Summary: Under general supervision, this role provides technical expertise in process optimization, operational troubleshooting, and/or the execution of capital projects within manufacturing, pilot plant, or operations environments.
The Operations/Design Engineer applies fundamental engineering principles to system design, troubleshooting, and process improvements while collaborating with cross-functional teams to achieve objectives.
Responsibilities: Solve technical problems of moderate scope and complexity using standard engineering techniques and procedures.
Perform technical assignments requiring investigation of limited variables to meet specific objectives.
Initiate and complete routine technical tasks and support operational and engineering projects.
Serve as a technical expert for equipment and systems, providing troubleshooting support to maintain schedules and resolve complex issues.
Audit operational performance and ensure regulatory compliance for moderate to complex equipment and systems.
Collaborate with cross-functional teams (research, manufacturing, maintenance, process development, facilities, quality assurance, validation) to develop system modifications and enhancements.
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.
Critique vendor quotes, generate project cost estimates, and create schedules for equipment modifications or installations.
Skills: Problem-solving and analytical capabilities.
Technical report writing and presentation skills.
Hands-on experience with specialized laboratory equipment.
Strong understanding of validation protocol execution.
Personal organization and adaptability to manage change.
Computer literacy and ability to leverage technology for self-learning.
Requirements Qualifications: Education: Master's degree OR Bachelor's degree in Engineering with 2+ years of engineering experience.
Preferred Fields: Chemical, Mechanical, or Electrical Engineering.
Experience: Preferably in GMP-related fields such as manufacturing or engineering operations.
Preferred Qualifications: Understanding of pharmaceutical/biotech manufacturing processes and validation protocols.
Experience with documentation in a regulated (GMP) environment.
Familiarity with manufacturing equipment, including valves, pumps, utilities, and control systems (e.g., PLC).
Experience in drug substance/API operations, equipment start-up, and troubleshooting.
Knowledge of failure modes and the ability to propose resolutions.