Position SummaryWe are seeking a highly motivated
Senior Engineer to support engineering initiatives related to manufacturing, packaging systems, equipment design, validation activities, and capital projects within a regulated pharmaceutical or medical device environment. The successful candidate will lead and support engineering projects, ensure compliance with quality and regulatory requirements, and drive continuous improvement efforts to optimize operational performance.
Key Responsibilities- Lead and support engineering projects from concept, design, implementation, qualification, and closure.
- Provide technical expertise in packaging equipment, including troubleshooting, optimization, and lifecycle management.
- Support the design, specification, installation, and startup of new equipment and manufacturing processes.
- Develop and execute engineering strategies to improve reliability, efficiency, and compliance.
- Coordinate and manage project activities, timelines, budgets, and deliverables.
- Author, review, and approve engineering and validation documentation, including protocols and reports.
- Ensure compliance with applicable GMP, safety, environmental, and regulatory requirements.
- Collaborate with cross-functional teams including Manufacturing, Quality, Validation, Maintenance, and Operations.
- Identify and implement continuous improvement opportunities related to equipment performance and process efficiency.
- Provide technical assessments, risk evaluations, and engineering solutions to support business objectives.
QualificationsCandidates must meet one of the following education and experience requirements:
- Doctorate degree in Engineering; OR
- Master's degree in Engineering and two (2) years of engineering experience; OR
- Bachelor's degree in Engineering and four (4) years of engineering experience.
- Bachelor's degree in Engineering and five (5) or more years of engineering experience.
- Strong knowledge of packaging equipment and manufacturing systems.
- Experience in the design and implementation of new equipment and process technologies.
- Experience managing engineering projects.
- Knowledge of equipment qualification and validation processes (IQ/OQ/PQ).
- Experience working in Medical Device and/or Pharmaceutical manufacturing environments.
- Knowledge of GMP regulations and industry standards.
- Strong problem-solving, analytical, and project management skills.
- Excellent verbal and written communication skills.
- Fully bilingual in English and Spanish.
Shift: 8:00 AM - 5:00 PM
Work Schedule: Overtime may be required based on business needs.
