Process Engineer

About the Role

We're seeking an experienced Process Engineer to provide technical leadership for the development and scale-up of aseptic manufacturing processes supporting innovative pharmaceutical and combination-device products. In this highly visible consulting engagement, you'll help define the future state of aseptic operations by translating early feasibility findings into robust process designs, equipment requirements, contamination-control strategies, and manufacturing solutions. You'll work closely with technical stakeholders, equipment vendors, and project teams to ensure manufacturing approaches are scalable, compliant, and aligned with current industry best practices.

Responsibilities

• Lead technical efforts supporting aseptic process development, equipment selection, scale-up, qualification, and validation activities.
• Translate feasibility study outcomes into practical process, equipment, and facility requirements that support future manufacturing operations.
• Develop contamination-control strategies for aseptic assembly, fill/finish, and combination-product manufacturing processes.
• Define and author User Requirement Specifications (URS) for aseptic processing equipment and controlled-environment workstations.
• Evaluate, specify, and support implementation of Biological Safety Cabinets (BSCs), ISO 5 / Grade A environments, and associated contamination-control technologies.
• Conduct and facilitate risk assessments, including process FMEA activities, to identify risks and establish effective mitigation strategies.
• Partner with equipment suppliers and technology providers to evaluate decontamination, sterilization, and aseptic processing solutions.
• Support development of handling, transfer, packaging, and assembly controls for pre-sterilized components.
• Provide technical guidance during design reviews and stakeholder discussions.
• Assess contamination risks, environmental excursions, and process vulnerabilities while recommending effective control measures.
• Support equipment and process strategies that align with EU GMP Annex 1 and industry best practices.

Requirements

• Significant experience supporting aseptic manufacturing, aseptic processing, fill/finish operations, or combination-product manufacturing within regulated pharmaceutical, biotechnology, or medical device environments.
• Hands-on experience developing processes from early-stage concept through qualification and validation.
• Expertise with ISO 5 / Grade A environments, Biological Safety Cabinets (BSCs), or other controlled-environment manufacturing systems.
• Experience developing User Requirement Specifications (URS) and equipment requirements for aseptic manufacturing operations.
• Strong knowledge of contamination control principles and aseptic process design.
• Demonstrated experience performing and leading risk assessments, including pFMEA or similar methodologies.
• Experience collaborating with equipment vendors, contract manufacturers, and technical stakeholders.
• Working knowledge of EU GMP Annex 1 requirements and their application within modern aseptic manufacturing environments.
• Ability to identify contamination risks and translate technical findings into practical solutions and design requirements.
• Strong communication and presentation skills with the ability to influence multidisciplinary teams and clients.

Preferred Qualifications

• Experience supporting aseptic fill/finish operations or combination-product manufacturing programs.
• Familiarity with novel decontamination or sterilization technologies.
• Experience conducting feasibility studies and translating findings into manufacturing strategies.
• Experience supporting facility, equipment, or line design projects.
• Consulting, subject matter expert, or technical leadership experience.
• Experience interacting with regulators, auditors, or customers in highly regulated environments.

Pay

The pay range for this position is $40.00 - $110.00/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.

Benefits

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)

Schedule

This is a part-time, contract position based in Hudson, WI. The role is fully onsite.