Grifols Shared Services North America, Inc Validation Specialist I/II Sr. I/II in Clayton, North Carolina
Validation Specialist I / II / Sr I/ Sr II
Validation Specialist position to support 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.
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.
Specialist I - Requires a BS/BA degree in Engineering or a scientific discipline. Requires minimum 3 years' experience in the pharmaceutical industry. An equivalent combination of education and experience may be considered.
Specialist II - Requires a BS/BA degree in Engineering or a scientific discipline. Requires 5 years of related experience in the validation field. An equivalent combination of education and experience may be considered.
Senior Specialist I - B.S. in Life Sciences, Chemistry or Engineering. MS preferred. 5 years’ experience in Validation and/or Quality Operations required.
Experience in pharmaceutical processing and/or packaging and filling equipment (Bio-Pharmaceutical experience a must).
Knowledge of FDA cGMP’s, Regulatory Compliance, Standard Operating Procedures, QA/QC documentation, and GXP’s as required, the ability to interpret engineering documentation a must.
Successful Manufacturing, Quality System or Validation track record required.
Track record of producing high quality work according to schedules and timelines.
An equivalent combination of education and experience may be considered.
Senior Specialist II - Bachelor's degree in Engineering or a scientific discipline. Minimum 7 years’ experience in Validation. An equivalent combination of education and experience may be considered.
Knowledge, abilities & skills:
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.
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. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Occasionally walks. Repetitive 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.
Req ID: 168807