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Biotech Process Development Jobs in Raleigh, NC (NOW HIRING)

Amgen

Sr Engineer I

Holly Springs, NC · On-site

$90K - $124K/yr

The Sr. Engineer will be part of the Process Development-Drug Substance Technology at Amgen's FleX ... biotechnology processes within regulated environments (i.e., cGMP) * In-depth expertise in ...

DivIHN

Process Engineer Pharmaceuticals I

NC · On-site

Support process development and experimental studies, including process characterization and ... Biotechnology, Chemistry/Biochemistry, Chemical/Biochemical Engineering, or equivalent) * Minimum 2 ...

Astrix Inc

Manufacturing Associate

Holly Springs, NC · On-site

As a guiding force in the biotech industry, they set the bar for innovation and advancement. We are ... Collaborate with cross-functional teams (Engineering, Process Development, and Quality Assurance ...

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All JobsBiotech Process Development JobsBiotech Process Development Jobs in Raleigh, NC

Biotech Process Development information

See Raleigh, NC salary details

$18

$32

$48

How much do biotech process development jobs pay per hour?

As of Jun 18, 2026, the average hourly pay for biotech process development in Raleigh, NC is $32.74, according to ZipRecruiter salary data. Most workers in this role earn between $26.88 and $40.19 per hour, depending on experience, location, and employer.

What is biotech process development?

Biotech process development refers to the design, optimization, and scale-up of manufacturing processes used to produce biological products, such as pharmaceuticals, enzymes, or vaccines. Professionals in this field work to turn laboratory procedures into efficient, large-scale industrial processes that meet regulatory and quality standards. This often involves selecting suitable equipment, optimizing conditions, ensuring reproducibility, and troubleshooting production issues. The ultimate goal is to produce high-quality products safely, consistently, and cost-effectively.

What is the difference between Biotech Process Development vs Biotech Manufacturing Associate?

AspectBiotech Process DevelopmentBiotech Manufacturing Associate
Primary FocusDesigning, optimizing, and scaling up bioprocesses for product developmentExecuting manufacturing processes to produce biopharmaceuticals at scale
Work EnvironmentLaboratories and pilot plant facilitiesProduction floors and manufacturing plants
Required SkillsProcess design, lab techniques, troubleshootingEquipment operation, quality control, adherence to SOPs
Typical CredentialsBSc/MSc in Biotechnology, Chemical Engineering, or related fieldsBSc in Biotechnology, Biology, or related fields

While both roles are essential in biotech, Biotech Process Development focuses on creating and optimizing processes during product development, whereas Biotech Manufacturing Associates handle the day-to-day production to ensure consistent product quality at scale.

What are the key skills and qualifications needed to thrive in Biotech Process Development, and why are they important?

To excel in Biotech Process Development, you need a strong background in bioprocess engineering, molecular biology, and chemistry, typically supported by a degree in biotechnology or related fields. Familiarity with tools such as bioreactors, chromatography systems, and data analysis software, along with certifications in Good Manufacturing Practice (GMP), is highly valuable. Strong problem-solving skills, attention to detail, and effective teamwork distinguish top performers in this role. These competencies are crucial for optimizing processes, ensuring product quality, and driving innovation in the biotech industry.

What are some common challenges faced by professionals in Biotech Process Development, and how are they typically addressed?

Professionals in Biotech Process Development often encounter challenges related to scaling up processes from the laboratory to commercial production, ensuring product consistency, and meeting strict regulatory standards. Addressing these challenges typically involves close collaboration with cross-functional teams such as quality assurance, regulatory affairs, and manufacturing. Continuous process optimization, thorough documentation, and robust validation protocols are essential strategies to overcome these hurdles and ensure successful product development and commercialization.
What are popular job titles related to Biotech Process Development jobs in Raleigh, NC? For Biotech Process Development jobs in Raleigh, NC, the most frequently searched job titles are:
What job categories do people searching Biotech Process Development jobs in Raleigh, NC look for? The top searched job categories for Biotech Process Development jobs in Raleigh, NC are:
Biotech Process Development jobs near you
Process Engineer, Biotech Process Equipment Owner - (JP14141)

Process Engineer, Biotech Process Equipment Owner - (JP14141)

3 Key Consulting

Holly Springs, NC

$32 - $38/hr

Other

Posted 18 days ago

Job description

Job Title: Process Engineer, Biotech Process Equipment Owner - (JP14141)
Location: Holly Spring, NC. 43054
Employment Type: Contract
Business Unit:ANC Engineering & Automation
Duration:3 years with likely extensions and/or conversion to permanent
Number of openings: 3
Posting Date:06/04/2025
Pay Rate:$32 - $38/hour
Notes: Standard business hours (~8 to 5) with flexibility for: Evening or weekend work, Occasional holiday support, Up to ~50 hours/week, assuming occasional OT
3 Key Consulting is hiring Process Engineersfor a consulting engagement with our direct client, a leading global biopharmaceutical company.
Ideal candidate is a commercially experienced Process Engineer with a BS in Chemical, Mechanical, or Biomedical Engineering, who has supported large-scale drug substance operations in biotech or pharma. They are hands-on with equipment ownership (not maintenance) and are highly adaptable, collaborative, and proactive. The ideal candidate embraces ambiguity, is passionate about solving complex operational problems, and thrives in a startup-like GMP environment where they can wear multiple hats, support dynamic business needs, and help drive continuous improvement initiatives. Recruiters expected to pre-screen thoroughly and look for tangible examples of initiative and project ownership. Ideal resumes will show practical accomplishments and clearly demonstrate team-based, cross-functional efforts
Not a maintenance role:
They design/own the equipment and support proper maintenance planning, not execution.
This opportunity is based at a brand-new, advanced biologics manufacturing plant. The site features a cutting-edge FleX Batch facility that combines the latest in disposable technologies with traditional stainless-steel systems, enabling maximum operational flexibility. The facility integrates best-in-class manufacturing processes and industry 4.0 capabilities, along with sustainability initiatives designed to reduce carbon emissions and waste.
Top Must Have Skills:
  • Experience working in commercial biotech manufacturing industry.
  • Strong drive and proven results in solving complex and ambiguous problems.
  • Demonstrated ability to work well in highly collaborative environments.

Responsibilities:
In this role, the Engineer will report to the Senior Manager of the Process Engineering group and will provide daily engineering support to the site. Responsibilities include:
  • Serve as system owner for process equipment and systems supporting manufacturing operations.
  • Provide engineering support for design, construction, startup, commissioning, and qualification of new or modified systems.
  • Identify and/or lead implementation of small-to-medium scale equipment or facility improvements, including development of business cases.
  • Develop maintenance programs, ensure spare part availability, and coordinate execution to maintain system reliability.
  • Ensure systems operate safely and in compliance with EHS standards and regulations.
  • Support commissioning and qualification activities in alignment with GMP requirements and regulatory inspections.
  • Apply engineering principles in daily operations, maintenance, and troubleshooting of plant systems.
  • Monitor system performance and implement risk-reduction strategies.
  • Lead or support troubleshooting efforts to minimize production downtime, including root cause analysis and CAPA implementation.
  • Support new product and technology introductions via engineering assessments, equipment modifications, and pilot runs.
  • Advance use of predictive maintenance and condition-based monitoring using data analytics where applicable.
  • Lead or contribute to deviation investigations and other quality-related processes.
  • Analyze and present findings related to operational issues and engineering projects.
  • Provide technical support to commercial and clinical manufacturing, specifically in process control and equipment.
  • Collaborate with cross-functional groups such as manufacturing, process development, utilities, maintenance, quality, and validation to drive operational improvements.
  • Maintain regular communication with leadership and team members, escalating issues with proposed solutions.
  • Participate in a small engineering team on a project or ongoing support basis.
  • Provide rotational on-call support for utility systems, including nights, weekends, and holidays as needed.
  • Participate in the design and selection of systems, instrumentation, and components.
  • Evaluate supplier capabilities and assess new technologies to improve cost, throughput, or technical capabilities.
Preferred Qualifications:
  • Bachelor's degree in Chemical or Mechanical Engineering.
  • 3+ years of relevant work experience, including 2+ years in a biopharmaceutical manufacturing environment.
  • Hands-on experience with GMP production equipment such as bioreactors, centrifuges, filtration systems, and purification technologies.
  • Proficiency with equipment and facility control systems, including troubleshooting and logic understanding.
  • Experience in regulated environments (e.g., cGMP, OSHA, EPA) and knowledge of quality systems (e.g., change control, non-conformances, CAPA, validation).
  • Strong communication, technical writing, and presentation skills; ability to work independently.
  • Proven team collaboration and facilitation skills.
  • Analytical thinking with the ability to interpret complex problems using multiple data sources.
  • Ability to support capital projects and implement process improvements.
  • Understanding of capital project execution from procurement through validation in GMP environments.
  • Commitment to safety and compliance in all engineering activities.
  • Self-starter with excellent organization, time management, and multitasking skills.
  • Willingness to work flexible hours in support of 24/7 manufacturing operations.

Why is the Position Open?
Additional team member
Red Flags:
  • Gaps in employment without clear justification
  • Not a maintenance role: They design/own the equipment and support proper maintenance planning, not execution.
  • Not a research role. Candidates with advanced degrees seeking research roles should not be submitted.
  • Lack of biotech experience.
  • Lack of desired degree (Chemical, Mechanical, or Biomedical Engineering).
  • Rigid personalities or candidates uncomfortable with ambiguity or startup-like agility

Interview process:
Manager Phone Screening followed by interview panels and post panels follow-up meeting with hiring manager.
We invite qualified candidates to sendyour resume toresumes@3keyconsulting.com. Ifyou decide that you're not interested in pursuing this particular position, please feel free to take a look at the other positions on our websitewww.3keyconsulting.com/careers. You are also welcome to sharethis opportunity withanyone you think might be interested in applying for this role.

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