Sr Engineer f amiliar with distribution testing per ASTM D4169, International Organization for Standardization (ISO), Technical Association of the Pulp and Paper Industry (TAPPI), United States Pharmacopoeia (USP), and European Pharmacopoeia (EP). Skills: Strong knowledge of primary and secondary packaging systems and material science (common materials used in healthcare packaging). Material knowledge of structural components is integral in the day-to-day oversight of this role: labels, trays, lidding material, leaflets, paperboard, sterile barrier packaging, corrugate, etc. Experience building, modifying, and approving engineering drawings using AutoCAD, Adobe Illustrator, Solid Works, or similar software applications. Strong organizational, project management, technical problem-solving, and communication (written and verbal) skills. Ability to work in teams and adapt to continuously evolving environments. Excellent understanding of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP). Ability to work independently with demonstrated skills in leading project teams. Experience writing test protocols, performing technical evaluations and testing to support reports used to uphold the use of selected materials and packaging components. Requirements Doctorate or Master's Degree or Bachelors Degree in Mechanical Engineering Seven years of final product manufacturing experience with 4+ years within the Pharma/Biotech Industry Fully Bilingual (English/Spanish) Familiar with distribution testing per ASTM D4169, International Organization for Standardization (ISO), Technical Association of the Pulp and Paper Industry (TAPPI), United States Pharmacopoeia (USP), and European Pharmacopoeia (EP). Technical writing

QRC group is a life science firm dedicated to provide services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields.
Our services and solutions include:
Process and Laboratory Investigation
• Corrective and Preventive Action (CAPA)
• Change Control
• Training
• Document Management Control
• QA Laboratory
• Methodology Transfer and Validation
• Instrument Calibration
• Validation and Training in Chromatographic Data Acquisition System
• Cleaning Validation
• Automation Engineering
• Quality Systems