Position Overview
The Senior Process Engineer will be responsible for leading the development, optimization, and scale-up of manufacturing processes for personal care and Over-the-Counter (OTC) products, with a focus on sunscreens and skincare formulations. The role requires a strong technical background in chemical engineering, process design, and continuous improvement to ensure the efficient, safe, and high-quality production of a diverse range of products. The successful candidate will work cross-functionally with R&D, Quality, and Production teams to support new product introductions, resolve process challenges, and drive process innovation.
Key Responsibilities
- Process Development & Optimization:
- Design, develop, and optimize scalable manufacturing processes for personal care and OTC products, ensuring compliance with cGMP and FDA regulations.
- Develop robust process documentation including Process Flow Diagrams (PFDs), Standard Operating Procedures (SOPs), and Work Instructions.
- Evaluate and optimize mixing, blending, emulsification, and filling processes for a variety of skincare and sunscreen formulations.
- New Product Introduction (NPI):
- Collaborate closely with R&D teams to ensure seamless scale-up from bench-scale to full-scale production.
- Conduct process trials, validation runs, and pilot batches to establish reliable manufacturing processes for new formulations.
- Lead the technical transfer of new products to production and provide technical support for troubleshooting.
- Process Improvement:
- Identify opportunities for process improvements to enhance efficiency, yield, and product quality while reducing costs.
- Utilize Lean Manufacturing, Six Sigma, and other problem-solving methodologies to identify root causes and implement corrective actions.
- Implement automation and control strategies to enhance process capability and reduce variability.
- Project Management:
- Lead and manage multiple engineering projects simultaneously, ensuring on-time and within-budget completion.
- Prepare and present technical reports, project updates, and process performance metrics to senior management.
- Compliance & Quality:
- Ensure processes comply with regulatory requirements (e.g., FDA, OTC monographs) and internal quality standards.
- Support quality assurance initiatives by conducting risk assessments, participating in audits, and implementing corrective actions as necessary.
- Equipment & Facility Support:
- Provide engineering support for the selection, installation, and qualification of manufacturing equipment.
- Oversee the development and maintenance of process control systems and work with the maintenance team to ensure optimal equipment performance.
Qualifications
- Bachelor’s Degree in Chemical Engineering, Mechanical Engineering, or a related field. Master’s Degree preferred.
- Minimum of 7+ years of experience in process engineering, with at least 3 years in personal care, skincare, or OTC manufacturing.
- Expertise in formulation and manufacturing of sunscreens and skincare products is highly desirable.
- Strong knowledge of cGMP, FDA regulations, and OTC compliance standards.
- Demonstrated experience in process scale-up, equipment selection, and process troubleshooting.
- Lean Six Sigma certification (Green Belt or higher) is a plus.
Skills & Competencies
- Excellent problem-solving and analytical skills with a strong attention to detail.
- Strong project management and organizational skills, with the ability to manage multiple priorities.
- Effective communication and interpersonal skills for cross-functional collaboration.
- Ability to work independently as well as in a team-oriented environment.
