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Biotech Process Engineer Jobs in Colorado (NOW HIRING)

Turner Construction

Engineer

Denver, CO · On-site

Previous Biotech/pharma experience is strongly preferred. *** Position Description: Manage ... Overseeing the close-out process. Preparing final records for the project such as Requests for ...

Turner Construction

Engineer

Denver, CO · On-site

Previous Biotech/pharma experience is strongly preferred. *** Position Description: Manage ... Overseeing the close-out process. Preparing final records for the project such as Requests for ...

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$52K

$96.8K

$149.8K

How much do biotech process engineer jobs pay per year?

As of May 28, 2026, the average yearly pay for biotech process engineer in Colorado is $96,758.00, according to ZipRecruiter salary data. Most workers in this role earn between $78,300.00 and $108,300.00 per year, depending on experience, location, and employer.

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 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 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 Colorado? For Biotech Process Engineer jobs in Colorado, the most frequently searched job titles are:
What job categories do people searching Biotech Process Engineer jobs in Colorado look for? The top searched job categories for Biotech Process Engineer jobs in Colorado are:
Biotech Process Engineer jobs near you
Senior Process Engineer, Drug Product Development

Senior Process Engineer, Drug Product Development

Umoja Biopharma

Louisville, CO

$108.70K - $140.60K/yr

Full-time

Medical, Dental, Vision, Retirement, PTO

Posted 16 days ago

Job description

Umoja Biopharma is an industry-leading biotech with locations in Seattle, WA and Louisville, CO, focused on transforming the treatment of cancer with a novel integrated immunotherapy platform. Our vision is to develop off-the-shelf therapies capable of treating any tumor, any time. We are a diverse and growing team working in brand-new facilities in downtown Seattle, Washington and Louisville, Colorado, and we are looking for innovative thinkers who are excited by groundbreaking science and technology, and passionate about squaring up to the challenges inherent to cutting-edge drug development. We are committed to our core values and principles that support our overall mission and strongly invite applications from enthusiastic individuals who share our commitment and help position Umoja to deliver on our goals. We at Umoja believe in the importance of stories; we are looking for great people to join our team to help us create more stories for ourselves, for you, and most importantly for patients and their families.

Umoja Biopharma – Your Body. Your Hope. Your Cure.

POSITION SUMMARY

Umoja is seeking a Senior Process Engineer to join the Drug Product Development group within our Process Sciences team. This role will lead the development, scale-up, and tech transfer of lentiviral vector drug product and drug substance processes from lab to GMP scale (250 mL to 200 L), applying Quality by Design (QbD) principles, and supporting transitions through multiple clinical stages. A successful candidate will have a thorough understanding of fill-finish strategies and experience with internal and external tech transfer activities.

This is a fully onsite role based out of our Louisville, CO location.

CORE ACCOUNTABILITIES

Specific responsibilities include:

  • Serve as technical lead for process development and tech transfer activities for lentiviral vector drug substance and drug product fill processes.
  • Represent Process Sciences on CMC program teams, contributing to the process strategy, risk identification and assessment, and project management for Ph1 and beyond.
  • Operate, troubleshoot, and improve lab and production scale processes, consumables, and equipment for drug substance filtration and drug product fill-finish.
  • Evaluate and implement new equipment and process analytical technology (PAT) solutions.
  • Design and execute experiments to support program teams, process characterization, control strategy, and process performance qualification (PPQ).
  • Analyze, interpret, and effectively present data and findings to diverse audiences, including technical peers, external partners, and strategic audiences. This will include experimental, correlative, as well as, continuous process monitoring/trending data.
  • Implement and improve data workflows using tools like Benchling, JMP, and Ganymede.
  • Collaborate closely with the Process Sciences team (upstream, downstream, and optimization), analytical development, manufacturing, supply chain, non-clinical, clinical, research teams, and contract manufacturers.
  • Author technical documentation including SOPs, process descriptions, batch records, IND sections, development reports, and requirement specifications (MRS/URS).
  • Provide person-in-plant (PIP) support during GMP campaigns, mentor junior staff, and be a qualified trainer for Drug Substance and Drug Product processes.
  • Support new product introduction (NPI) activities.
  • Other duties as assigned.

The successful candidate will have:

  • BS/MS in chemical engineering, biochemistry, virology, or related field with a minimum of 5/3 years of relevant experience respectively.
  • Expertise in TFF, NFF, and process analytical technologies, including hands-on experience with the following systems, Repligen, AMBR Crossflow, and sterile filtration operation. Experience with novel filtration methods is desired.
  • Experience with experimental design, planning, execution, and complex data organization and analysis. Specific experience working with Benchling, JMP, Ganymede, INVERT, Python, Smartsheet, and data historians is a plus.
  • Experience with early and late phase implementation of process improvements.
  • Experience with early-phase clinical development and commercial readiness.
  • Experience with QbD, process risk assessments, and process characterization.
  • Proficiency in tech transfer, GMP operations, process description and batch record authoring, GDP, change control, and ALCOA+ principles.
  • Strong communication, collaboration, and technical writing skills.
  • Ability to balance multiple priorities in a fast-paced, cross-functional, and dynamic environment and perform tasks across a variety of programs.

Preferred Qualifications:

  • Working knowledge of lentiviral vector processes, from upstream cell culture through drug substance and drug product storage and filling processes (e.g. Bioreactors, Repligen TFF systems, Pendotech NFF systems, membrane and monolith chromatography) is strongly preferred.
  • Working knowledge of lentiviral vector analytical methods (e.g., flow cytometry, PCR, ELISA, HPLC).
  • Experience managing fill-finish CDMOs.
  • Experience with fill-finish capital projects.
  • Experience identifying and implementing creative and novel strategies to viral vector purification processes.
  • Experience with Aseptic Process Simulations and Hazard Identification Tools risk tools.
  • Familiarity with designing closed-process purifications.

Physical Requirements:

  • Ability to work onsite 5 days/week at our Louisville, CO location.
  • 100% compliance with personal protective equipment (PPE) requirements in laboratory environments for wet lab work, including gloves, protective clothing, and eye safety glasses.
  • Perform physical tasks required for the role, including standing, walking, bending, kneeling, sitting, working your hands in a biosafety cabinet, and occasionally moving materials up to 50 pounds.
  • Ability to work weekends, evenings, and holidays as needed.
  • Ability to travel on occasion.

Salary Range: $108,400 - $133,900

Benefits Offerings

Umoja Biopharma offers its employees competitive Medical, Dental, and Vision plans. Additionally, we offer Umojians access to a 401k plan through Fidelity, with a 100% match up to their first 4% deferral. Umoja also provides a generous Paid Time Off policy, employee commuter benefits, and cell phone stipend. For a full breakdown of our benefits offerings, please see the Benefits section of our website.