Process Engineer III

As a Process Engineer III at Repligen, your primary responsibilities include leading the installation and operational qualifications of process equipment, overseeing process validations (IQ/OQ/PQ), and generating essential documentation such as process flow diagrams and risk assessments. You'll also be responsible for investigating process deviations and implementing corrective actions, ensuring a continuous improvement culture driven by data analysis.

To become a Process Engineer III at Repligen, you should have a Bachelor’s degree or higher in Chemical Engineering or a related field. Additionally, having 5-8+ years of experience in chemical manufacturing is crucial, alongside a solid understanding of ISO standards and Good Manufacturing Practices (cGMP).

Absolutely! At Repligen, teamwork is vital for the success of a Process Engineer III. You will be working closely with cross-functional teams to ensure process objectives are met and that safety and quality standards are upheld throughout the engineering processes.

Key skills for a Process Engineer III at Repligen include a strong knowledge of process/equipment validation, a safety-first mindset, and experience using statistical tools for process control. Lean manufacturing and Six Sigma knowledge are also beneficial to help drive process improvements efficiently.

Beyond a competitive remuneration package, Repligen offers a yearly bonus, flexible working hours, and a stimulating environment that promotes a steep learning curve. Joining our international team provides the opportunity to contribute meaningfully to patient healthcare worldwide.

When answering this question, discuss specific instances where you led equipment and process validations, detailing the methodologies you used such as IQ, OQ, and PQ practices. Highlight the challenges you faced and how you overcame them to ensure compliance and quality in manufacturing processes.

Talk about your experience in creating and reviewing risk assessments, particularly HAZOP and FMEA. Explain how you identify potential risks and what protocols you follow to mitigate these risks, showcasing your understanding of safety and compliance.

Use the STAR method to frame your answer—describe the Situation, Task, Action, and Result. Be specific about the process improvement initiative you led, the data analysis involved, and the measurable impacts it had on efficiency or safety standards.

Highlight your systematic approach to troubleshooting, including root cause analysis techniques and how you document and communicate these deviations. Provide examples of successful corrective actions you've implemented in past roles.

Emphasize the importance of collaboration in your previous roles. Discuss how you facilitated effective communication between departments to achieve project goals and improve process efficiencies, ensuring that everyone was aligned and informed.

Detail your commitment to a safety-first mindset, including how you stay up-to-date with regulations, implement training programs, and foster a safety culture within your team. Give examples of how you've proactively contributed to maintaining compliance.

Discuss your proficiency with statistical tools and how you apply them in process control and data analysis. Explain how you use these tools to identify trends, issues, and areas for improvement in manufacturing processes.

Articulate the vital role that clear and concise communication plays in your work—whether it’s writing technical documents, presenting to stakeholders, or collaborating within teams. Give examples of how effective communication has led to successful outcomes.

Describe your proactive engagement with industry communities, continuous education, webinars, or certifications that keep you abreast of new technologies, regulations, and best practices in the field of chemical engineering.

Share your passion for life sciences and biopharma manufacturing. Discuss what specifically attracts you to Repligen's mission and how you see your skills and experiences aligning with the company’s goals to improve healthcare outcomes globally.