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Process Engineer - Fill/Finish

The Opportunity

Reporting to the Associate Director of Process Technology and dotted line responsibilities to the project Design Lead, the role will provide project and process design support to the project team to ensure that the project and process requirements are implemented to specification, time, quality and within budget for a successful handover to the end user. You will also help develop project plans and contribute to project monitoring and control activities. You will utilize their underlying knowledge in aseptic processing and Fill/Finish to ensure the process design is captured appropriately to meet: Scope, Budget and Timelines.

You will be a member of the Process Technology team in Kankakee under the Global Process Engineering umbrella. You will join a team of Scientists and Engineers focused on fill and finish of a sterile drug product facility and that provides strategic technical direction to the manufacturing organization and project delivery team that allows the site achieve supply targets while maximizing capacity. As subject matter experts of the process, you will lead process design of capital project in the Fill/Finish processes as well as supporting existing operational challenges as they arise. Daily work will be onsite in the Kankakee plant and will require approximately 50% travel to support the project design and equipment manufacturing process.

The Role

  • Responsible for process design activities required to scope, develop, procure, construct and qualify new equipment and facilities required to meet production throughput demands.

  • Support/lead multi-disciplinary teams through project life cycle activities to deliver capacity expansion capabilities to meet global and local strategic requirements.

  • Responsible for completion of project lifecycle activities through turnover to routine commercial production. This role would continue to support new projects and existing commercial product upon completion of the project.

  • Ensure that key parameters for process monitoring are clearly identified during the project design. Upon turnover, a control strategy is created and necessary charting of these parameters (e.g. time series, control charts) are set up and transferred to the Operations team.

  • Participate in cross-functional, external plant operations teams, act as single point of contact (SPOC) for Engineering in such teams, engage broader organization to drive capability and lead investigations through the use of problem-solving tools.

Your skills and experience

  • Bachelor's degree required. Degree in Engineering or Science discipline preferred. Level of role determined by related industry experience (pharmaceutical/biotech operations preferred).

  • Minimum 5-6+ years of industry experience with aseptic processing and Fill/Finish experience.

  • E xperience leading multicultural and international teams.

  • Knowledge of cGMPs and manufacturing operations in FDA regulated facility.

  • Understanding of project management principles and project lifecycle phases. Knowledge of Commissioning and Qualification, Process Validation, and facility regulatory submission requirements.

#LI-Onsite

The expected base salary range for this position at hiring is $104,400 - $118,400. Please note this salary range reflects the minimum and maximum base pay that CSL expects to pay for this position at the listed location as of the time of this posting. Individual base salary for a successful candidate is determined by qualifications, skill level, experience, competencies and other relevant factors. In addition to base salary, total compensation for this role may also include incentive compensation and equity.

Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.

Our Benefits

CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.

Please take the time to review our benefits site to see what’s available to you as a CSL employee.

About CSL Behring

CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring .

We want CSL to reflect the world around us

As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.

Do work that matters at CSL Behring!

Average salary estimate

$111400 / YEARLY (est.)
min
max
$104400K
$118400K

If an employer mentions a salary or salary range on their job, we display it as an "Employer Estimate". If a job has no salary data, Rise displays an estimate if available.

What You Should Know About Process Engineer - Fill/Finish, CSL Behring

If you're passionate about driving innovation in the biopharmaceutical industry, then the Process Engineer - Fill/Finish position with CSL Behring in Kankakee County, IL, could be the perfect fit for you! In this vibrant role, you'll report to the Associate Director of Process Technology while also collaborating closely with the Design Lead. Your key responsibilities will entail providing top-notch project and process design support, ensuring that the project requirements are meticulously met regarding specifications, timelines, and budgets. You'll dive deep into the fascinating world of aseptic processing and Fill/Finish, ensuring that every aspect of the process design is captured accurately to meet defined scopes. Working in a dynamic team made up of brilliant Scientists and Engineers, your goal will be to contribute to the strategic direction of the manufacturing organization while also facing operational challenges head-on. You'll have the unique opportunity to lead the design of capital projects and maintain ongoing support for commercial products, making a tangible impact on improving global supply chain capabilities. Keep in mind, this role will involve daily onsite work at our Kankakee plant, with about 50% travel to support project design and equipment manufacturing. Join us at CSL Behring, where you’ll not only elevate your career but also play a vital role in the production of life-changing medicines!

Frequently Asked Questions (FAQs) for Process Engineer - Fill/Finish Role at CSL Behring
What are the primary responsibilities of a Process Engineer - Fill/Finish at CSL Behring?

As a Process Engineer - Fill/Finish at CSL Behring, your main responsibilities will include supporting project teams in designing processes that adhere to specifications, prompting the development of project plans, and monitoring project activities. You'll lead efforts in ensuring that capital projects in Fill/Finish processes are successfully scoped, developed, and implemented, supporting both new and existing commercial products.

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What qualifications do I need to become a Process Engineer - Fill/Finish at CSL Behring?

To qualify for the Process Engineer - Fill/Finish role at CSL Behring, you’ll need a Bachelor's degree in an Engineering or Science discipline, along with at least 5-6 years of relevant experience in the pharmaceutical or biotech sectors. Experience in aseptic processing, knowledge of cGMPs, and project management principles will set you apart as a strong candidate.

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How does CSL Behring support the career development of Process Engineers?

CSL Behring is dedicated to employee development, especially for roles like Process Engineer - Fill/Finish. You'll benefit from ongoing training opportunities, mentorship programs, and access to tools that enhance both technical skills and project management expertise, ensuring you have the resources necessary to thrive in your career.

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What can I expect regarding travel as a Process Engineer - Fill/Finish at CSL Behring?

As a Process Engineer - Fill/Finish at CSL Behring, you should expect approximately 50% travel associated with supporting project design and equipment manufacturing. This travel will offer you exposure to various project sites and ensure you're actively engaged in the processes you design.

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How does CSL Behring approach diversity and inclusion in the workplace for Process Engineers?

CSL Behring highly values diversity and inclusivity within its workforce, especially for roles like Process Engineer - Fill/Finish. The company actively seeks individuals from various backgrounds and promotes a culture where diverse perspectives enhance problem-solving and innovation across teams.

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Common Interview Questions for Process Engineer - Fill/Finish
Can you describe your experience with aseptic processing in a Fill/Finish environment?

In answering this question, highlight specific projects or experiences where you employed aseptic processing techniques. Discuss the challenges you faced, how you overcame them, and any relevant outcomes. Show your understanding of industry standards and safety regulations.

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What do you consider the most critical factors in designing Fill/Finish processes?

Focus on aspects such as compliance with cGMP regulations, efficiency, scalability, and safety. Discuss how you have applied these principles in previous roles to ensure successful process implementation.

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How do you approach project management when leading a Fill/Finish project?

Emphasize your knowledge of project management methodologies and tools. Discuss how you prioritize tasks, manage timelines, and communicate with multidisciplinary teams to ensure successful project completion.

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What strategies do you employ to resolve operational challenges in Fill/Finish processes?

Talk about specific problem-solving tools and methods you’ve used in the past, such as root cause analysis or Six Sigma methodologies. Provide an example that illustrates your proactive approach to tackling challenges.

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How do you ensure quality control during the process validation phase?

Describe your approach to quality assurance, including the protocols you follow during validation phases. Highlight any relevant metrics or standards you utilize to monitor process integrity.

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Can you share an experience where you led a diverse team in a Fill/Finish project?

Discuss your leadership style and how you adapt to support team members from different backgrounds. Share an example that showcases your ability to foster collaboration and drive project success.

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What are the key regulatory considerations you keep in mind while designing Fill/Finish processes?

Talk about your familiarity with FDA regulations and international compliance requirements. Mention specific instances where regulatory considerations influenced your design process.

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How do you stay updated with advancements in Fill/Finish technology?

Make sure to convey your commitment to professional development by mentioning industry publications, online courses, webinars, or conferences you attend to stay informed about new technologies and best practices in Fill/Finish.

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What software or tools do you use for process design and project management?

List specific software tools, like CAD programs, project management software, or data analysis tools, that you’re proficient in. Highlight how each has aided you in your previous projects.

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How would you handle a situation where a project is falling behind schedule?

Discuss your proactive measures for addressing delays, such as re-evaluating resource allocation, enhancing team communication, and collaborating with stakeholders to revise timelines. Provide an example to illustrate your problem-solving skills.

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Full-time, on-site
DATE POSTED
April 17, 2025

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