Process Engineer
3 days ago
Join Katalyst Healthcares and Life Sciences as a Process Engineer and take on a challenging role in our manufacturing operations team.
About the Role:We are seeking a highly skilled Process Engineer to join our team in a GMP manufacturing environment. As a Process Engineer, you will be responsible for executing the manufacturing process, leading troubleshooting activities, and implementing process improvements.
Key Responsibilities:- Execute the manufacturing process in a multi-product cGMP facility
- Lead and oversee troubleshooting activities, tech transfer, and start-up activities
- Analyze and interpret process data to identify and implement complex process improvements
- Contribute to the completion of projects and manage own time to meet agreed targets
- Understand business drivers for Pharmaceutical and make decisions within organization's guidelines and policies
- Serve as technical support within your assigned group and collaborate with outside groups as needed
- Prepare comprehensive responses to audit findings and ensure smooth communication during audits
- Oversee Corrective and Preventive Actions (CAPAs) and ensure timely implementation and effectiveness
- Facilitate and initiate change control processes, including PTCs and EM-PTCs
- Collaborate with other departments to address corrective actions stemming from audits and inspections
- Conduct risk assessments and participate in revisions to ensure continuous improvement in compliance efforts
- Provide support for Quality Assurance Reviews (QAR) and Corrective and Preventive Action (CAPA) plans
- Lead and support in environmental and facility compliance activities, ensuring adherence to regulations and company standards
- High School Diploma (or Equivalent) and 8 years of relevant experience
- OR an associate's degree with 6 years of experience
- OR a bachelor's with at least 2 years of experience
- OR Master's with more than 0-1 year of experience
- Good verbal communication and ability to coach and provide guidance to others
- Computer literate, with skills in Microsoft Applications and process tracking software
- Able to work individually and in a team environment
- Master's degree and relevant pharmaceutical experience
- Continuous Improvement or Project Management Certifications
- Previous experience in a GMP manufacturing environment
- Familiarity and experience with mammalian cell culture, centrifugation, and ultrafiltration
- BA/BS in chemical engineering, biology, biochemistry, or related science or engineering field
- Minimum of 4+ years relevant experience with an engineering degree or, MS +3 yrs
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