Engineer I

Responsibilities

• Support system reliability and operational optimization efforts.
• Identify system performance risks (e.g., single point of failure or obsolescence) and implement risk reduction strategies.
• Lead and execute improvement efforts, including identifying cycle reduction time opportunities, efficiency gains, and yield improvement opportunities.
• Support technical investigations, root cause analysis, and equipment troubleshooting activities.
• Apply structured problem-solving methodologies with guidance.
• Analyze data and assist in developing engineering solutions using data techniques and methodologies (e.g., Statistical Process Control, Six Sigma, predictive maintenance analysis, etc.).
• Support new product and technology introductions by assisting with engineering assessments, equipment modifications, and execution of engineering runs.
• Collect, organize, analyze, and present results for operational issues and engineering projects of small scope and complexity.
• Provide onsite day-to-day technical support for equipment and process troubleshooting.
• Apply process engineering principles to support the design, specification, installation, startup, and validation of process equipment and systems.
• Assists with project activities by performing engineering studies and assessments for process equipment systems.
• Translate user and process requirements into engineering documentation and support design development in alignment with standard engineering practices.
• Communicate effectively with supervisors, cross-functional teams, and support staff to escalate issues and contribute to solutions.
• Support a safe working environment by aligning with all pertinent environmental health/safety practices, rules, and regulations.

Requirements

• Masters degree 2 years of Engineering experience
• OR Bachelors degree and 4 years of Engineering experience
• OR Associates degree and 6 years of Engineering experience
• OR High school diploma / GED and 8 years of Engineering experience

Preferred Qualifications

• Bachelors degree in Chemical Engineering, Mechanical Engineering, or Bioengineering preferred
• Direct experience with regulated environments (e.g., FDA, cGMP, OSHA, EPA, etc.) is preferred.
• Subject Matter Expert and hands-on experience with complex manufacturing process equipment including sophisticated troubleshooting, reliability and performance improvements, and design optimization.
• Direct experience in equipment engineering and problem solving for cleaning, centrifuges, chromatography systems, and/or filtration systems.
• Solid understanding and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes, facilities, and equipment. Candidate should be experienced in corrective and preventative actions, and commissioning practices.
• Experience supporting design and startup engineering directly related to bulk biopharmaceutical production including process equipment and facilities design, procurement, construction, startup, and validation is preferred.
• Demonstrates independence, strong self-motivation, and organization, with the ability to manage multiple priorities in a project-based environment; effective in communication, facilitation, and collaboration.
• Demonstrates a strong team-oriented mindset and actively contributes to a collaborative culture that supports effective decision-making.
• Applies a continuous improvement mindset in daily activities and promotes a strong commitment to safety in all aspects of work.
• Ability to apply sophisticated and diverse engineering principles to the design and implementation of major system modifications, introduction of new equipment, processes, and capital projects. Develop technical solutions to sophisticated problems requiring the regular use of resourcefulness and creativity.
• Develops contingency plan for potential obstacles or setbacks
• Mentorship experience with peers or new team members on complex systems, equipment, machines, and/or processes within their area of expertise.
• Demonstrates interest in continuous learning opportunities around new tools, techniques, and configurations to enhance their analytical abilities.
• Strong leadership, technical writing, and communication/presentation skills are required.
• Required flexibility to support 24/7 operations, including scheduled weekend shifts, after-hours coverage, and on-call rotation.