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 Validation Specialist 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:

• 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.

 

Requirements

 

Education and Experience based on level:

 

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

 

Knowledge, Skills, and Abilities:

• 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 validation of at least 2 of the following: Utilities (HVAC, WFI, clean steam, compressed process air and nitrogen), Filtration (Sterile, depth, filter presses), Purification (chromatography, ultrafiltration, nanofiltration), steam sterilization, Clean-In-Place systems and processing vessels.  

 

Sr. Validation Specialist I:

The Sr. Validation Specialist I is responsible for conducting validation studies in accordance with current industry standards and guidelines for the qualification and validation of manufacturing systems and supporting processes.   Perform validation studies in support of various projects of High complexity.   Performs qualification / requalification activities, such as, Equipment, HVAC, Clean Steam, Cleaning, APR, CPV.  Evaluate and analyze validation data related to the project as well as coordinate validation activities. SME in high complexity / large capital project validation-experience conducting va