Validation Specialist Validation Engineer I II 526665
Validation Specialist Validation Engineer I II 526665
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1 Vacancy
Job Description
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 wellbeing of people around the world. We are leaders in plasmaderived 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 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 problemsolving 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 asbuilt 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 turnover 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
Engineer I Validation Requires Bachelors Degree in Engineering. The job requires a minimum of 02 years experience
Engineer II Validation Requires Bachelors Degree in Engineering. The job requires a minimum of 24 years experience which can include CoOp or internship
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 CleanInPlace systems and processing vessels.
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 Bachelors degree plus 4 years of experience an equivalency could include 8 years of experience an Associates degree with 6 years of experience or a Masters 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 46 hours per day. May stand; bends and twists neck and waist for 24 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.
All Manufacturing Production Employees Exempt from Internal Bidding unless it results in a promotion (e.g. Tech III bids for a Supervisor or Coordinator role) Due to the growth at the GT site and ramping up multiple Manufacturing departments it is vital that we focus on training newer employees and maintaining existing area expertise while we work through this growth phase no GT Manufacturing production employees are eligible to bid for this position at this time.
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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 : NCClayton:USNC0002 Clayton
Required Experience:
Unclear Seniority
Employment Type
Full-Time
