Posted to MedZilla on 2/17/2018

Novo Nordisk

US-NC, Validation Area Specialist Job 456644500A0-MZ


Requisition ID 54010BR
Title Validation Area Specialist
Job Category Quality
Job Description Position Purpose: Primary responsibility is to provide/lead validation services required for the successful delivery of IT & Automation projects.

* Provide validation & technical support through the preparation, execution, data analysis, & report writing for IQ, OQ & PQ protocols.
* Ownership of Change Requests (CR’s) related to project validation responsibilities.
* Perform compliance & technical reviews/approvals of protocols & protocol data.
* Author & execute assigned IQ, OQ & PQ protocols for direct impact systems/processes per approved timeframes. Requires no guidance & direction to complete these goals & needs no coaching on technical competencies for goal obtainment. Serves as a source of expertise in the group for validating new systems.
* Ensure validation protocols executed are in compliance with local, corporate & regulatory regulations.
* Lead validation failure investigations & non-conformities utilizing root cause analysis techniques.
* Create & modify existing validation procedures & configuration item lists (CIL’s) as required.
* Write/Review specifications, procedures, & other required supporting documents to maintain the validated state of equipment & processes.
* Participate in FAT, SAT commissioning efforts for equipment, automation systems & processes & successfully transition into the ownership role for validation efforts related to the equipment.
* Identify process improvements before equipment, systems or processes are placed under change control during validation.
* Budget oversight as needed.
* Contractor scheduling & oversight as needed
* Leads validation activities assigned by overall project manager.
* Other duties & tasks, as assigned.

* BA/BS degree in Engineering, Computer Science, or applicable technical degree or proven equivalent relevant work experience. Mandatory
* MA/MS/MBS degree preferred.

* Minimum 7 years validation or quality related discipline experience in pharmaceutical environment. Mandatory
* Experienced with regulatory requirements & industry standards for pharmaceutical &/or medical device manufacture, such as 21 CFR Part 11, GAMP5, ISO, electronic records retention, configuration items lists, FDA & ICH guidance documents. Mandatory
* Demonstrated experience using root-cause analysis techniques to solve problems.

Technical/Process/Functional Knowledge:
* Ability to read, write & understand complicated product documentation.
* Demonstrated leadership & project management skills: two-way communication skills with customers (internal/external), project team & management; interpersonal & team building skills; achievement of project timelines & customer requirements.
* Ability to write technical documentation based on equipment manuals.
* Experience in pharmaceutical manufacturing preferred. Knowledgeable in GMP concepts.
* Knowledge of standard operating procedures with attention to high-level concepts.

* Ability to manage multiple tasks/deadlines & prioritize properly based on process needs.
* Demonstrated strong skills in change management within Novo Nordisk.

Physical & Other Requirements:
* Occasionally moves equipment &\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 the project & 24/7 continuous manufacturing operation once in production.
* Able to travel internationally, up to 10% of the time.

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 SEMA SDD FP
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: 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


* If a direct employer requests that you go to their web site and complete your application there in order to be
  considered, please do so. Applications for all positions are subject to each employer's specific requirements.