Job Description
Job Description
The Plant Engineer will provide technical support in troubleshooting, process optimization, and implementation of system modifications in a GMP-regulated environment. Under general supervision, the engineer will apply fundamental engineering principles to solve moderate-scope technical challenges, support manufacturing operations, and contribute to capital and operational projects. This role requires collaboration across departments and the ability to provide hands-on support during manufacturing operations, investigations, and system evaluations.
Key Responsibilities :
- Serve as a technical resource for equipment, process, and system troubleshooting in manufacturing or pilot plant settings.
- Become actively involved in daily operations when required to meet production schedules or resolve complex issues.
- Routinely assess operational performance and regulatory compliance of manufacturing systems or equipment.
- Monitor process performance indicators and recommend or implement corrective actions as needed.
- Collaborate with departments such as Manufacturing, Process Development, Facilities, Maintenance, Quality Assurance, and Validation to define and implement system / process improvements.
- Support root cause analysis and problem resolution efforts related to equipment, processes, and quality events (e.g., deviations, CAPAs).
- Support capital projects including the design and implementation of system modifications and new installations.
- Assist in generating project cost estimates, schedules, and scopes of work.
- Interface with consultants, engineering firms, and vendors to review design documents and equipment specifications.
- Provide input and critique on quotes for equipment or system modifications.
- Assist project managers in delivering engineering and construction projects on time and within budget.
- Support the execution of GMP manufacturing / quality systems including equipment qualifications, process validations, SOP updates, and training programs.
- Ensure all work complies with regulatory standards (GLPs, GMPs) and company procedures.
- Prepare and maintain technical reports, protocols, and documentation as required.
- Organize, analyze, and present data / results from investigations or project activities.
Requirements
Required Qualifications :
Master’s degree in Engineering ORBachelor’s degree in Engineering with a minimum of 2 years of relevant engineering experiencePreferred Qualifications :
Educational background in Mechanical, Electrical, or Chemical EngineeringExperience with process or equipment troubleshooting in a regulated pharmaceutical or biotech environmentFamiliarity with GMPs, validation protocols, and manufacturing processesStrong technical writing, organizational, and documentation skillsProficient in technical presentations and verbal / written communication in English and SpanishAbility to operate laboratory and process equipment and interpret engineering dataExperience with software tools such as MS Office, equipment monitoring systems, and basic project management applicationsDemonstrated problem-solving, collaboration, and multitasking abilitiesBenefits
4-month contract with possible extensionNon-Standard Shift