Job Description As a member of the Development Supply Chain Engineering and Facility Reliability organization, position will be responsible for delivering engineering services in a biopharmaceutical manufacturing facility.

Responsibilities

  • Application of engineering principles to ensure that the manufacturing production goals and targets are met.
  • Support of new technology introductions by performing engineering assessments, implementing equipment modifications, and leading/delivery NTI projects.
  • Ensure the logical, systematic translation of design requirements and constraints into process equipment/system solutions.
  • Assist with project definition by performing engineering studies and assessments for process equipment systems, clean utilities, and production facility improvements.
  • Analyze problems, develop and propose engineering solutions in a scientific manner using data-driven techniques and analyses (e.g. Statistical Process Control, Six Sigma, predictive maintenance analysis, etc.)
  • Represent clinical operations within key corporate networks and teams
  • Lead implementation of key department goals and initiatives
  • Support site capital projects and programs as necessary
  • Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations.

Basic Qualifications

Doctorate degree OR Master’s degree and 3 years of engineering experience OR Bachelor’s degree and 5 years of engineering experience OR Associate’s degree and 10 years of engineering experience OR High school diploma / GED and 12 years of engineering

Preferred Qualifications

  • Bachelor’s degree in Biomedical Engineering, Biochemical Engineering, Chemical Engineering, Electrical Engineering, Computer Science or Mechanical Engineering
  • 5+ years of engineering experience with in an operations/manufacturing environment
  • Demonstrated ability to translate production processes and user requirements into detailed designs aligned with industry practices
  • Ability to apply knowledge of engineering principles and practices outside of discipline expertise to a broad variety of assignments in related fields
  • Ability to employ advanced techniques within area of engineering expertise.
  • Multi-disciplinary engineering background/experience
  • Direct experience with regulated environments (e.g. cGMP, OSHA, EPA, etc.)
  • Detailed understanding of industry regulations and ability to interpret in establishing current practices.
  • Hands-on experience with manufacturing process equipment including advanced troubleshooting, reliability and performance improvements, and design optimization.
  • Ability to apply engineering principles to the design and implementation of system modifications, introduction of new processes. Develop technical solutions to complex problems requiring the regular use of ingenuity and creativity.
  • Strong leadership, technical writing, and communication/presentation skills.
  • Work schedule flexibility as required to support 24/7 operations, requiring occasional after-hours engineering coverage.
  • Working knowledge and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes, facilities, and equipment. Candidate should be experienced in change control, non-conformances, corrective and preventative actions, and validation practices.
  • Experience in design and startup engineering directly related to bulk biopharmaceutical production including facility design, procurement, construction, startup, and validation is preferred. Equipment acquisition and design engineering experience is desired.
  • Independent, self-motivated, organized, able to multi-task in project environments, and skilled in communication, facilitation, and collaboration. Individual must be a team player prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making.

Desired Skills and Experience

See application page for details