1

Biotech Process Engineer Jobs in Madison, WI (NOW HIRING)

Be Seen First

Engineering experience in a pharmaceutical, biotech, API, medical device, food, or similarly regulated manufacturing environment. * Ability to analyze process, equipment, and quality data; identify ...

Producing documentation to support medical device regulatory processes Who This Is For * Students ... biotechnology. Our global teams work every day to solve the world's most complex challenges by ...

Producing documentation to support medical device regulatory processes Who This Is For * Students ... biotechnology. Our global teams work every day to solve the world's most complex challenges by ...

Manufacturing Engineer

Waunakee, WI · On-site

$69K - $85K/yr

This is a great opportunity for an early-career engineer looking to develop hands-on experience in ... processes Travel * Less than 10% Business Overview Genus is an agricultural biotechnology pioneer.

This is a great opportunity for an earlycareer engineer looking to develop handson experience in a ... processes Travel * Less than 10% Business Overview Genus is an agricultural biotechnology pioneer.

This is a great opportunity for an earlycareer engineer looking to develop handson experience in a ... processes Travel * Less than 10% Genus is an agricultural biotechnology pioneer. We are a global ...

Manufacturing Engineer

Waunakee, WI · On-site

$69K - $85K/yr

This is a great opportunity for an earlycareer engineer looking to develop handson experience in a ... processes Travel * Less than 10% Business Overview Genus is an agricultural biotechnology pioneer.

Product Design Engineer, IoT

Madison, WI

$130K - $156.20K/yr

... processes for global standards such as FCC, CE, ISO, and potentially FDA 21 CFR Part 820 or ISO ... biotech. 2. Experience designing products from initial concept phase through installation and ...

Product Design Engineer, IoT

Madison, WI · On-site

$130K - $156.20K/yr

... processes for global standards such as FCC, CE, ISO, and potentially FDA 21 CFR Part 820 or ISO ... biotech. 2. Experience designing products from initial concept phase through installation and ...

Product Design Engineer, IoT

Madison, WI · On-site

$130K - $156.20K/yr

... processes for global standards such as FCC, CE, ISO, and potentially FDA 21 CFR Part 820 or ISO ... biotech. 2. Experience designing products from initial concept phase through installation and ...

Product Design Engineer, IoT

Madison, WI

$130K - $156.20K/yr

... processes for global standards such as FCC, CE, ISO, and potentially FDA 21 CFR Part 820 or ISO ... biotech. 2. Experience designing products from initial concept phase through installation and ...

... Agile engineering team, contributing to process automation, testing strategies, and design ... biotechnology. Our global teams work every day to solve the world's most complex challenges by ...

next page

Showing results 1-20

Biotech Process Engineer information

See Madison, WI salary details

$49.9K

$92.7K

$143.6K

How much do biotech process engineer jobs pay per year?

As of May 30, 2026, the average yearly pay for biotech process engineer in Madison, WI is $92,733.00, according to ZipRecruiter salary data. Most workers in this role earn between $75,100.00 and $103,800.00 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 job categories do people searching Biotech Process Engineer jobs in Madison, WI look for? The top searched job categories for Biotech Process Engineer jobs in Madison, WI are:
Infographic showing various Biotech Process Engineer job openings in Madison, WI as of May 2026, with employment types broken down into 100% Contract. Highlights an 100% In-person job distribution, with an average salary of $92,733 per year, or $44.6 per hour.
Process Engineer - API Manufacturing Remediation

Process Engineer - API Manufacturing Remediation

Automated Systems, Inc.

Madison, WI • On-site

$60 - $80/hr

Contractor

Medical, Dental, Vision, PTO

Posted 10 days ago

Be Seen First

After you apply to this job, you can share why you’re interested to jump to the top of the candidate list.


Job description

Process Engineer – API Manufacturing Remediation

Location: Greater Madison, WI area - onsite
Contract: 6+ month duration with potential for extensions
Automated Systems, Inc. is seeking a Process Engineer for a minimum 6-month on-site consulting assignment with an API manufacturer in the greater Madison, Wisconsin area. This role will support remediation and manufacturing improvement efforts at a biologically derived API site producing enzymes. The site also supports broader recovery and purification capabilities used in natural-product and biopharmaceutical processing. The selected engineer will work directly with manufacturing and quality teams on organ/raw-material receiving and initial processing, API-contact equipment condition, wet-cake handling and storage, drying operations, solvent-based extraction steps, precipitation, centrifugation, filtration, ultrafiltration, reverse osmosis, chromatography, and related remediation activities.

Key Responsibilities

 

  • Serve as a process and remediation engineer supporting API manufacturing operations, technical problem-solving, and quality-system improvement initiatives.
  • Partner with Manufacturing, Quality, Validation, Technical Services, Regulatory, and site leadership to investigate deviations, OOS results, complaints, and process failures, and help ensure appropriate technical follow-through.
  • Lead or support root-cause investigations using sound engineering and quality-risk-management principles; ensure investigations are data-driven, well-scoped, and extended appropriately to related lots, materials, processes, and systems where warranted.
  • Evaluate process equipment, materials of construction, contact surfaces, and maintenance practices to improve suitability for CGMP manufacturing and reduce contamination risk.
  • Support implementation of preventive maintenance, inspection, equipment monitoring, repair follow-up, and lifecycle improvements for manufacturing equipment and supporting infrastructure.
  • Plan and execute studies, trials, and technical evaluations in support of process improvements, CAPAs, validation activities, and manufacturing readiness.
  • Develop and revise technical documents such as protocols, reports, assessments, engineering justifications, operating procedures, scope documents, change controls, and remediation action plans.
  • Provide technical support for batch-impact assessments, retain-sample evaluations, and risk assessments associated with manufacturing events or equipment-related concerns.
  • Help strengthen contamination-control practices for animal-derived API operations, including practical controls for process variability, hold decisions, escalation, and disposition support.
  • Coordinate contractors, technicians, validation resources, and cross-functional contributors as needed to execute projects and remediation tasks.
  • Identify opportunities to improve methods, systems, and operating discipline, and help convert those improvements into standard practice.

 

Qualifications

  • Bachelor’s degree in chemical engineering, Mechanical Engineering, Biomedical Engineering, Industrial Engineering, or a related technical discipline.
  • Engineering experience in a pharmaceutical, biotech, API, medical device, food, or similarly regulated manufacturing environment.
  • Ability to analyze process, equipment, and quality data; identify key factors; and recommend practical corrective actions.
  • Interpersonal skills to negotiate priorities, reconcile differences, and maintain momentum in a cross-functional environment.
  • Ability to work independently, manage multiple assignments, and drive issues to closure without excessive direction.
  • Comfortable operating in a fast-paced project environment with shifting priorities and significant visibility.

Company Description

We are a dynamic, project oriented consulting company offering individuals a wide variety of technical challenges. We are currently experiencing rapid growth, and are in need of talented individuals. ASI offers top wages and excellent benefits. ASI is an equal opportunity employer.