Senior BioProcess Operations Technician

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 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

• Operates and trains others to use packaging & inspection equipment within qualified parameters; performs and documents equipment challenges per current procedures.

• Demonstrates mechanical ability to troubleshoot problem solve and train others to recognize and solve equipment concerns as it relates to product jams and component problems

• Identifies and effectively communicates equipment problems to assist maintenance technicians with troubleshooting and corrective repairs

Financial

• Contribute to achieving departmental financial goals by understanding communicating and controlling labor costs component usage and material waste.

• Works with the coach to determine root cause for line downtime that causes misses for SA (Schedule Adherence) and delivery

Team Individual Performance

• Actively assist coaches in leading a team-based culture through team meetings and continuous improvement activities

• Demonstrates a high degree of maturity leadership and personal integrity

• Strictly adheres to all site policies on personal conduct and attendance

• Collaborates and communications with peers and other employees at various levels throughout the organization; demonstrates leadership and conflict-resolution ability

• Demonstrates a willingness to provide and receive constructive feedback in 360 performance review

Reporting Relationships:

• Solid line report to: Manager Maintenance & Operations

• Dotted line report to: N/A

• Position(s) reporting to this position: N/A (individual contributor)

Work Schedule:

• 8-hours 3rd shift

Minimum Education Requirement

• High School diploma or equivalent

Required Experience and Skills

• Three or more years of experience in a GMP manufacturing facility (aseptic GMP environment strongly preferred)

• Demonstrated proactive leadership ability peer training experience and productivity improvement activity involvement

• Demonstrated organizational and interpersonal skills with ability to influence and support others through a culture of inclusion feedback and empowerment

• Must have excellent verbal and written communication skills

• Ability to gown and work in an aseptic environment

• Demonstrated ability to work with computerized and automated systems.

• Willing to work irregular hours to support multi-shift operation on an as needed basis

Preferred Experience and Skills

• Associates degree in business Science or Technology-based field and/or bio-pharma focused certificates such as Bio-works preferred.

• Yellow Belt certified or Kata training

• Experience with aseptic filling visual inspection systems CIP/SIP systems packaging equipment and similar aseptic formulation and filling operations

• Experience operating maintaining troubleshooting and/or repairing industrial equipment

• Experience working in a regulated environment (FDA etc.) and basic knowledge of cGMPs as they apply to the vaccine/pharmaceutical industry

• Experience in Continuous Improvement Lean Manufacturing Problem Solving and/or Right First-Time methodologies

• SAP / MES / electronic logbook basic knowledge from a production execution perspective

• Outstanding communication skills both within direct team and across multiple shifts to ensure success of overall team

• Effective and efficient computer skills with experience using SAP

• Ability to support technical writing of documents such as standard operating procedures (SOPs) and work instructions (Wis)

#MSJR

VETJOBS