Engineer - Validation I/II / Validation Specialist I/II / Sr. Validation Specialist I

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

 

 

Overview:
The Engineer I - Validation / Engineer II – Validation / Validation Specialist I  / Validation Specialist II / Sr. Validation Specialist I position supports Fractionation, Purification, Filling, Utilities and/or capital projects as required. This position is responsible for assigned qualification and validation related activities related to supporting the Clayton NC site.  

  
Primary responsibilities for role include but are not limited to the following:
• Actively manages and completes all phases of assigned equipment, facilities, utilities and process qualification and validation activities.  
• Facilitates cross functional problem-solving involving Quality Operations, Regulatory Affairs, Engineering and Manufacturing. 
• Makes independent decisions within defined areas of responsibility. 
• Write protocols, reports and validation master plans and assembles final validation report packets as required to meet qualification/validation objectives. 
• Authors, reviews, and executes qualification and validation documents within a defined Quality system. 
• Schedule and perform qualification and validation studies to meet timelines. 
• Evaluate and analyze qualification/validation data collected, while verifying acceptability of the data and compliance with the protocol. 
• Conducts discrepancy investigations and identifies and implements effective root cause corrective actions (CAPAs). 
• Reviews engineering drawings (P&IDs, construction, as-built, flow diagrams) for compliance to GMP/Validation principles and provides feedback to project team for any noted deficiencies or improvements. 
• Participates in meetings as the validation representative for assigned projects involving project planning, scope development, design, construction, startup, qualification, validation and administration. 
• Interacts regularly with project team members and influences overall scope development and communicates with all levels of employees within and outside the team. 
• Reviews qualification/validation turn-over packages for completeness and accuracy, compliance with policies and procedures and accurate data analysis. 
• Prepare, program, maintain and use various data acquisition systems including Kaye Validators and Kaye Valprobes.  
• Use other test equipment such as tachometers, thermometers, hygrometers and differential pressure monitoring devices as required for qualification protocols.
 
Skills/Qualifications/Education Requirements:  (To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, education, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions)
 
Specialist I - Requires a BS/BA degree in STEM (Science, Technology, Engineering, and Mathematics). An equivalent combination of education and experience may be considered.  The job requires a minimum of 2 years' experience in the pharmaceutical industry

Specialist II - Requires a BS/BA degree in STEM (Science, Technology, Engineering, and Mathematics). An equivalent combination of education and experience may be considered.  The job requires a minimum of 4 years' experience in the pharmaceutical industry

 

Engineer I - Validation -  Requires Bachelors Degree in Engineering. The job requires a minimum of 0-2 years experience

Engineer II - Validation -  Requires Bachelors Degree in Engineering. The job requires a minimum of 2-4 years experience which can include Co-Op or internship

 

Sr. Specialist I - Validation - Requires a BS/BA degree in STEM (Science, Technology, Engineering, and Mathematics). An equivalent combination of education and experience may be considered.  The job requires a minimum of 6 years' experience in the pharmaceutical industry

• A technical background encompassing engineering, instrumentation, biology, chemistry, microbiology, statistics, and thermodynamics is desirable.  
• Familiarity with plasma fractionation and purification, aseptic processing, filling, sterilization, GMP regulations, and Quality Operations are desirable.  • Must have knowledge of the principles of equipment design/operation and validatio