Engineer - Process Optimization

Job Description

Under general supervision, the Engineer supports process optimization, system troubleshooting, and capital project execution across manufacturing, operations, pilot plant, and facilities. This role applies engineering principles to resolve moderately complex technical issues, design system improvements, and assist in capital projects while ensuring regulatory compliance and operational efficiency.

Key Responsibilities

Troubleshoot process and equipment issues to support day-to-day manufacturing.

Act as a technical expert for equipment and systems; participate directly in operations as needed.

Audit equipment and systems for operational performance and regulatory compliance.

Collaborate with cross-functional teams including manufacturing, quality assurance, facilities, validation, and process development to define and implement system improvements.

Assist project managers in completing design, engineering, and construction activities within schedule and budget constraints.

Collaborate with external consultants, architects, and engineering firms on design documentation.

Support capital projects by gathering equipment quotes, estimating costs, and generating implementation schedules.

Perform experiments and system evaluations with clearly defined objectives.

Collect, analyze, and interpret data related to engineering and operational issues.

Present findings and recommendations in a clear and structured format.

Core Competencies

Applied engineering and troubleshooting

Technical report and validation protocol writing

Verbal communication and technical presentation skills

Analytical problem-solving and computer literacy

Ability to manage change and stay organized in a dynamic environment

Requirements

Education & Experience

Master’s degree in Engineering, OR

Bachelor’s degree in Engineering with minimum 2 years of relevant engineering experience

Preferred Qualifications

Working knowledge of pharmaceutical or biotech manufacturing processes

Familiarity with aseptic operations (e.g., filling and sterile support systems)

Understanding of validation processes, GMP/GLP documentation, and regulatory environments

Hands-on experience with maintenance systems, asset management, and engineering reliability practices

Data analysis and problem-solving skills to address technical issues and identify improvements

Experience with laboratory or process equipment and related computer systems

Benefits

Administrative Shift

1 year contract with possible extension

Full-time