Technical Production Specialist I/II (NFB)

Technical Production Specialist I/II (NFB)

Location: NC-Clayton, US

Contract Type: Regular Full-Time

Area: Manufacturing

Schedule: Monday to Friday - 8 AM-5PM

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

Primary responsibilities for role:

• Schedule activities (i.e. fill, bulk, column run) to meet production schedule.
• Schedule materials (i.e. chemical filters) to support production run.
• Develop weekly production schedule per budget forecast.
• May consult other BUs (i.e. Engineering, Validation) regarding manufacturing concerns, conduct incident investigations and determine and implement corrective and preventive action.
• Identifies patterns or trends within the organization and participates in training needs assessments to develop recommendations for training interventions.
• May participate on startup and validation support projects.
• Contribute to investigation of simple incidents.
• Provides support after-hours for simple technical troubleshooting issues.

Technical Production Specialist II Primary responsibilities for role:

• Must be able to perform all responsibilities described in the Technical Production Specialist job description.
• Direct a small group of employees work/activities.
• Independently investigate simple incidents or contribute to investigation of greater complexity.
• Participate/schedule non-routine activities to avoid impact to the production schedule (i.e. media, validation runs, non-routine sampling support, column packaging/reslurry, UF cassette change out, etc.)
• Participate in non-routine activities to evaluate CAPAS for type (1) incidents
• Identifies patterns or trends within the process and participates in evaluating potential process/equipment changes in response.

Sr. Technical Production Specialist Primary responsibilities for role:

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

Education & Experience: Technical Production Specialist:

• BS/BA degree in a relevant field and 4 years of related experience or an equivalent combination of education and experience may be considered.
• In addition, he/she must be knowledgeable in 2-4 Unit Operations and 1-2 functions or 1-2 departments.

Technical Production Specialist II:

• BS/BA degree in a relevant field and 6 years of related experience or an equivalent combination of education and experience may be considered.
• In addition, he/she must be a SME in 4 Unit Operations and 2 functions or 2 departments.

Sr. Technical Production Specialist:

• BS/BA degree in a relevant field and 7 years of related experience or an equivalent combination of education and experience may be considered.
• In addition, he/she 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.

Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws.