US-NC, Project Manager 2 - IT & Automation Job 427093300A0-MZ
|Requisition ID 49816BR|
Title Project Manager 2 - IT & Automation
Job Category Information Technology
Job Description Position Purpose:
Primary responsibility is to provide project management services for new IT & automation projects & processes. Scope of projects includes computer systems, facility, utility, equipment & processes associated with the production of insulin products.
Project management includes the following activities:
* Providing technical input regarding requirements & design
* Developing time & resource estimates to complete projects
* Evaluate select & coordinate contract resources
* Prepare validation plans to ensure validation activities are in accordance with applicable FDA, EU & NN requirements
* Actively manage portfolio of projects & budgets to ensure projects are completed on time & on budget
* Create & develop the project plan with effective & transparent systems, structures & processes
* Monitor & control project work with stringent follow-up on quality, schedule & budget so that the project delivers the desired end-product
* Provide clear goals & purpose for the project & the project team members so that the project secures effective use of time & resources & builds employee motivation
* Ensure that the right amount of resources & competences is allocated to the project, negotiate project resources with Line of Business (LoB) management & manage these resources during project execution
* Report project performance to the relevant stakeholders
* Perform integrated change control on the project
* Archive all key project & test documentation in compliance with good documentation practices
* Ensure that completed projects embedded in the organization & implemented with measurable results
* Ensure alignment with Global programs & all other running IT projects
* Actively share best practice, knowledge, & visions cross site in PS
* Leads project activities associated with large, medium sized projects.
* Creates master plans for projects that outline all required activities associated with the projects.
* Develop timelines & resource estimates to complete projects.
* Requires no guidance & direction to complete these goals & needs no coaching or technical competencies for goal obtainment. Serves as a source of expertise in the group for projects.
* Completes projects within schedule & budgetary constraints with allotted resources.
* Ensures systems & processes are validated in a compliant manner in accordance with FDA, EU & NN requirements.
* Ensures commissioning activities during projects reduce changes to systems/processes after being placed under formal change control.
* Leads cross functional teams to ensure all support systems (procedures, calibration, maintenance work orders, etc.) are in place for systems associated with projects.
* Leads the closure of investigations per approved timeframes.
* Requires no guidance & direction to complete these goals & needs no coaching on technical competencies for goal attainment. Serves as a source of expertise in the group for investigations.
* Leads cross functional teams to determine the root cause & corrective actions for problems associated with investigations.
* Regulatory Audits: Project documentation is successfully reviewed during audits without compliance issues.
* Completes accurate & timely assessments associated with change control activities.
* Ensures change control activities for systems are completed in a manner in compliance with FDA, EU & NN regulations.
* Leads change control efforts for process improvements & identifies opportunities for improvements.
* Leads cross functional teams during change control efforts & serves as a source of expertise.
* Maintains Safe Work Environment.
Education: BA/BS in Engineering, Computer Science, or applicable technical degree Mandatory. MA/MS preferred.
* Min. 5 years of project management experience within IT &/or Automation from GxP Production (Pharmaceutical).
* Training or experience with LEAN, change management, QA, (GMP, CSV/GAMP training).
Knowledgeable in the following areas:
* Expert in root cause analysis techniques & cGMP documentation practices.
* Expert understanding of change control processes.
* Hands-on experience preparing protocols, executing data analysis, & report writing.
* Expert understanding of validation/system development life cycle approach.
* Basic computer skills including experience in the use of Microsoft word, Excel, etc.
* Excellent technical writing & oral communication skills.
* Expert knowledge of statistical methods.
* Expert in cGMP regulations.
* Expert knowledge in being a project team leader.
* Excellent negotiation & conflict resolutions skills.
* Excellent presentation & facilitation skills.
* Ability to interact with all levels of the organization.
* Able to operate with a high level of autonomy & authority.
* Capable of establishing & communicating high standards & expectations for performance & holding team members accountable for results.
* Strong analytical/reasoning, organizational & multi-tasking skills.
Organization/Planning: Demonstrated expertise in planning/organizing, managing execution, checking results, & revising the work plan for complex problems being resolved by cross functional teams.
* Ability to lift up to 40 lbs. with assistance.
* Ability to work in confined spaces & near operating equipment.
* Ability to work in loud noisy environments with hearing protection.
* Ability to work hours necessary to support production & /or maintenance activities.
Department IT Major Projects
Position Location US - Clayton, NC
State/Provinces US - NC
At Novo Nordisk, we know that driving change on a global level and improving treatment outcomes for people with diabetes and other chronic diseases begins here at home. That's why we make an unmatched commitment to our employees, our families and our communities. That means outstanding rewards, industry-leading training programs, and an environment that supports you to achieve your goals at every level. It's all part of the Novo Nordisk Way. It includes our Vision and our commitment to the Triple Bottom Line principle – helping us find the right balance between compassion and competitiveness
With a career at Novo Nordisk, you’ll feel a difference right from the start. It’s a sense of inspiration and mobility that comes from a shared belief in driving positive change for people, families, and communities everywhere. Congratulations on taking your first step!
Novo Nordisk is committed to equal employment opportunity and providing reasonable accommodations to applicants with physical and/or mental disabilities. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, gender, sex, age, religion, creed, national origin, ancestry, citizenship, marital status, physical or mental disability, medical condition, veteran status, genetic information, or any other characteristic protected by federal, state, or local law.
Please visit our website at www.novonordisk.com