Grifols Shared Services North America, Inc Technical Production Specialist / Sr Technical Production Specialist 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 Technical Production Specialist in the Filling Department is responsible for designing, developing, implementing, conducting, monitoring and/or evaluating technical, cGMP, safety and/or administrative programs for new and existing employees; Work closely with the various department managers to support projects and all fill lines. Performs tasks in environmental monitoring, support projects, document generation and authoring, and serve as a point of contact to troubleshoot after hours call support relating to process, equipment documentation and facility issues.

Primary Responsibilities:

May consult other BUs (i.e. Engineering, Validation) regarding manufacturing concerns, conduct incident investigations and determine and implement corrective and preventive action.

May author or initial draft procedures (i.e. Batch Production Records, SOPs, etc.) regarding manufacturing process. Consult with Techs to ensure ease of read and understanding of documents, procedures, etc. Ensure correct revisions and documents are available when needed while also tracking all documents and their work flow.

Identifies patterns or trends within the organization and participates in training needs assessments to develop recommendations for training interventions.

May participate on start-up and validation support projects.

Serve as a point of contact to troubleshoot after hours call support relating to process, equipment and facility issues.

Coordinate w/other Departments for incident investigations.

Requirements:

BS/BA degree in a relevant field and 4 years of related experience. An equivalent combination of education and experience may be considered.

In addition must be a SME in 2-4 Unit Operations and 1-2 functions or 1-2 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: Clarification, Fractionation, IGIV, Purification, Filling/Packaging, Site Engineering, Technology, and Quality Operations

The Senior Technical Production Specialist assesses the department. In addition, this person performs tasks in scheduling, environmental monitoring, support projects, document generation and authoring, and serve as a point of contact to troubleshoot after hours call support relating to process, equipment documentation and facility issues

Primary responsibilities:

Must be able to perform all responsibilities described in the Technical Production Specialist job description.

May supervise a small group of employees.

Lead teams on projects, documentation, safety, etc. which may involve employees in other BU

Responsible for allocation of resources at division/department level for projects and incident resolution.

Provide input for budget forecasting for production scheduling and operations

Advances technical project proposals to Senior Management, following through to successful completion.

Independently lead type (1) incident investigations .

Serve as an SME for manufacturing process, equipment, workflow, documents, projects and training.

Requirements:

BS/BA degree in a relevant field and 6 years of related experience. An equivalent combination of education and experience may be considered.

In addition must be a SME in 5+ 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: Clarification, Fractionation, IGIV, Purification, Filling/Packaging, Site Engineering, Technology, and Quality Operations

Work is performed in a manufacturing environment with rotating shifts. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to chemicals, electrical manufacturing equipment and moving machinery. Exposure to high levels of noise and to dust/gas/fumes/steam. Exposure to extreme cold below 32*. Occasional entry into confined spaces, requiring kneeling, crawling, climbing and squatting. Works at heights on scaffolding and/or on ladders. Personal protective equipment required such as; protective eyewear, chemical suits, safety shoes and/or rubber footwear, gloves, hearing protection and a respirator. Work is performed standing, walking and bending neck for 6-8 hours per day. Frequently sits for 4-6 hours per day. Frequent 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 bends and twists neck and waist. Light lifting of 15lbs for 2-4 hours per day with a maximum lift of 50lbs. Hearing acuity essential. Color perception/discrimination, and far vision correctable in one eye to 20/30 and to 20/100 in the other eye. 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. Frequently performs routine tasks by following a set of written or oral instructions/procedures.

EEO/Minorities/Females/Disability/Veterans

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

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