Sr Engineer I, Facilities

4 days ago

Durham, United States Biogen Full time
Job Description

Provides engineering technical support and troubleshooting for analytical instrumentation. Participates in multi-functional teams to implement changes and improve on existing processes. This position partners with other teams including technical development, manufacturing sciences, manufacturing, engineering, maintenance, and others to measure, target and improve reliability of all assets. Supports design, specification, installation, commissioning, and qualification of new equipment and analytical instrumentation including URS, protocol writing and execution. Supports technical development of Instrumentation & Controls (I&C) maintenance technicians and junior engineers. The role requires the knowledge / use of multiple control systems (Empower, LabX, Poccelerator (Siemens), Finesse) for troubleshooting and improvement. Participates and leads large engineering projects with minimal supervision and direction. Partners with project managers to track costs, resources, and adherence to timelines.

What You Will Do

  • Provide instrumentation and analytical instrumentation subject matter expertise applied to specify instruments, develop site standards, ensure manufacturing and support systems are operational.
  • Bridge the gap between automation and metrology, create standards for control of equipment, create controls for calibration requirements.
  • Support facilities and manufacturing operations by troubleshooting issues and identifying equipment/instrumentation improvements.
  • Develop validation protocols, provide expertise to associated equipment & instrumentation design modifications. Author deviations, CAPA’s and/or change control records in a GMP environment.
  • Lead I&C projects, procurement, implementation to maintain site functions. Ensure commissioning and validation protocols and developed and executed per project plan.
  • Represent department and lead/participate in cross-functional teams to address issues, implement change and improve existing processes.

Who You Are

You are an experienced analytical instrumentation engineer who likes to troubleshoot equipment, lead investigations and identify and implement improvements to increase system reliability, compliance and efficiency. You are also passionate about learning new technologies and working in a cross-functional environment. You are accountable for achieving milestones in equipment projects, involving frequent internal and external communication. As a representative of the Facilities Engineering organization, your role carries the weight of potential delays and extra resource allocation if errors occur in your decisions or recommendations. Your commitment lies in delivering accurate and timely results, ensuring efficient processes to prevent setbacks.


Qualifications

  • BS in Electrical, Chemical, Mechanical or related engineering field.
  • 5 years transferrable experience.
  • Practical knowledge of the application of FDA GMP and EMA regulations.
  • Expert in analytical instrumentation HPLC, UPLC, pH/Conductivity meters, balances, scales
  • Experience with pharmaceutical manufacturing and scientific support equipment instrumentation.
  • Ability to Configure Instrumentation & Control hardware including laboratory instrumentation and related software (i.e. Delta V, DCS, SCADA, DAS, LIMS, LabX “Smart” Instrumentation and PLC systems).
  • Ability to read and understand control panel wire diagrams
  • Competency in MS Word, MS Excel, MS Power Point MS SharePoint, and MS Project.
  • Excellent oral and written communication skills.
  • May be asked to work extended shifts or weekends.

Preferred Qualifications

  • Low voltage control panel wiring and troubleshooting
  • Other support instrumentation experience preferred.
  • Experience defending facilities procedures and practices to regulatory authorities.
  • Experience in GMP biotechnology/pharmaceutical manufacturing environment.
  • Validation experience.


Additional Information

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.

All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.

 

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