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IT Validation Area Specialist

Facility:  Information Technology & Telecom
Location: 

Clayton, NC, US

About the Department   

At Novo Nordisk, we want to make a difference. For nearly 100 years, we have led the way in diabetes care. 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 Clayton, NC, we now operate two adjacent pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable and oral treatment supply chains.  
 
Our Clayton, NC Diabetes Finished Products (DFP) facility is a 457,000 square foot aseptic "fill and finish" site that is responsible for producing innovative, injectable diabetes and obesity treatments. When you work at DFP, you’ll join a global network of manufacturing professionals focused on several key, final production processes, including sterile formulation, filling, inspection, device assembly and packaging. 
 
At DFP, our employees are passionate about what they do, knowing their work makes a difference to millions of people who rely on our products every day. After all, producing medicines is a special responsibility. 
 
Join Team Novo Nordisk and help us make what matters.

 

Position Purpose

Primary responsibility is to provide/lead validation services required for the successful delivery of the IT & Automation Projects, including:

  • 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
  • Create new & modify existing validation procedures as required
  • Lead validation failure investigations & non-conformities utilizing root cause analysis techniques
  • Create & modify existing configuration item lists (CIL’s) as required
  • Review & approve 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, system or process
  • Identify process improvements before equipment, systems or processes are placed under change control during validation
  • Budget oversight as needed.

 

Contractor scheduling & oversight as needed.

 

Accountabilities

  • New Systems Validations
    • 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.
  • Revalidations
    • Execute & complete assigned revalidations 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 revalidations
    • Ensure revalidation protocols executed are in compliance with local, corporate & regulatory regulations.
  • 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 obtainment
    • Leads project teams to help identify root causes of failures & implement corrective actions which address & eliminate potential reoccurrence of the failures.
  • Protocol Review & Approval
    • Complete assigned protocol review & approvals per approved timeframes accurately & completely
    • Ensure protocols & protocol data reviewed are in compliance with local, corporate & regulatory regulations.
  • Validation Procedures & Configuration Item List (CIL)
    • Create & author assigned validation procedures & CILs. Requires no guidance & direction to complete these goals & needs no coaching on technical competencies for goal obtainment
    • Ensure validation procedures & CILs are in compliance with local, corporate & regulatory regulations.
  • Other Procedures/Documents – Specifications, Process Descriptions, etc.
    • Complete reviews & approvals as assigned per approved timeframes accurately & completely
    • Ensure procedures /documents reviewed are in compliance with local, corporate & regulatory regulations
    • Approver of protocols, specifications, deviations, equipment manuals, configuration item list as authorized by the Quality Engineering manager. Approver of SOPs & CR2 documentation as authorized by the Quality Assurance manager.
  • Capital Projects
    • Leads validation activities assigned by overall project manager. 
  • Maintains Safe Work Environment

 

Required Qualifications

BS in Engineering, Computer Science, or applicable technical degree.

 

Required Qualifications

  • Minimum 7 years validation or quality related discipline experience in pharmaceutical environment
  • Minimum of 1 year of project management experience for small to medium sized projects with experience developing project schedules & tracking performance
  • At least 2 years of demonstrated experience using root-cause analysis techniques to solve problems

 

Technical/Process/Functional Knowledge

  • Knowledgeable in the following areas: Expert in quality concepts including technical & compliance review of documents, expert competence in one or more core validation areas (sterilization, packaging, cleaning, utilities, process or computer validation)
  • Expert in cGMP documentation practices
  • Requires a minimum of 2 years of experience in reviewing GMP documents for compliance purposes for approval of quality documentation
  • Basic computer skills including experience in the use of Microsoft word, Excel, etc.
  • Ability to independently write protocols & technical documents without supervision.  Knowledge of statistical methods
  • Expert knowledge of cGMP documentation practices required
  • Excellent oral & written communication skills
  • Experience in regulatory cGMP regulations
  • Experience in validation test equipment including temperature mapping equipment, Kaye equipment as an example, desired
  • Expert knowledge in being a project team participant & team leader
  • Expert in utilizing appropriate root-cause analysis tools & techniques

 

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 Requirements

  • Ability to lift up to 40 lbs. with assistance
  • Ability to work in confined spaces & near operating equipment
  • Ability to be clean room certified
  • Ability to work in loud noise environments
  • Ability to work hours necessary to support production & /or maintenance activities

 

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.