QC Automation Engineer I - Laboratory Systems - OFP
Novo Nordisk
About the Department
For more than 100 years, Novo Nordisk has been tackling the unmet medical needs of people living with serious chronic diseases, such as diabetes & obesity. 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.
In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable and oral treatment supply chains. Our Emerging Technologies - Oral Finished Products facility in Durham, NC is a 194,000 square foot tableting and packaging facility that supports the production of our innovative oral treatments for patients with type 2 diabetes. OFP maintains a curious and pioneering spirit, harmonious with our growing pipeline of new products and emerging technologies.
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 pharmaceutical products
+ Tuition Assistance
+ 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
The QC Automation Engineer role will provide support & management of hardware & software on quality control laboratory computer systems. This includes improving reliability of the QC lab computer systems to meet current & projected customer, business & regulatory requirements through the following activities: People Focus, Equipment Focus & Standards "Gatekeeper". Quality Control and LIMS software experience is highly desirable.
Relationships
Quality Control Senior Manager.
Essential Functions
+ Support plans to maintain & improve QC lab computer systems
+ Operate as automation resource on projects that involve QC lab computer systems
+ Meets project milestones per project plans & communicates challenges early
+ Communicate with team & management on issues & provides timely updates
+ Own self development & initiative to understand the QC lab computer systems
+ Adhere to the automation/IT standards & implement the necessary changes to the automation/IT-related specifications & maintenance plans
+ System assessments & testing of operating systems, software, & hardware
+ Perform system assessments & testing of operating systems, software, & hardware
+ Perform automation/IT validation activities in accordance with Novo Nordisk procedures & FDA 21 CFR Part 11 requirements
+ Support audits & inspections as SME for QC lab computer systems
+ Coach & train colleagues & stakeholders in relevant areas
+ Utilize the appropriate cLEAN® tools within the main areas of Systematic Problem Solving, process improvement, & project management
+ Operate within compliance with a Quality Mindset that focuses on risk management & mitigation
+ Support effective Change Management
+ Support Corporate, OFP, local IT & local stakeholder initiatives & projects
+ Govern behavior based on the Novo Nordisk Way
+ Follow all safety and environmental requirements in the performance of duties
+ Other duties as assigned
Physical Requirements
May move equipment &/or supplies weighing up to 33 pounds within the facility using various body positions. May be required to be on your feet for up to a 12-hour shift. May required corrected vision to 20/20 or 20/25 based on role. May require color vision based on role. May require the ability to work in loud noise environments with hearing protections.
Qualifications
+ Bachelor's degree in engineering, computer science or related field of study from an accredited university is required
+ May consider Associate’s degree from an accredited university in engineering, computer science or related field with 6 years of relevant experience
+ May consider a High School Diploma or GED with 8 years of relevant experience
+ Minimum of two (2) years of automation/IT experience with lab systems or process-based manufacturing systems preferred
+ Knowledgeable in the following systems: Windows operating systems, Active Directory User, Groups & Computer Management, Empower, LIMS, MS SQL preferred
+ Proven expertise, (e.g. project management) in planning/organization & project execution, follow-up & completion preferred
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, 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.
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