Senior BioProcess Operations Technician

Job Description

Position Overview:

The Senior BioProcess Operations Technician will be a member of the Maintenance & Operations team within the Vaccines integrated process team for a start-up vaccine manufacturing facility in Wilson, NC.  This person operates and assists coaches with managing final packaging & inspection equipment as part of an empowered work team. This position carries out our mission by assuring finished goods and services are of the highest quality, optimal cost, and delivered on schedule.  The Senior Operations Technician routinely performs and leads line-specific duties including line check-in, batch management, in-process quality monitoring, equipment operation, work center cleaning, change-over and material movement with a high degree of accuracy and efficiency in accordance with established procedures.  In addition to leading operations activities, the role will be accountable for enforcing EHS and GMP compliance within their area of assignment. This position will be an individual contributor and a lead member of the Operations team.

Primary Responsibilities

• Function as a role model in our team-based Employee Involvement culture, focusing on the effectiveness of operations and implementation of viable continuous improvement initiatives

• Assists with the coordination of daily work schedules and effectively communicates daily customer service and performance targets

• Assist coaches and operators with operational, mechanical, and technical activities that support our production standards, while enforcing GMPs and SOP adherence

• Leads the charge to ensure standard work areas are in a constant state of compliance with respect to proper housekeeping, material segregation, and personal gowning, including required protective equipment

• Team leader and trainer in the set up and adjust of production equipment, including single use mixer, filling, high-voltage leak detectors, labelers, cartoners, printers and other assemblies, as needed for optimal performance within qualified parameters 

• Assists in the development of training documents and procedures and provides training to ensure team members are qualified and proficient in production equipment and processes

• Manages areas to ensure the maintenance of detailed records as it relates to equipment cleaning, set-up, and challenge documentation

• Assists with managing the accuracy of critical information, and ensures the completion of required documentation for production processes to ensure optimal line performance

• Assists coaches to ensures operational concerns are visible and solutions and/or continuous improvement actions are taken with an appropriate sense of urgency for appropriate resolution

• Resolves and reports issues with product accountability and SAP system problems

• Demonstrates a mechanical aptitude with the ability to troubleshoot equipment and process related occurrences

• Responsible for problem solving and process improvement initiatives

• Assists management with completing Tier 1 actions; escalates concerns to the Tier 2 process

• Supports off-shifts and weekend work as required for this position

Quality

• Interacts with other departments to ensure all packaging operations are performed in accordance with current Good Manufacturing Practices (cGMP), site Standard Operating Procedures (SOPs) and Divisional policies and guidelines

• Works with Quality, Maintenance, and Planning to identify and resolve quality issues/deviations; supports all investigations and corrective actions

• Examine products to detect defects, product damage, or other visual quality problems

• Troubleshoot and offer resolution and recommendation to coaches; appropriately gather and provide information for corrective actions

• Provides guidance to others with documentation actions in the SAP PI sheets and paper records. Interacts with MMS (Materials Management Specialists) personnel to resolve component issues, including incoming quality concerns

Safety

• Conforms to established safety procedures in accordance with OSHA and other regulatory agencies

• Recognizes, utilize, and enforces the use of safety equipment when/as needed

• Champion for and actively takes accountability for personal safety as well as the safety of others

• Identifies, reports, and documents unsafe acts/conditions, participates in the investigation of accidents/injuries/incidents and in developing corrective and preventative actions (CAPA)

Equipment