Job Information
Actalent Sr. Process Engineer in Pleasant Prairie, Wisconsin
Job Title: Sr. Process Engineer – Flexibles
Job Description
The Sr. Process Engineer – Flexibles leads high-impact projects in research and development and new product introduction, with a strong focus on blown film extrusion and converting for medical device and medical packaging applications. This role drives process development, optimization, and technical innovation from concept through commercialization while ensuring full compliance with regulatory standards and industry best practices. The position works cross-functionally with R&D, Quality, Manufacturing, and Commercial teams to deliver robust, scalable, and compliant processes that support new products and continuous improvement initiatives.
Responsibilities
Lead the development, optimization, and validation of processes for blown film extrusion and film converting used in medical device and healthcare packaging applications.
Drive R&D and New Product Introduction (NPI) projects from concept through commercialization, ensuring processes are robust, scalable, and compliant with applicable standards.
Execute and implement projects of significant impact for the organization, focusing on process excellence and technical innovation in polymer processing and film manufacturing.
Develop, write, and maintain technical documentation, including protocols and reports for IQ, OQ, and PQ, ensuring clarity, completeness, and regulatory compliance.
Plan and execute equipment installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) activities, including data collection, analysis, and final reporting.
Focus on converting operations by taking blown film from master rolls and defining processes to create finished bags with features such as holes, seals, and other customer-specific requirements.
Collaborate closely with R&D, Quality, Manufacturing, and Commercial teams to translate product requirements into robust manufacturing processes and specifications.
Develop and refine test methods and process control strategies to ensure consistent product quality and compliance with ISO, FDA, and GMP requirements.
Use SolidWorks to support tooling design, apply templates, and make design alterations that improve manufacturability and process performance.
Identify and implement process improvements that enhance yield, quality, efficiency, and cost-effectiveness within a regulated manufacturing environment.
Ensure all process engineering activities align with GMP, ISO 9000, and other relevant regulatory and quality system requirements.
Provide hands-on support on the production floor during trials, validations, and scale-up activities, troubleshooting process issues and implementing corrective actions.
Contribute technical expertise to risk assessments, design reviews, and change control processes related to new and existing products and processes.
Support training and knowledge transfer to operations and quality teams on new or updated processes, documentation, and validation requirements.
Travel up to approximately 20% of the time to support project implementation, supplier interactions, and cross-site collaboration as needed.
Essential Skills
Bachelor’s degree in an engineering or scientific discipline.
At least 7 years of relevant experience in process engineering, with a strong focus on blown film extrusion and film converting.
Minimum of 3 years of direct experience in a medical device or healthcare packaging environment.
Deep expertise in polymer processing, film manufacturing, and converting technologies.
Hands-on experience in regulated environments, including ISO, FDA, and GMP settings.
Expert-level experience with integrated extrusion systems and their application in medical or healthcare packaging.
Proven track record in R&D and New Product Introduction (NPI) projects within a regulated manufacturing environment.
Strong experience in test method development, including protocol generation, execution, and documentation.
Demonstrated ability to create, manage, and execute IQ, OQ, and PQ validation protocols and reports.
Proficiency in documentation writing for technical, validation, and regulatory purposes.
Experience with tooling design supported by advanced SolidWorks CAD knowledge.
Ability to work cross-functionally with R&D, Quality, Manufacturing, and Commercial teams to drive product and process excellence.
Willingness and ability to travel up to approximately 20% of the time.
Additional Skills & Qualifications
GMP and ISO 9000 training.
Experience in an ISO-regulated environment, preferably within the medical device industry.
Advanced SolidWorks experience, including use of templates and making design alterations for tooling and process improvements.
Familiarity with converting processes that transform blown film from master rolls into finished bags with features such as holes and seals.
Six Sigma Green Belt or equivalent process improvement certification is beneficial but not required.
Strong analytical and problem-solving skills, with the ability to troubleshoot complex process issues.
Effective communication skills to clearly present technical information and collaborate with cross-functional teams.
Ability to manage multiple high-impact projects simultaneously in a fast-paced, regulated environment.
Work Environment
This role operates within a regulated manufacturing and R&D environment focused on medical device and healthcare packaging applications. The Sr. Process Engineer works closely with cross-functional teams in laboratory, pilot, and production areas where blown film extrusion, converting equipment, and integrated extrusion systems are used. The position involves hands-on work with process equipment during trials, validations, and scale-up activities, as well as extensive use of SolidWorks and other engineering tools for tooling design and process documentation. The work includes adherence to GMP, ISO, FDA, and ISO 9000 standards, with a strong emphasis on rigorous documentation, validation, and quality systems. The role typically follows standard business hours, with flexibility required to support production trials and project milestones, and includes up to approximately 20% travel to support project implementation and collaboration at other sites or with external partners.
Job Type & Location
This is a Permanent position based out of Pleasant Prairie, WI.
Pay and Benefits
The pay range for this position is $100000.00 - $120000.00/yr.
401k, health, vision, dental HSA/FSA Life & Disability
Workplace Type
This is a fully onsite position in Pleasant Prairie,WI.
Application Deadline
This position is anticipated to close on May 1, 2026.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through:
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
Actalent is an equal opportunity employer.
About Actalent
Actalent is a global leader in engineering and sciences services. For more than 40 years, we’ve helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000+ extraordinary employees who connect their passion with purpose every day.
Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.