Job Description
Job Description
Under general supervision, the Associate Engineer – Operations & Process Optimization supports the characterization of process optimization strategies and troubleshooting of operational issues in manufacturing, pilot plant, and capital project environments. This role applies foundational engineering principles to system modifications, experiments, and project implementation, contributing to operational efficiency and compliance.
Key Responsibilities
- Troubleshoot and resolve moderate-scope technical issues in equipment and process operations.
- Audit performance and ensure regulatory compliance of moderate-complexity systems.
- Collaborate with cross-functional teams (manufacturing, maintenance, QA, validation, R&D) to identify system improvements and operational enhancements.
- Interpret and apply engineering science to production systems and process improvements.
- Assist in the design, evaluation, and execution of system modifications or capital projects.
- Participate in development of engineering specifications and standard design documentation.
- Gather and critique vendor quotes for system installations and modifications.
- Prepare basic cost estimates and project timelines.
- Support execution and documentation of validation protocols (IQ / OQ / PQ).
- Ensure all work complies with GMPs, GLPs, and internal quality standards.
- Operate specialized lab equipment and software tools as needed.
Core Competencies
Effective verbal and written communication.Strong organizational and time management skills.Ability to manage change and drive continuous improvement.Team-oriented with a proactive and adaptable approach.Requirements
Master’s degree in Engineering, ORBachelor’s degree in Engineering with 2+ years of relevant experienceChemical Engineering background preferred)
Preferred Qualifications
Experience in biotech or pharmaceutical manufacturing environments.Familiarity with process validation and regulatory documentation.Working knowledge of drug substance manufacturing operations.Experience conducting statistical analyses and interpreting technical data.Strong problem-solving and applied engineering skills.Proficiency in technical writing and basic technical presentations.Competency in :Equipment-specific troubleshootingProtocol writing and executionAnalytical problem solvingComputer literacy and data analysis toolsBenefits
2 year contract with possible extensionAdministrative Shift