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Systems Manager - API

Facility:  Information Technology & Telecom
Location: 

Clayton, NC, US

About the Department                                                                                                                                             

At Novo Nordisk, we want to make a difference. For nearly 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world. Working at our Diabetes Active Pharmaceutical Ingredient (DAPI) manufacturing facility, you will help meet the growing demand for our treatments. Novo Nordisk expects to double production of diabetes and obesity products over the next decade; we have recently completed construction of a 825,000 sq. ft diabetes Active Pharmaceutical Ingredient (API) plant in Clayton, NC. Our new API facility houses the fermentation, recovery and purification of GLP1 ingredients for Novo Nordisk’s innovative oral products. Here, you will work with the best manufacturing professionals in the industry. Are you ready for a life-changing career?
 

Position Purpose

Manage the governance, provide project oversite, drive the schedule & ensure adherence to the documented requirements for system management of assigned IT Systems. This includes the full system lifecycle management process (system development, system maintenance & operation, compliance with regulatory & Novo Nordisk requirements, incident & change management & retirement of systems). Ensure processes are in place for system maintenance & operation according to relevant regulatory authorities (GxP, Financial, Personal Data Protection, etc.).

 

Accountabilities

  • Manages the IT system requirements by ensuring system compliance with relevant Standard Operating Procedures (SOPs) & guidelines, as well as external requirements (system security, audit trail, data integrity/retention/archival/restoration, patching, system monitoring, system continuity & contingency plan, etc.)
  • Works with IT Security/SME to ensure appropriate system security controls are in place & documented
  • Ensures appropriate validation approach & qualification testing is in place to ensure IT requirements are met (i.e. FAT, SAT, UAT, IQ, OQ, PQ and/or GEP)
  • Manages the system lifecycle process & provides strategic perspective for the IT roadmap
  • Manages system change control with a risk-based approach
  • Reviews & approves testing protocols to ensure requirements are tested appropriately
  • Manages the system configuration & supports determining the configurable items that are documented in the configuration baseline standards
  • Manages the system documentation (operation & maintenance standards, specifications, configuration baselines, instructional manuals, system architecture, data flows, system assessments, etc.)
  • Works closely with Subject Matter Expert (SME) to ensure system documentation complies with local, corporate & regulatory regulations
  • Ensures user training & user support are in place
  • Manages the approval of access for new users & performs user access reviews to determine access removal
  • Ensures continued & improved overall user satisfaction with system
  • Works with cross-functional project teams for process improvement
  • Works closely with SME to understand & determine solutions for IT incidents & deviations, to ensure effective corrective actions are identified & implemented to prevent incident recurrence
  • Supports establishing support standards & processes (internal & external support contracts/service level agreements (SLA), licensing contracts, incident handling, etc.)
  • Serves as primary escalation point for system support, improvements & projects
  • Ensures that the validated state is maintained & monitored according to the established requirements by managing the Periodic System Evaluations (PSE) & reviewing system data to ensure IT controls are actively functioning as designed to ensure compliance with the documented system requirements
  • Evaluates system alarms, user access, deviations & trends
  • Supports audits & inspections
  • Manages the project portfolio for the system (software upgrades, managing hardware obsolescence, retirement, etc.)
  • Maintains a safe work environment
  • Other accountabilities, as assigned

 

Required Qualifications

  • Expert in GxP documentation practices
  • Excellent oral & written communication skills
  • Experience in regulatory audits & inspections
  • Expert in planning/organizing critical path milestones & resource demands, developing detailed schedules, managing task execution, process confirming results, adapting to the agility of a production environment, working with cross functional teams & revising the work plan for unplanned complex problems

 

Desired Qualifications

  • BA/BS degree in computer science/engineering/related field, equivalent combination of experience & education, or 5 years pharmaceutical IT system management experience focusing on compliance
  • Minimum of five (5) years of engineering experience operation & maintenance of IT systems
  • Minimum of five (5) years of pharmaceutical industry experience (GxP)
  • Minimum of five (5) years of supporting & troubleshooting automation/IT systems & batch processes
  • Proficient at troubleshooting (systematic problem solving) automated/IT system issues, including interfaces & hardware components
  • Understanding of IT frameworks such as COBIT, ITIL, GAMP, 21CFR Part 11, &/or PIC/S Annex 11
  • Functional knowledge of API processes & batch sequencing
  • Expert in system development & lifecycle management including validation of computer systems, operation & maintenance & retirement
  • Functional understanding of the application of statistical analysis to problem solving

 

Physical & Other Requirements

  • Occasionally moves equipment and/or supplies weighing up to 33 pounds within the facility using various body positions
  • Constantly operates a computer & other office equipment using hands
  • Able to work in an open office environment with the possibility of frequent distraction
  • Able to work the hours necessary to support a 24/7 continuous manufacturing operation

 

Novo Nordisk is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.

 

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.