Novan
  • 16-Apr-2018 to 19-Jun-2018 (CST)
  • Morrisville, NC, USA
  • Full Time

Purpose:

The Production Technician is responsible for the safe manufacture of active pharmaceutical ingredients (APIs) and drug products in a Good Manufacturing Process (GMP) environment.  This position will operate and maintain manufacturing equipment and instrumentation necessary to support GMP production processes following production batch records.  Additionally, this position will assist in deviation and other GMP documentation.  The Production Technician shall adhere to the Company's quality system including but not limited to the applicable standards, policies and procedures in the areas of responsibility defined in this job description.

 

Responsibilities:

  1. Execute API/Drug Product manufacturing operations in the Company's cGMP facility, including:
    • Request and dispense raw materials for manufacture
    • Operate process reactors, filters, dryers, tubes, pump fillers and formulation equipment
    • Operate jet milling equipment
    • Sample product for release testing
    • Clean and maintain reactors, filters, and jet milling equipment
    • Maintain a safe working environment
    • Observe and follow all safe operation practices
    • Routinely inspect facility safety equipment
    • Maintain a clean and organized production environment
    • Waste treatment and transfer for disposal
  1. Operate and maintain equipment and instrumentation necessary to support cGMP manufacture of APIs as described in production batch records including:
    • Conduct preventative maintenance activities, where appropriate
    • Assist in maintaining equipment records pertaining to preventive maintenance and calibration activities, and equipment warranties
    • Assist in deviation investigations and all other forms of GMP documentation
    • Suggest improvements to operations in GMP facility
    • Document production activities per SOPs and cGMPs
    • Monitor the environment of the GMP facility by following SOPs for airborne particles, room differential pressures, and sanitation.
    • Maintain inventory of consumables and supplies required for GMP production.
  1. Complete proper documentation for batch records, cleaning protocols, equipment use logs, and equipment status tags and labeling.
  2. Coordinate the cleaning, qualification, calibration, and preventive maintenance of equipment and instrumentation.
  3. Participate in staff meetings and special project teams where required.
  4. Perform duties on site, on time, and within the Company's normal business hours listed in the Employee Handbook. Perform other duties as assigned.

 

Qualifications:

Education

  • Associates or Bachelor's degree or equivalent (degree in sciences strongly preferred).

 

Experience:

  • 5 to 10 years of experience working in a pharmaceutical API/Drug Product production facility.
  • Direct experience with cleaning, maintaining and controlling qualified equipment and instrumentation in a GMP environment.
  • Prior deviation, investigation, and SOP writing experience including ability to perform IQOQs.

 

Skills:

  • Strong verbal and written communication skills with an ability to work in cross-functional product development and manufacturing teams.
  • Honest, flexible, dependable, self-motivated team player with the demonstrated ability to work independently. Willingness to accept responsibility and work assignments.
  • Knowledge of pharmaceutical industry practices, regulations and requirements required.
  • Ability to conduct a wide range of GMP manufacturing efforts; familiarity with R&D manufacturing requirements
  • Ability to prioritize workload and manage time to complete multiple projects within established timelines and goals with minimal supervision in a fast-paced environment.
  • Proficient in MS Office software.  

 

Physical Demands and Work Environment:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

 

As part of the regular duties for this job, a candidate must:

  • Be able to wear respiratory protection.
  • Be able to work with various chemicals once given proper protective equipment.
  • Have sufficient dexterity to don and doff clean room clothing over normal work attire.
  • Be able to lift 50 pounds of weight repeatedly and safely.
  • Be capable of operating a computer and sitting for extended periods.

 

In the typical office environment requirements include:  reading, speaking, hearing, close vision, walking, bending, sitting, use hands and fingers (i.e. typing).  There will be requirements to work outside of normal business hours. 

 

Novan, Inc. maintains a drug-free workplace and performs pre-employment and employment substance abuse testing and background verification checks.

 

Novan, Inc. is an equal opportunity employer and does not discriminate against any employee or applicant for employment.  We encourage and foster diversity in the workplace.

Novan
  • Apply Now

  • * Fields Are Required

    What is your full name?

    How can we contact you?

    By clicking the button above, I agree to ApplicantPro's Applicant Information Use Policy.
  • Sign Up For Job Alerts!

.
Logo Home Company Technology Product Pipeline Investors & Media