BioProcess Engineer Downstream/Fill-Finish

Band

Level 2

Job Description Summary

This position will be located at Durham NC and will not have the ability to be located remotely.

The BioProcess Engineer downstream/FillFinish is responsible for executing the manufacturing operations at the plant/site. The level of the role will be determined by the years of relevant experience.

#LIOnsite

Key Responsibilities:
This role is a 223 day shift position.
Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.

Performs commercial and clinical manufacturing operations on the site including purification (downstream) fillfinish (drug product visual inspection packaging) media/buffer preparation and any additional supporting activities.
Learns to troubleshoot equipment participates in interviews on deviations partners with other business units to assist in manufacturing led deviations standardizes equipment and cleans production area.
Assists in determining root cause implementing solutions and verifying solutions are effective.
Assists with the creation and ongoing maintenance of all pertinent equipment policies and procedures.
Learn and perform aseptic techniques applicable to cell culture recovery purification aseptic fill/finish (upstream and downstream).
Supports the product requirements to ensure that all products are produced according to plan. Learn cGMP and cGDP and ensure cGMP documentation is being filled out correctly training is current and all quality requirements are being followed.
Maintains quality standards to meet cGMP requirements CFRs and internal company policies directly related to the manufacturing process.
Partners with the Quality department to ensure a compliant manufacturing environment.

Job Description

Desirable Requirements:

• For BioProcess Engineer I Bachelor of Science Degree in Biology Chemistry Biotechnology or applicable field or 2 years equivalent experience;
• For for BioProcess Engineer II Bachelor of Science Degree in Biology Chemistry Biotechnology or applicable field and 2 years experience in cGMP experience in biologics pharmaceutical and/or vaccine manufacturing operations including experience in cell culture recovery purification bulk formulation and/or fill finish environment; OR four (4) years experience in cGMP experience in biologics pharmaceutical and/or vaccine manufacturing operations including experience in cell culture recovery purification bulk formulation and/or fill finish environment in lieu of degree;
• For BioProcess Engineer III Bachelor of Science Degree in Biology Chemistry Biotechnology or applicable field and 4 years experience in cGMP experience in biologics pharmaceutical and/or vaccine manufacturing operations including experience in cell culture recovery purification bulk formulation and/or fill finish environment; OR six (6) years experience in cGMP experience in biologics pharmaceutical and/or vaccine manufacturing operations including experience in cell culture recovery purification bulk formulation and/or fill finish environment in lieu of degree
• Excellent oral and written communication skills
• Entry level into the biopharmaceutical based GMP manufacturing operations no experience necessary.
• Near vision performance should be the equivalent of 20/20 with no impairment of color vision. The use of corrective lenses to achieve the desired visual acuity is permitted.
  
  

Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $66800 and $124000/year; however while salary ranges are effective from 1/1/25 through 12/31/25 fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further final pay determinations will depend on various factors including but not limited to geographical location experience level knowledge skills and abilities. The total compensation package for this position may also include other elements including a signon bonus restricted stock units and discretionary awards in addition to a full range of medical financial and/or other benefits (including 401(k) eligibility and various paid time off benefits such as vacation sick time and parental leave) dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired employee will be in an atwill position and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time including for reasons related to individual performance Company or individual department/team performance and market factors.

Company will not sponsor visas for this position.

Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.

EEO Statement:

The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment hiring training promotion or other employment practices for reasons of race color religion gender national origin age sexual orientation gender identity or expression marital or veteran status disability or any other legally protected status. We strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

Accessibility and reasonable accommodations

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If because of a medical condition or disability you need a reasonable accommodation for any part of the application process or in order to perform the essential functions of a position please send an email to call 1 (877)and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Range

$66800.00 $124000.00

Skills Desired

Assembly Language Cooperation Efficiency Electronic Components Flexibility General Hse Knowledge Good Documentation Practice Installations (Computer Programs) Iso (International Organization For Standardization) Job Description Knowledge Of Gmp Lean Manufacturing Manufacturing Process Manufacturing Production Nuclear Medicine Physics Product Distribution Production Line Scheduler