Sr. Test Engineer

CSafe is seeking a Senior Test Engineer at our World Headquarters, in Monroe, Ohio to join our world class global engineering team! You will be responsible for the planning, overseeing, and documentation for the development and qualification testing of temperature-controlled packaging systems for the US and LATAM regions. You will be reporting directly to the Technical Qualification Manager.

CSafe offers the most comprehensive suite of thermal shipping solutions for pharmaceutical cold chain shipping needs around the world to ensure patients receive the medicines and treatments they need. In addition to key acquisitions, CSafe has operations in more than 70 locations worldwide to ensure product availability and continue to fulfil our founders mission to provide patients around the world with access to viable, life-enhancing pharmaceuticals. With a client-first focus, deep industry expertise and commitment to innovation, CSafe continues to deliver industry-leading products provides an end-to-end portfolio including active and passive bulk air cargo, parcel, cell and gene and specialty last-mile use cases. Our team operates with curiosity, humility, accountability, and entrepreneurial spirit to deliver on our vision and mission.

Come join our growing industry and build your career with us!

Key Responsibilities:

• Lead the development of quality documentation to facilitate qualification of temperature-controlled packaging including Design Qualification (DQ), Operational Qualification (OQ) and Performance Qualification (PQ) testing protocols, reports, test plans and procedures to meet customer and industry validation requirements.
• Review Qualification documentation for accuracy and compliance to internal standards
• Plan test schedules and support the Test Engineers during test campaigns.
• Advise customers on the appropriate materials and test samples required for thermal and distribution qualification testing. Customers communicate in Spanish and English.
• Compile and review test data upon completion of testing and performs technical analysis.
• Draft and compile technical content, data and graphics for inclusion in the qualification test report, packaging instructions and conditioning studies.
• Provide feedback and updates to the engineering and technical stakeholders to include test status, results and updates throughout the testing and evaluations process.
• Provide verbal and written project status updates on testing schedules, progress and results to the engineering and technical stakeholders.
• Ensure the technical and laboratory workplace is maintained to a high level of organization, cleanliness and order using a 5S Methodology .
• Support the maintenance of the laboratory operation SOP/WI, industry approvals, and equipment calibration and ISTA Certification.
• Select, validate, plan, and oversee external testing services at approved third party test laboratories for distribution testing and thermal testing when required.
• Perform thermal calculations, analysis and computer simulation of packaging products and cooling media would be an advantage.

Job Qualifications:

• Bachelor s degree in mechanical, thermal or packaging engineering or equivalent.
• 5+ years experience in a testing environment.
• Strong interpersonal communication skills, both written and verbal in both English. Bilingual in Spanish preferred.
• Ability to create, read and understand test standards and test protocols.
• Knowledge of Microsoft 365 suite of programs. Must be proficient user of Microsoft Word & Excel.
• Familiarity with CAD software (SolidWorks) and testing guidelines (ISTA, ASTM, IATA) a plus.
• Organizational skills; able to meet deadlines.
• Must possess analytical thinking and reasoning skills.
• Experience in training technical processes to others.
• Must be self-motivated, self-managed.
• Must be thorough and exercise attention to detail.
• Must be a team player.

Our Benefits Include:

• Paid Time OFF (PTO) starting at 25 days & Paid Holidays
• Medical, Dental and Vision Insurance
• 401k with Employer Match
• Group Life & Disability
• Health Spending Account Options
• Identity Protection
• Employee Assistance Program
• Travel Assistance Program
• Financial Wellness Program
• Tuition Reimbursement
• Parental Leave
• Referral Program
• Gym Membership Reimbursement
• Hybrid Work Options working four days in the office and one day from home.

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.