Under general supervision, the Process / Operations Engineer provides characterization of process optimization strategies and / or troubleshooting of operational issues in operations, manufacturing, pilot plant, or capital project environments. This role applies fundamental engineering principles to design and implement system modifications, experiments, and / or capital projects. The engineer organizes, analyzes, and interprets results to address operational challenges or engineering projects of moderate scope and complexity.
Responsibilities
- Provide solutions to a variety of technical problems of moderate scope and complexity.
- Evaluate, select, and apply standard engineering techniques and procedures under general supervision (with guidance for unusual problems).
- Perform assignments with clear and specific objectives requiring investigation of limited variables.
- Initiate and complete routine technical tasks.
- Act as a technical expert for equipment or systems regarding troubleshooting and daily operations support.
- Actively engage in operations when required to meet schedules or resolve complex problems.
- Routinely audit operational performance and regulatory compliance of equipment or systems of moderate complexity.
- Collaborate with cross-functional groups (research, manufacturing, maintenance, process development, utilities, facilities, QA, validation) to develop requirements and recommendations for system modifications.
- Support project managers in completing design, engineering, and construction projects within schedule and budget.
- Work with consultants, architects, and engineering firms on the development of standard design documents.
- Obtain and critique vendor quotes for equipment modifications or installations.
- Generate basic project cost estimates and schedules.
Requirements
Education Requirements
Master’s degree in Engineering, ORBachelor’s degree in Engineering + 2 years of engineering experience.Preferred Qualifications
Experience in the purification process of proteins.Familiarity with pharmaceutical / biotech processes.Knowledge of validation processes and documentation in highly regulated environments.Experience in investigations, troubleshooting, process improvements, and technical writing.Ability to operate specialized laboratory equipment and relevant computer systems.Understanding and application of GLPs and GMPs.Strong problem-solving and applied engineering skills.Ability to write technical reports and validation protocols.Effective verbal and written communication skills, including technical presentations.Skills in personal organization, analytical problem solving, computer literacy, and managing change.Benefits
1 year contract with possible extension