Responsibilities
- Serves as a lead core team member of a cross functional project team.
- Conducting studies directed toward the development of processes.
- Performs standard scientific assignments to evaluate results for validity and conformance to acceptable scientific methods.
- Independently determines requirements and acceptance criterion associated with testing performed.
- Applies deep knowledge of six sigma methodologies to assess product design and translate them into process specifications.
- Participates and consults with the internal and external scientific community.
- Deploys deep knowledge of manufacturing to suggest and implement creative solutions in process development and test method creation.
- Coordinates or performs validations and documents risk management activities to support regulatory submissions or product launches.
- Leverages expertise across projects and specialties to effectively accomplish assignments and identify and mitigate risks within a project.
- May serve as a team lead and have direct reports.
- Supports Quality process improvement initiatives.
Requirements
- Bachelor’s degree in relevant area.
- 6+ years of relevant medical device, pharmaceutical, or other regulated industry experience.
- Strong attention to detail and documentation practices.
- Ability to work independently in a small‑company environment.
- Effective communication and cross‑functional collaboration.
- Problem‑solving and investigative mindset.
- Strong knowledge of microbiological techniques and aseptic processing.
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