Senior Facilities Engineer

2 weeks ago

Triangle Township, United States Biogen Full time
Job Overview

Position Summary

The Senior Facilities Engineer plays a crucial role in providing technical engineering support and validation for plant utilities and facility operations. This position is integral to cross-functional teams aimed at enhancing and optimizing existing processes. Collaborating with various departments such as Utilities, Manufacturing, Process Engineering, and Maintenance, this role ensures the validation of all Good Manufacturing Practice (GMP) assets. Responsibilities include the design, specification, installation, commissioning, and qualification of new equipment, alongside writing and executing User Requirement Specifications (URS) and protocols.

Key Responsibilities

  • Assist in Facilities operations by diagnosing issues and proposing enhancements to equipment systems. Update standards, drawings, and specifications as required. Develop validation protocols and provide expertise for associated equipment and automation design modifications. Author deviations, Corrective and Preventive Actions (CAPAs), and change control records within a GMP framework.
  • Support capital and operational expenditure projects related to equipment, including scoping, modifications, design reviews, change controls, construction support, commissioning, and validation.
  • Develop and implement equipment commissioning and qualification (validation) activities.
  • Represent the department and actively engage in cross-functional/global teams to resolve issues, implement changes, and enhance existing processes.
  • Complete assigned tasks under the guidance of the Facilities Engineering Manager.
  • Oversee small capital projects.
  • Maintain personal training, goal setting/completion, compliance workflow activities, and progress tracking.

Candidate Profile

The ideal candidate is an experienced validation engineer with a strong background in developing Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) documentation. A passion for working in a collaborative environment to facilitate validation project execution is essential. The candidate should possess a solution-oriented mindset and a commitment to continuous improvement, with a keen eye for cost-saving opportunities and safety enhancements. As a representative of the Facilities Engineering team, the role carries significant responsibility, as errors in decisions or recommendations may lead to delays and resource allocation issues.

Qualifications

  • Bachelor's degree in Engineering with a minimum of 2 years of relevant experience.
  • Practical understanding of FDA GMP and EMA regulations.
  • Proficiency in MS Word, MS Excel, MS PowerPoint, MS SharePoint, and MS Project.
  • Experience in Plant Utility and chamber validation.
  • Strong verbal and written communication skills.
  • Willingness to work extended shifts or weekends as needed.

Preferred Qualifications

  • Familiarity with Kaye and LIVES validation data loggers.
  • Experience in a biotechnology or pharmaceutical manufacturing setting.
  • Proven experience in writing deviations and conducting investigations.
  • Project management experience.

Why Join Biogen?

At Biogen, we are dedicated to fostering a culture of excellence and innovation. As a mid-sized biotechnology company, we offer the stability and resources of an established organization while encouraging individual contributions that make a significant impact. Our team comprises some of the most talented and passionate professionals, providing unparalleled opportunities for learning, growth, and skill development. Together, we strive to deliver life-changing medicines, with every role being vital to our mission. We value diversity and are committed to creating an inclusive environment that reflects the communities we serve.

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