Senior Process Engineer

Description

Position Summary:

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.

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.

Requirements

Required Skills/Abilities:

• Working knowledge or background in chemical manufacturing industry
• Strong technical and/or regulatory expertise
• Detailed record keeping and communication of results to others
• Project skills appropriate for leadership of tech transfer projects
• Excellent written, verbal and interpersonal communication skills
• High level of initiative, innovation, critical thinking and problem-solving skills
• Ability to work cross-functionally & at all levels within the organization including senior leadership
• Ability to prioritize multiple responsibilities and manage deadlines accordingly
• Communicate effectively and professionally both internally and externally
• Exceptional attention to detail and high level of accuracy & organization
• Ability to work as part of a team and excel independently in fast-paced environment
• Ability to adapt quickly to changing circumstances
• Demonstrated leadership skills
• Proficient with Microsoft Office

Required Education and Experience:

• Bachelor’s degree in Chemical Engineering, Mechanical Engineering, or a related field.
• Minimum of 7+ years of experience in process engineering, with at least 3 years in personal care, skincare, or OTC manufacturing.
• Strong knowledge of cGMP, FDA regulations, and OTC compliance standards.

Preferred Education and Experience:

• Master’s Degree preferred.
• Expertise in formulation and manufacturing of sunscreens and skincare products is highly desirable.
• Demonstrated experience in process scale-up, equipmen