Location: Clayton, NC
Company: Novo Nordisk
around the world. In NC, we operate three medical manufacturing facilities that are responsible for fulfilling different steps in our injectable and oral treatment supply chains. Our newer Active medical Ingredients (API) facility in Clayton, NC sits on 825,000 square-feet of state-of-the-art equipment, and houses the Fermentation, Recovery and Purification in the production of ingredients for Novo Nordisk’s innovative oral products.
At API, you’ll join a global network of manufacturing professionals who are passionate about what they do. What we offer you: Leading pay and annual performance bonus for all positions All employees enjoy generous paid time off including 14 paid holidays
Health Insurance, Dental Insurance, Vision Insurance – effective day one Guaranteed 8% 401K contribution plus individual company match option Family Focused Benefits including 12 weeks paid parental & 6 weeks paid family medical leave Free access to Novo Nordisk-marketed medical products Tuition Assistance – reimbursement Life & Disability Insurance Employee Referral Awards At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career.
Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters. The Position 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 (Gx P, Financial, Personal Data Protection, etc. ). Relationships Reports to Manager, Automation System Magement API. Essential Functions Manages the IT system requirements by ensuring system compliance with relevant 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 backssments, 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 Physical Requirements Moves equipment &/or supplies weighing up to 33 pounds within the facility using various body positions.
Ability to do close precision work with their hands. Must be able to remain in a stationary position (sitting and standing) 50% of the time. May required corrected vision to 20/25 based on role. May require color vision based on role. Occasionally ascends/descends a ladder. May be required to work at elevated heights. Occasionally works around odorous &/or hazardous materials. Qualifications BA/BS degree in computer science/engineering/related field, equivalent combination of experience & education, or 5 years medical IT system management experience focusing on compliance preferred Minimum of five (5) years of engineering experience operation & maintenance of IT systems preferred Minimum of five (5) years of medical industry experience (Gx P) preferred Minimum of five (5) years of supporting & troubleshooting automation/IT systems & batch processes is a plus Proficient at troubleshooting (systematic problem solving) automated/IT system issues, including interfaces & hardware components preferred Understanding of IT frameworks such as COBIT, ITIL, GAMP, 21CFR Part 11, &/or PIC/S Annex 11 is a plus Functional knowledge of API processes & batch sequencing is a plus Expert in system development & lifecycle management including validation of computer systems, operation & maintenance & retirement preferred Functional understanding of the application of statistical analysis to problem solving preferred Expert in Gx P documentation practices required Excellent oral & written communication skills required Experience in regulatory audits & inspections required 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 required We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in.
Together, we’re life changing. Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, interaction, gender identity, interactionual 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 -xyz X.
This contact is for accommodation requests only and cannot be used to inquire about the status of applications.
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