Senior Process Engineer I - VS Collagen/LYO

Senior Process Engineer role focused on optimizing manufacturing processes for collagen and lyophilization products. Responsible for process development, validation, continuous improvement, and cross-functional project leadership while ensuring regulatory compliance and operational efficiency.

Responsibilities

• Develop and implement engineering studies, validations, and process specifications aligned with GMP and regulatory requirements
• Lead cross-functional projects to identify and execute process, quality, and cost improvements using lean six-sigma methodologies
• Perform technical investigations, failure analysis (FMEA), and corrective/preventive actions (CAPA)
• Monitor and trend process parameters using statistical tools to improve yields and reduce manufacturing scrap
• Manage bills of materials, routings, and work instructions; develop training programs for manufacturing teams

Requirements

• Bachelor's degree in engineering or equivalent with 5+ years experience; Master's degree with 3+ years experience
• Statistical process control expertise (SPC, Minitab or similar software)
• Lean Six Sigma certification or demonstrated experience
• 4+ years managing validation cycles (FAT, IQ, OQ, PQ, TMV) and engineering documentation
• Experience leading multi-functional teams across EHS, quality, process development, planning, and materials
• Technical investigation, non-conformance, and CAPA execution experience
• Bilingual proficiency in Spanish and English preferred

Compensation: $51,000–$71,000 USD base salary