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Aseptic Process Engineer Jobs in Colorado (NOW HIRING)

Umoja Biopharma

Senior Specialist, Quality Assurance

Louisville, CO · On-site

$86K - $118K/yr

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

This role partners closely with Manufacturing, Process Sciences, Engineering, Facilities, Quality ... Experience supporting viral-vector, cell-therapy, gene-therapy, biologics, or aseptic manufacturing ...

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Aseptic Process Engineer information

See Colorado salary details

$32.7K

$84.1K

$125.7K

How much do aseptic process engineer jobs pay per year?

As of Aug 16, 2026, the average yearly pay for aseptic process engineer in Colorado is $84,145.00, according to ZipRecruiter salary data. Most workers in this role earn between $69,300.00 and $94,900.00 per year, depending on experience, location, and employer.

What is an aseptic process engineer?

Aseptic process engineers are professionals who design, develop, and maintain sterile manufacturing systems, primarily in the pharmaceutical, biotechnology, and food industries. Their main responsibility is to ensure that products are produced in a contamination-free environment, using processes that prevent the introduction of microorganisms. This involves overseeing the design of cleanrooms, validating equipment, developing standard operating procedures, and ensuring regulatory compliance. Aseptic process engineers work closely with quality assurance teams to maintain high standards of product safety and efficacy. Their expertise is crucial for industries where product sterility is critical to consumer safety.

What are the key skills and qualifications needed to thrive as an aseptic process engineer, and why are they important?

Aseptic Process Engineers need a strong background in chemical, mechanical, or biomedical engineering, along with experience in aseptic manufacturing environments and a solid understanding of GMP regulations. Familiarity with process automation systems, sterilization equipment, and industry certifications such as Six Sigma or Lean Manufacturing are often required. Attention to detail, strong problem-solving abilities, and effective communication are vital soft skills for ensuring product quality and process efficiency. These skills are crucial for maintaining sterile conditions, regulatory compliance, and the safe production of pharmaceuticals or biotechnology products.

What are some common challenges faced by aseptic process engineers, and how can they be addressed?

Aseptic Process Engineers often encounter challenges such as maintaining strict sterility standards, troubleshooting equipment issues, and ensuring compliance with changing regulatory requirements. Addressing these challenges requires strong attention to detail, proactive communication with cross-functional teams, and staying current with industry best practices and regulations. Collaborating closely with quality assurance, production, and maintenance teams helps to identify and resolve issues quickly, ensuring that processes remain efficient and compliant.

What is the difference between Aseptic Process Engineer vs Pharmaceutical Manufacturing Technician?

AspectAseptic Process EngineerPharmaceutical Manufacturing Technician
CredentialsBachelor's degree in engineering, life sciences, or related field; GMP trainingHigh school diploma or associate degree; GMP training often required
Work EnvironmentCleanroom, sterile environments, manufacturing facilitiesManufacturing floors, production areas, sometimes cleanrooms
Industry UsageDesign, optimize, and validate aseptic processes in pharmaOperate equipment, assemble products, support manufacturing

The Aseptic Process Engineer focuses on designing and validating sterile manufacturing processes, requiring specialized engineering knowledge. In contrast, the Pharmaceutical Manufacturing Technician handles day-to-day production tasks, often with less formal education but essential for maintaining manufacturing flow. Both roles are vital in pharmaceutical production but differ in responsibilities and qualifications.

What are popular job titles related to Aseptic Process Engineer jobs in Colorado?

For Aseptic Process Engineer jobs in Colorado, the most frequently searched job titles are:

What job categories do people searching Aseptic Process Engineer jobs in Colorado look for?

The top searched job categories for Aseptic Process Engineer jobs in Colorado are:

What cities in Colorado are hiring for Aseptic Process Engineer jobs?

Cities in Colorado with the most Aseptic Process Engineer job openings:

Aseptic Process Engineer jobs near you

Senior Specialist, Quality Assurance

Umoja Biopharma

Boulder, CO

$85K - $117K/yr

Full-time

Posted 7 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 Biopharma is seeking a Senior Specialist, Quality Assurance to provide Quality Assurance oversight and subject matter expertise in support of new product introduction, and routine current Good Manufacturing Practice (cGMP) operations. This role partners closely with Manufacturing, Process Sciences, Engineering, Facilities, Quality Control, Supply Chain, Regulatory Affairs, and other functions to ensure operations are conducted in accordance with approved procedures, internal quality standards, and applicable regulatory requirements. The Senior Specialist, Quality Assurance independently provides quality guidance, reviews and approves GMP documentation, supports investigations and change implementation, provides on-the-floor QA oversight, and contributes to the development and continuous improvement of site quality systems.

CORE ACCOUNTABILITIES
Specific responsibilities include:

  • Independently provides Quality oversight and direction in support of task execution during site start-up and routine cGMP (current Good Manufacturing Practice) operations.
  • Interfaces with other departments (e.g., Supply Chain, MSAT, Facilities, Validation, Manufacturing, and Quality Control) to ensure compliance with all applicable procedures, policies, and standards.
  • Provides strategic quality input and subject matter expertise on implementation of site material controls.
  • Reviews and approves material specifications and performs material disposition.
  • Reviews and approves Master Batch Records, work instructions, SOPs, specifications, and other controlled documents related to operations and other cGMP activities as needed
  • Reviews and approves SOPs, work instructions, product specifications, and other controlled documents related to operations and other cGMP activities as needed.
  • Reviews and approves Deviations, CAPAs (Corrective and Preventative Actions), and Change Controls.
  • Develops, trends, and manages key performance indicators and metrics related to Umoja Quality Systems.
  • Assists in the design and/or implementation of processes for batch record review and product disposition.
  • Partners directly with other functional areas by providing Quality-on-the-floor oversight and real-time support.
  • Other duties as assigned.

The successful candidate will have:

  • Bachelor's degree in Biochemistry, Molecular and Cellular Biology, Immunology, Biology, or a related life sciences or technical discipline.
  • Minimum of 8+ years of experience in an FDA-regulated industry.
  • Equivalent combinations of education, training, and relevant experience may be considered.
  • Strong working knowledge of cGMP requirements and Quality Systems.
  • Ability to independently assess quality and compliance risks and make sound, timely decisions.
  • Ability to provide effective on-the-floor Quality support in a dynamic manufacturing environment.
  • Strong understanding of good documentation practices and data-integrity principles.
  • Ability to interpret and apply regulatory requirements in a practical and risk-based manner.
  • Strong technical writing, investigation, analytical, and problem-solving skills.
  • Strong interpersonal and cross-functional collaboration skills.
  • Ability to appropriately challenge decisions while maintaining productive working relationships.
  • Strong verbal and written communication skills.

Preferred Qualifications:

  • Experience supporting viral-vector, cell-therapy, gene-therapy, biologics, or aseptic manufacturing operations.
  • Experience with batch record review and product disposition.
  • Knowledge of FDA regulations, EU GMP requirements, ICH guidelines, and applicable industry standards.
  • Previous experience participating in cGMP audits and inspections.

Physical Requirements:

  • Ability to gown aseptically and work in a Clean Room environment, if required.
  • Ability to work while gowned for extended periods of time, if required.
  • Ability to stand for extended periods of time to fulfill on-the-floor Quality duties, if required.
  • Use of laboratory equipment includes handling chemicals and biological materials.
  • Must have the ability to work around laboratories, manufacturing areas and equipment, and regularly lift 10-20 lbs. and periodically lift up to 50 lbs.
  • Ability to work occasional nights and weekends as needed.
  • Ability to primarily work onsite, working remotely when appropriate.

Salary Range: $105,060 - $129,780

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.