Summary Under general supervision, this role provides expertise in characterizing process optimization strategies and troubleshooting operational issues within manufacturing, pilot plant, or capital project environments.
The engineer applies fundamental engineering principles to design and implement system modifications, experiments, or capital projects while organizing and interpreting results to resolve operational challenges.
Responsibilities Serve as a technical expert for equipment or systems, providing troubleshooting support for daily operations to meet schedules or resolve complex problems.
Conduct routine audits of equipment and systems to ensure operational performance and regulatory compliance.
Collaborate with research, manufacturing, maintenance, process development, utilities, facilities, quality assurance, and validation teams to recommend and implement system modifications.
Assist project managers in completing design, engineering, and construction projects within schedule and budget constraints.
Work with consultants, architects, and engineering firms to develop standard design documents.
Evaluate quotes for equipment modifications or installations and generate project cost estimates and schedules.
Apply standard engineering techniques to solve technical problems of moderate scope and complexity.
Perform routine technical tasks and investigate variables to achieve clear and specific objectives.
Ensure compliance with GLP, GMP, and regulatory requirements.
Prepare and execute validation protocols.
Provide detailed technical reports, project updates, and recommendations.
Skills and Abilities: Strong problem-solving skills with the ability to analyze equipment conditions, understand process variables, and resolve technical issues.
Familiarity with control systems and their components (input, output, control).
Ability to operate specialized laboratory equipment and computers.
Excellent verbal communication and technical report writing skills.
Self-motivated with excellent learning skills and the ability to adapt to new technologies.
Proficiency in technical presentations, validation protocol writing, and managing changes.
Analytical and organizational skills with strong computer literacy.
Requirements Qualifications Master's degree in Engineering OR Bachelor's degree in Engineering with 2+ years of relevant experience.
Preferred Fields: Chemical Engineering, Mechanical Engineering, or Electrical Engineering.
Experience: Working knowledge of pharmaceutical/biotech processes.
Experience with GMP manufacturing operations or engineering operations.
Familiarity with validation processes and documentation in regulated environments.
Experience with equipment startup, troubleshooting, and PLC systems.
Knowledge of manufacturing equipment failure modes and utilities systems (e.g., valves, pumps).