Engineer
hace 1 mes
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.
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