Grifols Shared Services North America, Inc Validation Specialist - Automation (Large Scale Capital Projects) in Clayton, North Carolina

Grifols is a global healthcare company whose mission is to improve the health and well-being of people. Our three divisions –Bioscience, Diagnostic and Hospital–develop, produce and market our innovative products and services to medical professionals in more than 100 countries.

We are committed to fostering an environment that creates continuous learning opportunities and encourages professional development and growth. As a company devoted to improving the health and well-being of people, we are looking for talented professionals worldwide. Make a difference and join us in this challenging and rewarding enterprise.

The Validation Specialist will lead and support automation qualification activities throughout the site on multiple automation platforms including PLC’s, DeltaV Distributed Control Systems, Andover Building Automation Systems, and other automation platforms as implemented on site. Qualification of automation includes all areas of the manufacturing operations, site GMP utilities, and support of capital projects. This position is responsible for assigned qualification and validation related activities related to supporting the Clayton NC site.

Responsibilities include:

  • Actively manages and completes all phases of assigned automation 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 on above referenced automation platforms based on approved design specification documentation.

  • 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 (ER’s and CAPAs).

  • Reviews engineering drawings and design documents (P&IDs, FRS’s, 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.

  • Actively manage automation validation resources for large scope projects are assigned.

  • Mentor junior level validation specialist on automation system qualification of platforms referenced above.

Requirements:

Specialist II - Requires a BS/BA degree in Engineering or a scientific discipline.

Requires 5 years of related experience in the automation validation field.

An equivalent combination of education and experience may be considered.

Senior Specialist I - B.S. in Life Sciences, Chemistry or Engineering plus 5 years experience in Automation Validation is 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 plus 7 years experience in Automation Validation.

A technical background encompassing engineering and instrumentation controlled by PLC’s and Distributed Control Systems.

Familiarity with plasma fractionation and purification, aseptic processing, filling, sterilization, GMP regulations, and Quality Operations are desirable.

Must have direct experience of the functional operation and validation of PLC’s and Delta-V Distributed Control Systems. Additional experience with Andover Building Automation Systems a plus. Knowledge 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, processing vessels, Particle Monitoring Systems, and Sterile Filling Operations are desired.

An equivalent combination of education and experience may be considered.

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.

EEO/Minorities/Females/Veterans/Disability

Location: [[mfield6]] : [[cust_building]]

Learn more about Grifols at http://www.grifols.com/es/web/international/home

Req ID: 70060

Type: Regular Full-Time

Job Category: Manufacturing