge, Reliance, Salesforce, and electronic Batch Records, and varied computer-assisted equipment, or similar.
• 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.
• Candidates knowledgeable in advanced LIMS and ERP systems may possess suitable skill sets that can be adapted to support CSV.

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 meet all compliance requirements.
• Aid with developing procedural controls to ensure continued system maintenance and compliance.
• Assess critical, major, and minor changes to key quality systems to determine appropriate qualification requirements to support the Change Control System.
• Create computerized systems Risk Assessment reports.
• Conduct system audits, and as applicable, provide gap assessment planning.
• Compile 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 scripts for positively and negatively testing the system utilizing applicable user roles, and then documenting in cGDP format for each tested scenario.
• Create an RTM for this testing to assure system control and compliance.
• Summarize the collected testing data and including any deviation for required corrective action, review, and approval.

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