Biotech and Pharmaceutical, Continuous Improvement, Cross-Functional, Drug Manufacturing, Electricity, English Language, Equipment Validation, Identify Issues, Maintain Compliance, Manufacturing, Manufacturing Operations, Mechanical Engineering, Multilingual, Operational Support, Operational Support Systems (OSS), Problem Solving Skills, Process Improvement, Product Support, Regulatory Requirements, Spanish Language, System Operations, Technical Support
We are seeking a technical resource to
support Sterile Manufacturing Operations, with a focus on inspection
engineering activities and parenteral inspection technologies, supporting
ongoing operations, product transfers, and continuous improvement initiatives.
Key Responsibilities
- Lead inspection
engineering activities
- Develop
and implement new inspection technologies
- Provide
support for product transfers
- Deliver operational support of inspection systems for sterile/biologic
products
- Lead process
improvements
- Execute validation and line trials
- Troubleshoot inspection equipment
- Manage inspection-related projects to ensure compliance, quality, and
efficiency
Collaboration
- Collaborate
cross-functionally with manufacturing, engineering, quality, and
validation teams
- Ensure
alignment with site priorities and regulatory requirements
Requirements
Qualifications / Requirements
- Problem-solving
capabilities
- Experience
in pharmaceutical sterile manufacturing environments
- Scientist with experience in the inspection of serialized liquid parenteral products.
- Experience with syringe inspection systems and processes.
- Strong technical knowledge of inspection technologies and processes applied to liquid pharmaceutical products.
- Fully Bilingual (English & Spanish)
Education & Experience (Inferred Based on Industry
Standards)
- Bachelor’s
degree in Engineering (Mechanical, Electrical, Industrial, Chemical, or
related field) or applied sciences
- Approximately 5–10+ years of experience in sterile/biologic inspection systems
or inspection technologies
- Experience
with validation, equipment troubleshooting, and implementation of
inspection technologies