Process Engineer

Job Description

Job Description

Process Engineer (Part-Time Hours)

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. This is an ideal opportunity for a seasoned aseptic processing professional who enjoys solving complex technical challenges, influencing critical design decisions, and helping bring next-generation products to market.

As the subject matter expert for aseptic processing, you'll play a key role in developing manufacturing strategies and ensuring that contamination-control principles are integrated throughout equipment and process design.

• 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.

• 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.

• 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.

This is a Contract position based out of Hudson, WI.

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.

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)

This is a fully onsite position in Hudson,WI.

This position is anticipated to close on Sep 6, 2026.

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 withoutregard to race, sex, age, color, religion, national origin, veteran status, disability,sexual orientation, gender identity, genetic information or any characteristic protectedby law.

If you would like to request a reasonable accommodation, such as the modification oradjustment of the job application process or interviewing process due to a disability,please email View email address on ziprecruiter.com for other accommodation options.

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

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as acondition of employment or continued employment. An employer who violates this lawshall 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 applicationsand qualifications, but final decisions are made by our hiring team. By applying, youacknowledge and agree that your application may be reviewed using AI tools.