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Process Engineer

1 month ago

Andover, Massachusetts, United States Katalyst Healthcares and Life Sciences Full time
Job Title: Process Engineer

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
Requirements:
  • 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