Manufacturing Process Engineer II

2 weeks ago

Triangle Township, United States Biogen Full time
Job Overview

The Manufacturing Process Engineer II is responsible for the design, specification, installation, commissioning, and validation of new process equipment. This role provides essential engineering support and troubleshooting for assigned process systems within a Good Manufacturing Practice (GMP) biological manufacturing environment, which may include areas such as Cell Culture, Harvest, or Purification.

Key Responsibilities

  • Support manufacturing operations by diagnosing and resolving process equipment issues while identifying opportunities for enhancements. Update preventative maintenance job plans, equipment standards, and specifications as needed.
  • Identify and assist with projects related to process equipment, including technology transfers and capital projects. Provide insights and guidance during tech transfer initiatives and evaluate process equipment, including validation requirements for change controls.
  • Draft and approve GMP workflows, including change controls, deviations, and corrective actions for equipment and automation-related modifications. Participate in relevant meetings and impact assessments.
  • Coordinate the development and management of process equipment and cleaning validation protocols, ensuring thorough tracking and oversight of time spent on the manufacturing floor. Design and develop validation protocols, offering support for equipment and automation design modifications, startup, and commissioning activities.

Candidate Profile

The ideal candidate is a process equipment engineer with a strong aptitude for troubleshooting and a desire to enhance site operations. You are enthusiastic about learning new technologies and thrive in a collaborative, cross-functional environment. Your role is critical in achieving project milestones, necessitating effective communication with both internal and external stakeholders. As a representative of the Manufacturing Engineering team, your decisions carry significant weight, and your commitment to delivering precise and timely results is paramount in ensuring efficient processes.

Qualifications

  • Bachelor's degree in engineering.
  • 0-2 years of experience in manufacturing, engineering, or validation, preferably within a biologics drug substance context.
  • Familiarity with bioreactor, centrifugation, chromatography, or viral/ultra-filtration unit operations is preferred.
  • Practical knowledge of GMP regulations and guidelines (ISPE, USP, PIC/S, Annex, ICH, etc.).
  • Proficiency in DeltaV, MS Word, MS Excel, MS PowerPoint, and MS Project.
  • Strong organizational, time management, and communication skills, both oral and written.
  • Willingness to work on-site and accommodate rotating shifts, on-call duties, and extended coverage as necessary.

Why Join Biogen?

At Biogen, we are dedicated to fostering a culture of excellence and innovation. As a mid-sized biotechnology company, we combine the stability of an established organization with an environment that encourages individual contributions. Our team is composed of talented and passionate professionals who have unique opportunities for growth and skill development. Together, we strive to deliver transformative medicines, with every role being vital to our mission.

We are committed to building a diverse and inclusive workplace that reflects the communities we serve. We believe that diverse backgrounds and perspectives strengthen our company and drive innovation. All qualified applicants will receive consideration for employment without regard to any protected status.

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