Senior 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 / 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:

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

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 validation studies in accordance with current industry standards and guidelines for the qualification and validation of manufacturing systems and supporting processes desired.

Primary responsibilities for role:

• Schedule and perform validation studies to meet production and requalification, IQ, OQ, PQ, CV, and PV requirements.  This position requires giving instruction to personnel in other departments over which he/she has no direct authority. The incumbent must advise production managers and supervisors in the performance of validation activities and relate the validation schedule to production requirements. To meet the validation schedules, the incumbent must elicit help from managers, supervisors, and technicians/operators from the following departments: Manufacturing, Quality, Instrumentation, GMP, and Engineering.                                                                       

• Develops alternative solutions to problems, handles Highly complexity problems independently. Demonstrates technical knowledge and ability to adapt to changing circumstances.   The incumbent must have the interpersonal and leadership skills necessary to coordinate validation activities with managers, supervisors, and technicians/operators from production and Quality departments.  The ability to communicate effectively with staff, production, GMP, and Quality personnel at all levels is essential.  This position also requires becoming involved in resolving conflicts between production requests for process changes and the validation requirements for those processes.

• Develop qualification and validation protocols/reports for manufacturing systems, processes, and equipment such as qualification / requalification, facilities, utilities, temperature-controlled areas, cleaning, PV, APR, CPV, etc.  This position requires thorough knowledge of processes, equipment, and sterilization principles and concepts. This knowledge is used in the implementation of the "life cycle" approach to validation.

• Evaluate and analyze validation data collected during projects, verify adequacy of the information and compliance with regulations.  Performs reviewed activities in protocols.                                                         

• Direct validation related activities of production, engineering, maintenance, quality, and others.   Active member in site validation activities. Works with outside contractors, Engineers, Production, Laboratories and QA.

• Coordinates activities with laboratories, provides team leadership and assumes responsibility for entire project management.  

• Responsible for preparation, programming, maintaining, and use of data acquisition systems used for equipment and process validation.               

• Perform pre and post calibrations of thermal monitoring equipment, place probes, and generate reports and graphs of data.                                      

• Monitor use/care of and age battery life of wireless loggers                                                              

• Writes, reviews and approves validation documents for selected projects, manages and maintains schedule of validation activities. Ensures documents are signed off in a timely manner.                                                             

• Collect samples during cleaning, testing and validation, as well as generate test forms and submit samples to QC.     

• Maintain accurate, succinct and detailed documentation of activities.                                                           

• Assist with ensuring paperwork from other departments is available and complete when required.

• Actively Participates during all phases of validation evaluates projects, provides guidance and technical information to others. Supports Installation Qualification activities in Engineering, checks operating parameters during Operational Qualifications, and coordinates with testing participants (Quality, Production) during Performance Qualifications, Performance Validation and Cleaning Validation activities.   

• Reviews engineering drawings (Pipe & Instrument Designs, construction, as-built, flow diagrams) for compliance to Good Manufacturing Practices/Validation principles. Performs and reviews validation testing as required.                                                                    

• Reviews validation packets for completeness and accuracy, sound rationale, compliance with validation policies and procedures, and accurate data analysis. Compares results against acceptance criteria and brings exceptions and deviations to management's attention. Gives recommendations to management as to the acceptance and release of qualified systems.                                                                   

• SOP author qualified in revising Grifols Validation Procedures.                                                         

• Supervise validation specialist(s) and contract specialists

• Assists in validation monitoring activities which include internal/external audits with the system owner.

• Coordinates/authors the generation and organization of records, reports, and data summaries for NDA, PLA, and establishment license applications and updates.

Requirements

Education and Experience:

Sr. Validation Specialist I - Requires a BS/BA degree in related field, such as STEM (Science, Technology (i.e. Industrial Technology), Engineering, and Mathematics).  An equivalent combination of education and experience may be considered based on business need.  The job requires a minimum of 6 years’ experience in the pharmaceutical industry. SME in high complexity / large capital project validation-experience conducting validation studies in accordance with current industry standards and guidelines for the qualification and validation of manufacturing systems and supporting processes desired.

Knowledge, Skills, and Abilities:

• Knowledge of plasma fractionation, protein purification, aseptic processing and filling, sterilization, GMP regulations and Quality operations.  

• Excellent oral and written communication skills.

• Strong critical thinking and problem-solving skills.

• Ability to identify errors and provide corrective action.  

Equivalency:

Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements.  Example:  If a job level requires a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of experience. 

Work is performed in an office and a laboratory/manufacturing environment. Exposure to biological fluids with potential exposure to infectious organisms.   Exposed to occasional extreme cold below 32* and high levels of noise in production areas. Exposure to electrical office and laboratory equipment. Personal protective equipment required such as protective eyewear, garments and gloves. Frequently sits for 4-6 hours per day. May stand; bends and twists neck and waist for 2-4 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists.  Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Occasionally walks. Frequent foot movements.  Light to moderate lifting and carrying objects with a maximum lift of 50lbs. Near vision and far vision correctable in one eye to 20/30 and to 20/100 in the other eye. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences.  Performs tasks by following a set of written or oral instructions/procedures.

Recruiter - Victoria Jones

Third Party Agency and Recruiter Notice:

Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.

Grifols provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other characteristic or status protected by law. We will consider for employment all qualified Applicants in a manner consistent with the requirements of applicable state and local laws.

Location: NORTH AMERICA : USA : NC-Clayton:USNC0002 - Clayton 

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