Posted to MedZilla HealthCare on 1/13/2018


Novo Nordisk

US-NC, Project Manager 2 - IT & Automation Job 450226100A0-MZ


 
 

Requisition ID 53132BR
Title Project Manager 2 - IT & Automation
Job Category Manufacturing
Job Description This is 1 of 2 similar positions.

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:
* Refine business case with project owner/sponsor;
* Establish & communicate quantifiable project benefits;
* Refine & clarify project scope through early project analysis with subject matter experts & owners to further substantiate project purpose
* Provide clear goals so that the project secures effective use of time & resources & builds employee motivation;
* Develop time/resource estimates to complete projects;
* Develop bid packages, bid evaluation, & drive vendor selection. Also work with procurement to create project specific contracts;
* Responsible for financial project accountability through purchase order creation, management, invoicing, & cost forecasting
* Monitor, & control project work with stringent follow-up on quality, schedule & budget so that the project delivers the desired end-product;
* Manage, coordinate, & direct contract resources; Coordinate & direct internal resources;
* Ensure that the right amount of resources & competences is allocated to the project, negotiate project resources with Line of Business (LoB) management;
* Report project performance to the relevant stakeholders;
* Manage strategy development & implementation of change control, qualification, & validation for the project;
* Archive all key project & test documentation in compliance with good documentation practices;
* Ensure alignment with Global programs & other site projects to actively share best practice, knowledge, & visions.

Accountabilities:
Projects:
* 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.

Investigations:
* 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.

Change Control:
* 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.

Experience: Mandatory
Min. 5 years of project management experience from GxP Production (Pharmaceutical or Nuclear or Military), with emphasis on within IT &/or Manufacturing Automation.

Technical/Process/Functional Knowledge:
* Excellent technical writing & oral communication skills.
* Excellent presentation & facilitation skills.
* Expert knowledge in being a project team leader with excellent negotiation & conflict resolutions skills. Capable of establishing & communicating high standards & expectations for performance & holding team members accountable for results.
* Ability to interact with all levels of the organization.
* Able to operate with a high level of autonomy & authority.
* Strong analytical/reasoning, organizational & multi-tasking skills.
* High level understanding of infrastructure services & manufacturing automation systems.
* Expert in cGMP documentation practice & understanding of change control processes.
* Expert understanding of validation/system development life cycle approach.
* Basic computer skills including experience in the use of Microsoft word, power point, excel, etc.

Organization/Planning:
Demonstrated expertise in planning/organizing, managing execution, checking results, & revising the work plan for complex problems being resolved by cross functional teams.

Physical & Other Requirements:
* 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 a 24/7 production operations & /or maintenance activities.

EEO Statement:
Novo Nordisk is an Equal Opportunity Employer - M/F/Veteran/Disability/Sexual Orientation/Gender Identity.

Novo Nordisk is not currently hiring individuals for this position who now or in the future would require sponsorship for employment visa status.

Department Product & IT Projects
Position Location US - Clayton, NC
City Clayton
State/Provinces US - NC
Job/Position Country US

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.

Novo Nordisk will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

If you are interested in applying for employment with Novo Nordisk and need special assistance or an accommodation to use our website or to apply for a position, please call the U.S. Toll Free number at 1-855-411-5290 or click on the following link to submit your request: https://www.surveymonkey.com/r/novoaccommodation. Please note we do not accept applications for employment or employment related solicitations through this site. If you are requesting special assistance, please specify your request by selecting "Yes" in Question 2 on the site. We will not be able to respond to requests unless you specify the need for special assistance or an accommodation in Question 2. Determinations on requests for reasonable accommodation are made on a case-by-case basis.


Please visit our website at www.novonordisk.com

 
 


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