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Biotech Process Engineer Jobs in North Carolina (NOW HIRING)

Biomerics

Molding Process Engineer

Winston Salem, NC · On-site

... device and biotech industries. As a vertically integrated company, we specialize in designing ... Essential Functions Creation and documentation of a consistent molding process for new molds needed ...

Biogen

NC · On-site

$107K - $143K/yr

About This Role As a Senior Process Engineer , you will be a key technical authority and Subject ... As a mid-sized biotechnology company, we provide the stability and resources of a well-established ...

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Biotech Process Engineer information

See North Carolina salary details

$45K

$83.6K

$129.5K

How much do biotech process engineer jobs pay per year?

As of Aug 22, 2026, the average yearly pay for biotech process engineer in North Carolina is $83,626.00, according to ZipRecruiter salary data. Most workers in this role earn between $67,700.00 and $93,600.00 per year, depending on experience, location, and employer.

What does a Biotech Process Engineer do?

A Biotech Process Engineer designs, develops, and optimizes processes used in the production of biological products such as pharmaceuticals, vaccines, and biofuels. They work closely with scientists and manufacturing teams to scale up lab procedures to industrial levels while ensuring product quality and regulatory compliance. Their role often involves troubleshooting equipment, improving efficiency, and implementing new technologies within biotech manufacturing environments.

What are the key skills and qualifications needed to thrive as a Biotech Process Engineer, and why are they important?

To thrive as a Biotech Process Engineer, you need a solid background in chemical or biochemical engineering, process design, and regulatory compliance, typically supported by a relevant bachelor's or master's degree. Familiarity with process control systems, bioprocess simulation software, and industry-standard quality systems such as cGMP is essential. Strong analytical thinking, problem-solving abilities, and effective teamwork and communication skills help you excel in cross-functional environments. These skills ensure efficient, compliant, and innovative bioprocess operations, which are critical for product quality and organizational success.

What are some common challenges faced by Biotech Process Engineers during scale-up from laboratory to production?

Biotech Process Engineers often encounter challenges when scaling up processes from laboratory or pilot scale to full production. These challenges can include maintaining product consistency, ensuring process sterility, and adapting equipment to handle larger volumes without compromising yield or quality. Engineers must also collaborate closely with cross-functional teams such as quality assurance, validation, and manufacturing to implement changes efficiently and adhere to regulatory standards. Proactive problem-solving and strong communication skills are key to overcoming these hurdles and ensuring successful technology transfer.

What is the difference between Biotech Process Engineer vs Biotech Manufacturing Technician?

AspectBiotech Process EngineerBiotech Manufacturing Technician
CredentialsBachelor's degree in biotech, chemical engineering, or related field; often requires experience in process designAssociate's or bachelor's degree; focus on operational skills and equipment handling
Work EnvironmentDesigning, optimizing, and overseeing production processes in labs or manufacturing facilitiesOperating and maintaining equipment on the manufacturing floor
Job FocusProcess development, scale-up, troubleshooting, and process improvementExecuting production tasks, quality checks, and equipment setup

Biotech Process Engineers focus on designing and improving manufacturing processes, requiring technical and analytical skills. In contrast, Biotech Manufacturing Technicians handle day-to-day production operations. Both roles are essential in biotech manufacturing but differ in responsibilities and required qualifications.

What are popular job titles related to Biotech Process Engineer jobs in North Carolina?

For Biotech Process Engineer jobs in North Carolina, the most frequently searched job titles are:

What job categories do people searching Biotech Process Engineer jobs in North Carolina look for?

The top searched job categories for Biotech Process Engineer jobs in North Carolina are:

Biotech Process Engineer jobs near you
Infographic showing various Biotech Process Engineer job openings in North Carolina as of August 2026, with employment types broken down into 69% Full Time, and 31% Contract. Highlights an 94% In-person, and 6% Hybrid job distribution, with an average salary of $83,626 per year, or $40.2 per hour.

KBI: US - Process Engineer III

KBI Biopharma, Inc.

Durham, NC • On-site

Full-time

Re-posted 21 days ago

KBI Biopharma rating

6.5

Company rating: 6.5 out of 10

Based on 6 frontline employees who took The Breakroom Quiz

Job description

Job Description
Process Engineering is responsible for all Manufacturing process equipment and ensures the equipment and site infrastructure is in an active state to support cGMP operations.
As a Process Engineer, you will act as member of a cross-functional team to support implementation of new systems and improvements to existing manufacturing processes and equipment. You will apply sound scientific and engineering principles to successfully define upstream and downstream process equipment requirements, specifications and standards for facility fit, and assess equipment design and operation in a commercial cGMP production facility. This may include upstream activities such as cell culture and harvest, and/or downstream processes such as chromatography, purification, and filtration. You will be at the forefront of existing best practices and evaluating technologies. Provide system ownership for Biopharmaceutical process equipment. Identify, support, and/or lead implementation of engineering-based improvements or upgrades to the equipment or facility systems. This may include development of business case for improvement and identification of design requirements and then translation of requirements into process equipment/system design, specification and supporting the construction, startup, and validation of process equipment.
Key Responsibilities
  • You will support equipment commissioning and qualification activities related to new or modified processes.
  • Collaborate with MS&T and Manufacturing teams to troubleshoot and resolve equipment and process-related issues in manufacturing systems.
  • Act the technical subject matter expert (SME) for upstream and/or downstream equipment and the site clean utilities ensuring proper installation, qualification, and maintenance of these systems.
  • Lead process engineering related projects to improve manufacturing operations or implementation of new processing equipment. As the project lead you will ensure on time delivery, compliance with project requirements, and project budget.
  • Lead the development, scale-up, and optimization of upstream (cell culture, fermentation) and/or downstream (purification, filtration) processes for biologics or advanced therapies
  • Design and execute experiments to improve process robustness, yield, and product quality
  • Collaborate with Engineering, Quality, Regulatory, and Manufacturing teams to ensure seamless tech transfer and GMP compliance
  • Author and review process documentation including SOPs, and Engineering Studies protocols
  • Serve as a technical lead in cross-functional project teams and represent process engineering in regulatory filings and audits
  • Evaluate and implement new technologies (e.g., single-use systems, PAT tools, continuous processing) to enhance scalability and efficiency
  • Support capital projects including facility design, equipment selection, and commissioning
  • Lead risk assessments, and root cause investigations for process deviations
  • Communicate with other KBI sites for problem solving and consistency of processes through the organization.
  • Contribute to developing a culture of continuous improvements on processes and tools in close collaboration with other.
  • You will perform facility fit activities for various production scenarios.
  • You should be able to apply engineering principles in-order to problem-solve and drive projects to successful completion within defined timelines.
  • The ability to manage multiple concurrent projects and resources.
  • Lead and support CAPA, Change Control, Deviation, Risk Analysis, Root Cause Analysis, and other Quality Systems.
  • Providing technical support for equipment modifications, deviations, change controls, and CAPAs.
  • Develop and maintain equipment SOPs (Standard Operating Procedures), training, and other process documentation.

Qualifications:
• Bachelor's in chemical engineering, Biochemical Engineering, or related field
• 5+ years of experience in bioprocess development or manufacturing within the biotech or biopharma industry
• Expertise in biologics, cell therapy, gene therapy, drug substance production processes
• Strong understanding of cGMP regulations, FDA/EMA guidelines, and validation principles
• Proficiency in process modeling and simulation tools
• Demonstrated leadership in cross-functional teams and project management
• Excellent communication, analytical, and problem-solving skills
• Experience with regulatory submissions (IND, BLA, MAA) is a plus
KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.
I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary.
I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.

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