Position SummaryThe
Senior Engineer is responsible for applying advanced engineering principles to support the design, optimization, and reliability of inspection systems and related processes. This role involves leading equipment improvement initiatives, supporting complex system modifications, and collaborating across multiple functional teams within a highly regulated environment.
Key Responsibilities- Apply sophisticated and diverse engineering principles to design and implement major system modifications, experiments, and process improvements.
- Apply standard engineering techniques and procedures to improve equipment reliability and performance.
- Interact and provide direction to technical resources such as Mechanics, Automation Techs and IS teams.
- Support operation, maintenance, and troubleshooting of automated and manual inspection equipment.
- Develop and execute engineering solutions related to inspection technologies, especially for parenteral products and glass containers.
- Lead or contribute to protocol development and execution in validation activities within a regulated environment.
- Collaborate with cross-functional teams including Research, Manufacturing, Process Development, Utilities, Facilities, Quality Assurance, and Validation to support system and facility modifications.
- Ensure proper documentation and adherence to compliance standards and procedures.
- Technical writing and communicate technical information effectively through written reports and verbal presentations in both English and Spanish.
- Support changing management initiatives and drive continuous improvement efforts.
Minimum QualificationsPhD in Engineering OR
Master's Degree in Engineering with 2+ years of relevant experience OR
Bachelor's Degree in Engineering (Mechanical, Electrical, or Industrial) with 4+ years of relevant experience.
Required Skills & Competencies- Strong knowledge of inspection technologies and equipment used in parenteral and glass container processes.
- Experience with maintenance and operation of automated and manual inspection systems.
- Basic understanding of validation processes and regulatory documentation requirements.
- Strong technical writing and verbal communication skills (English and Spanish).
- Excellent organizational, presentation, and problem-solving skills.
- Ability to manage multiple priorities and drive projects to completion.
- Effective collaboration and stakeholder management skills.
- Experience in a highly regulated environment (e.g., pharmaceutical, biotech, or medical devices) preferred.
