We are seeking a Process Development Scientist to lead and support scientific experimentation, equipment characterization, and validation activities within a regulated manufacturing or packaging environment. This role involves designing and executing experimental strategies, analyzing data, and developing robust protocols to support equipment implementation and process optimization. The ideal candidate will bring deep technical expertise, strong project management skills, and the ability to collaborate across multidisciplinary teams.
Key Responsibilities
- Conceive, design, and execute scientific experiments under general guidance.
- Analyze and interpret experimental data to assess impact on project goals.
- Develop and implement novel protocols to address specific technical challenges.
- Ensure studies are conducted in compliance with applicable guidelines and regulations.
- Monitor scientific literature and technology trends relevant to the role.
- Lead development and execution of equipment characterization strategies.
- Design and implement testing protocols, including SATs and challenge validations.
- Author technical reports, validation documentation, and risk assessments.
- Apply QRAES methodology to support risk-based decision making.
- Support new equipment installations through validation planning and execution.
- Collaborate with internal departments to support project execution and troubleshooting.
- Represent the department on project teams and contribute to cross-functional initiatives.
- Mentor junior staff and contribute to department-wide efforts such as safety and recruiting.
- Communicate project status and findings effectively to stakeholders.
Requirements
Education & Experience
- Doctorate degree
OR - Master’s degree with 5 years of scientific experience
OR - Bachelor’s degree with 6 years of scientific experience
Technical & Software Requirements
- Proficiency in Microsoft Word, Excel, and PowerPoint
- Strong knowledge of cGMP regulations and validation processes
- Experience with vision system technologies and inspection/packaging concepts
- Fully bilingual in English and Spanish
Preferred Qualifications
- Expertise in equipment and process characterization
- Experience developing testing strategies and validation protocols
- Strong technical writing and documentation skills
- Familiarity with risk assessment methodologies (e.g., QRAES)
- Ability to solve routine technical problems and manage change effectively
- Strong verbal communication, negotiation, and conflict resolution skills
- Project management experience in a regulated environment
Benefits
- 5-month contract
- Administrative Shift