Engineer Specialist

Job Description

Job Description

Under general supervision, the Engineer Specialist will play a key role in characterizing process optimization strategies and troubleshooting operational issues in the manufacturing, pilot plant, or capital projects environments. This position will involve applying basic engineering principles to system modifications, experiments, and / or capital projects. The engineer will collaborate with cross-functional teams to support operational excellence and ensure regulatory compliance in a GMP-regulated environment.

Responsibilities

• Troubleshoot and resolve a variety of technical problems of moderate complexity within manufacturing and production systems.
• Serve as a technical expert to equipment and systems, actively supporting daily operations and resolving complex issues as required.
• Routinely audit operational performance, ensuring compliance with regulatory standards and identifying areas for system improvement.
• Work closely with manufacturing, maintenance, research, process development, utilities, facilities, quality assurance, and validation teams to recommend and implement system modifications.
• Analyze equipment-related problems, understand the variables that impact processes, and propose solutions to resolve issues effectively.
• Work under the direct supervision of project managers to complete design, engineering, and construction projects within specified schedules and budget constraints.
• Collaborate with consultants, architects, and engineering firms on the development of design documents and equipment specifications.
• Obtain, review, and critique quotes for equipment modifications or installations, ensuring feasibility and cost-effectiveness.
• Generate project cost estimates and schedules, providing detailed and accurate documentation to support project execution.
• Ensure compliance with GMP, GLP, and other regulatory requirements in all engineering processes and activities.
• Provide support for validation activities, including writing validation protocols and assisting in validation execution.
• Contribute to equipment startup and troubleshooting, particularly in relation to control systems, failure modes, and operational performance.

Skills & Competencies

Requirements

Qualifications

Preferred Qualifications

Benefits