The incumbent will be supporting the following activities to ensure conformance with ISO 11607 for all SKU’s packaged at Integra Añasco. • Data Gathering – Participate in the discovery and compilation of required documentation to be evaluated. • Document Generation – Generate all documentation required, included but not limited to Change Control, Validation Protocols, Drawings, Routers, etc identified as required as part of the project needs. • Validation Executions – Participate in the validation activities (IQ, OQ, PQ, Shipping and Shelf Life, TMV etc.) required to ensure compliance with ISO 11607 as part of the project deliverables. The incumbent will be working with cross functional areas on activities described above. Responsible for the delivery of tasks to ensure conformance to the project plan schedule. Knowledge, skills, and abilities: • Must have knowledge of ISO 11607 regulations for sterile barrier packaging. • Must have a thorough understanding of packaging and transit (transport) testing and performance test methods (conditioning, compression testing, drop testing, vibration testing, bubble leak test, among others). • Must have knowledge in shelf-life validation (aging studies), sterile barrier sealing process validation and packaging validation. • Must have knowledge and working experience in package and sealing integrity tests as well as package seal strength tests such as: seal strength (peel) test, burst test, creep test, bubble leak test and dye penetration, among others. • Must have a solid understanding of packaging materials, capabilities, and equipment. • Knowledge of FDA, OSHA, EPA, and GMP’s and ISO requirements. • Proficiency in usage of Minitab and equivalent tools to perform advanced statistical analysis. • Able to develop technical documentation such as: Change Controls, Validation Plans, Validation Protocols, Technical / investigation reports, SOP, and others. • Must have excellent communication skills and a strong track record of working cross-functionally. • Ability to assess technical issues and develop solutions utilizing an analytical approach to problem solving. • Teamwork oriented and self-starter.

Requirements:

• Fully bilingual (English and Spanish). • Availability to work extended hours in a day and weekends as required. Education and/or experience: • BS in Science or Engineering, preferably Mechanical, Industrial, Electrical, Chemical, or Biomedical. • Hands-on experience with ISO11607 remediation projects, compliance projects, process validation and/or packaging validation projects required. • Experience with managing documents within electronic PLM system. • Experience with working with cross functional team. • Minimum of 5 – 7 years of experience in the medical device and/or pharmaceutical manufacturing environment; with at least five (5) years in manufacturing process, quality or validation engineering position and preferably with exposure to Packaging Validations, Design Control and Product/Process Transfer.

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