Position SummaryWe are seeking a highly motivated
Senior Engineer to support engineering initiatives within a regulated manufacturing environment. This individual will be responsible for leading equipment and process-related projects, supporting new equipment design and implementation, executing validation activities, and driving engineering solutions that improve operational performance, quality, and compliance.
The ideal candidate will possess strong technical expertise in packaging equipment, engineering project management, equipment design, and validation processes. This role requires collaboration across multiple functions to ensure engineering projects are delivered safely, efficiently, and in compliance with applicable regulatory requirements.
Key Responsibilities- Lead engineering projects from concept through implementation and operational readiness.
- Support the design, specification, installation, and startup of new manufacturing and packaging equipment.
- Knowledge in Design of new equipment process.
- Develop engineering solutions to improve equipment reliability, efficiency, and performance.
- Manage project timelines, budgets, resources, and deliverables.
- Coordinate cross-functional project activities with Operations, Quality, Validation, Maintenance, and Manufacturing teams.
- Plan and execute equipment qualification and validation activities, including IQ, OQ, and PQ protocols.
- Ensure compliance with cGMP, quality standards, and applicable regulatory requirements.
- Generate and review engineering documentation, technical reports, specifications, protocols, and change control records.
- Support new product introductions and process optimization efforts.
- Collaborate with vendors, contractors, and external partners as required.
Required QualificationsMinimum Education & Experience
- Doctorate Degree in Engineering, OR
- Master's Degree in Engineering and 2 years of engineering experience, OR
- Bachelor's Degree in Engineering and 4 years of engineering experience.
Required Skills & Experience
- Knowledge of packaging equipment and packaging operations.
- Experience with the design and implementation of new equipment and manufacturing processes.
- Knowledge of engineering project management principles and execution.
- Experience supporting equipment and validation process activities.
- Experience within the Medical Device and/or Pharmaceutical industry.
- Strong problem-solving and analytical skills.
- Excellent technical writing and documentation skills.
- Ability to work effectively in a cross-functional team environment.
- Fully bilingual in English and Spanish (written and verbal).
Work ScheduleShift: First Shift (8:00 AM - 5:00 PM)
