Quality Computer Systems Engineer

Job Summary:

TheQuality 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

Responsibilities/Essential Duties:

• 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.
  
  
  
  

Basic Qualifications:

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

Preferred Qualifications:

• 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.

Company Summary:

Crown is a proud member of the Revance Portfolio of skincare offerings. Revance is a fast-growing global aesthetics and skincare company focused on providing innovative aesthetics and market-leading skincare offerings throughout every stage of life. With a differentiated portfolio of products spanning 60 countries, Revance meets the evolving needs of patients and consumers worldwide through continued innovation and commercialization of new products and treatments.

What Revance invests in you:

• 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!

Work Environment & Physical Requirements

This position requires extended periods of standing and walking on a manufacturing floor environment. Protective equipment (safety glasses, hearing protection, gowning) must be worn as required. The role operates in a temperature-controlled pharmaceutical manufacturing facility. Occasional lifting of up to 30 lbs may be required. Must be available to respond to critical shift issues outside of scheduled hours on an as-needed basis.

This section of the job description is required by the American with Disability Act (ADA). The ADA requires that job descriptions reflect the physical and mental demands required to effectively perform the essential duties of the job. The ADA prohibits employers from discriminating against a "qualified individual with a disability" in all aspects of the employment relationship. A "qualified individual with a disability" is "an individual who meets the education, experience, skill, and other job-related requirements of a position held or desired, and who, with reasonable accommodation, can perform the essential functions of a specified job."

Revance is an Equal Opportunity employer. All qualified applicants will receive consideration for employment based on merit, without regard to race, color, religion, sex, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.