Process Engineer

Job Title: Process EngineerJob DescriptionThe Process Engineer will provide hands-on engineering support for GMP manufacturing operations at our Roseville facility. This role focuses on developing, improving, characterizing, troubleshooting, validating, and transferring manufacturing processes. The Process Engineer collaborates closely with Manufacturing, Quality, Validation, R&D, and other Technical Operations functions.

Responsibilities

• Provide day-to-day technical engineering support for GMP manufacturing processes.
• Develop, characterize, and optimize manufacturing processes with an emphasis on process robustness, repeatability, yield, capacity, and manufacturability.
• Troubleshoot manufacturing and process issues, leading or supporting root cause investigations and corrective actions.
• Design and execute engineering studies to understand critical process parameters and establish appropriate operating ranges.
• Support the introduction, scale-up, and transfer of new or modified manufacturing processes into production.
• Author and execute protocols and technical documentation supporting process qualification/validation and equipment qualification.
• Partner with Validation on IQ/OQ/PQ, process validation, and implementation of new or transferred manufacturing processes.
• Support investigations associated with deviations/nonconformances, CAPAs, and change controls.
• Evaluate manufacturing data to identify process trends, improvement opportunities, and potential sources of variation.
• Collaborate cross-functionally with Manufacturing, Quality, Validation, and R&D/Product Development to transition processes into sustainable GMP manufacturing.
• Provide hands-on support during engineering builds, validation runs, and manufacturing troubleshooting.
• Develop or update manufacturing documentation, procedures, reports, and other technical documentation.
• Support continuous improvement initiatives related to manufacturing efficiency, quality, capacity, and process reliability.

Essential Skills

• Bachelor's degree in Engineering or a closely related technical discipline.
• 3+ years of process/manufacturing engineering experience in pharmaceutical, biotech, medical device, or another highly regulated manufacturing environment.
• Experience in a GMP regulated manufacturing environment.
• Strong hands-on manufacturing process troubleshooting experience.
• Demonstrated experience with process characterization, process optimization, and root-cause investigation.
• Experience supporting process validation and/or IQ/OQ/PQ.
• Experience creating and executing engineering studies, protocols, and technical reports.
• Working understanding of deviations, CAPAs, change controls, and nonconformance investigations.
• Experience working cross-functionally with Manufacturing/Operations, Quality, and Validation.
• Strong technical writing and documentation skills.
• Ability to apply engineering judgment and risk-based problem solving to manufacturing problems.

Additional Skills & Qualifications

• Pharmaceutical or biotechnology manufacturing experience.
• Previous experience transferring a process from development/R&D into manufacturing.
• DOE, statistical analysis, process capability, or data-driven process optimization experience.
• Experience with equipment commissioning/qualification.
• Experience scaling manufacturing processes or improving production capacity/yield.
• Lean / Continuous Improvement experience.
• Experience operating at the intersection of Process Engineering and Validation.
• Experience with biologics, microbiome products, or other manufacturing processes involving biologically derived material.

Work EnvironmentThis is an onsite role, requiring presence on the shop/manufacturing floor, but not in the lab. The position involves a standard 40-hour work week with flexible start and end times. The dress code is business casual. Job Type & LocationThis is a Contract to Hire position based out of Saint Paul, MN. Pay and BenefitsThe pay range for this position is $53.00 - $60.00/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits

available for this temporary role may include the following:

Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave) Job Type & LocationThis is a Contract to Hire position based out of Saint Paul, MN. Application DeadlineThis position is anticipated to close on Nov 18, 2026. Workplace TypeThis is a fully onsite position in Saint Paul,MN.About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

San Francisco Fair Chance Ordinance:

Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector:

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI):

We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.