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Utilities Technical/Sr. Technical Production Specialist

4 months ago

NCClayton, United States GRIFOLS, S.A. Full time

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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.

The Technical/Sr. Technical Production Specialist is responsible for designing, developing, implementing, conducting, monitoring and/or evaluating new and existing manufacturing equipment and processes.  Support projects related to technical, cGMP, safety or administrative needs.  Provides support after-hours for complex technical troubleshooting.

 

Responsibilities:

  • May supervise a small group of employees
  • Independently investigate complex incidents.
  • Advance technical project proposal to Senior Management, following through to successful completion.
  • Responsible for allocation of resources at division/department level for projects and incident resolution.
  • Provide input for budget forecasting for production scheduling operations.
  • Serve as an SME for manufacturing processes, equipment, workflow, documents and projects for the BU, peer BU and partner groups.
  • Other duties and responsibilities as assigned

 

Additional Responsibilities:

  • Chairs BU meetings
  • Provides documentation and memos to incident investigation group upon request
  • Creates document red lines for projects, periodic reviews, CAPAs, general improvements
    • SOPs
    • Qualifications
  • Performs and documents operator training
    • Qualifications
  • SAP SME
    • Material transfers (SDA-3A)
    • 900404 PO REQ entry & goods receipt
  • Manages SDA-3A/crude usage, volumes, and deliveries
  • Completes SDA-3A monthly and annual reports
  • Weekly Packet SME
    • Monitors and reconciles necessary corrections
    • Files Weekly Packets with Central Records
  • Monitors, documents, and disseminates monthly Utility OPs metrics
    • Training
    • Environmental reporting/monitoring
    • MOCs/CCRs statuses
  • QMR slides for GT Maintenance/Engineering
  • Operations Work Scheduling and Planning
    • UTIL-OPS Preventive Mainteance Work Orders
    • UTIL-OPS Corrective Work Orders  
    • Pre-Treatment Maintenance
      • MMF/Softener/Carbon/RO/EDI - Backwashes/Regenerations/Cleanings

 

Requirements:

Technical Production Specialist II

  • BS/BA degree and 5 years of related experience.  An equivalent combination of education and experience may be considered.  In addition must be a SME in 4 Unit Operations and 2 functions or 2 departments.
  • Unit Operations are defined as:  Aseptic Processing, Filtration, Chromatography, Centrifugation, Lyophilization, Packaging/Labeling, Cleaning, Sterilization, Mixing, Laboratory Technique, Plant Utilities, GMP Utilities, Formulation, and Viral Inactivation.
  • Functions are defined as:  Investigations, Documentation, Projects, Technical Support, SAP/Bioman, CIP, Compliance, and Scheduling.
  • Departments are defined as:  Manufacturing departments.

 

Sr. Technical Production Specialist

  • BS/BA degree and 6 years of related experience.  An equivalent combination of education and experience may be considered.  In addition must be a SME in 6 Unit Operations and 3 functions or 3 departments.
  • Unit Operations are defined as:  Aseptic Processing, Filtration, Chromatography, Centrifugation, Lyophilization, Packaging/Labeling, Cleaning, Sterilization, Mixing, Laboratory Technique, Plant Utilities, GMP Utilities, Formulation, and Viral Inactivation.
  • Functions are defined as:  Investigations, Documentation, Projects, Technical Support, SAP/Bioman, CIP, Compliance, and Scheduling.
  • Departments are defined as:  Manufacturing departments.

 

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.

 

Occupational Demands:

Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists.   Occasionally walks and stands. Occasionally bends and twists neck.  Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Frequently drives to site locations with occasional travel within the United States. Able to communicate 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.  Interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues.

 

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 

 

Learn more about Grifols