Provides advanced operational and process knowledge within the team by operating equipment, allocating resources, training fellow-Technicians, and communicating production status across shifts to ensure compliance with cGMP, FDA, DEA, OSHA and other applicable regulations. Leads and ensures active participation in Performance Center (PC) meetings driving to continuous improvements.
Routinely sets up, operates, and cleans equipment to standard.
Directly completes batch documentation and reviews documentation completed by others, both written and electronic, for accuracy and ensures it is complete as required by policies, procedures, and regulatory guidelines.
Ensure the disassembly and cleaning processes are executed to standard, through inspection, and meets documented cleaning requirements.
Identifies safety hazards, through leadership and engagement, within the work area / resource.
Ensure safety related risks are identified, corrected, and/or escalated through the AOP process.
Utilizes the near miss reporting process to bring visibility and corrective actions to work place hazards.
Models the safety mind-set within the team through strict adherence to policy and work place standards.
Focus: Quality and Compliance
Ensures line of sight and 5S activities are sustained trough the AOP process.
Through leadership and engagement within the team, ensures all materials used are approved and properly documented in batch records and ERP systems.
Actively participates in quality / compliance discussions (RRRFT Process) driving for root cause and robust corrective actions.
Actively drives DEA compliance within the team and is the area subject matter expert on DEA processes and procedures.
Ensures PM completion and compliance for area operations, utilizing the PC discussions to track and monitor performance.
Focus: Execution Excellence
Maintains Performance Boards in support of visual factory management and a strategy of operational consistency and standardization.
Through PC discussions, monitors and communicates area / resource performance (i.e. safety, quality, run standards, change over standards, etc.).
Utilizes PCs to escalate issues / concerns, identify opportunities for improvement, and develop next steps.
Overcomes or escalates obstacles preventing the area / resource from executing to standard.
Champions the CIA process for the area / resource ensuring timely assessment, discussion, and status of actions.
Trains others on equipment, GMPs, and business processes within area of responsibility.
Acts as a Training Subject Matter Expert (TSMET) in the training process.
Educates fellow Technicians when errors occur and escalates to Certified Coaches if errors impact safety, quality, or performance to standard.
Provides input, serves as the subject matter expert for the area, and updates procedures or training modules as needed.
Maintains qualification and proficiency on equipment set up, operations, and cleaning.
Leads the PC discussions at the beginning and end of shifts, ensure robust communication between shifts.
Models individual behavior through operating, setting up, cleaning and documentation, to support adherence to safety, quality, and operational performance standards.
Works with Coaches to support the resolution of interpersonal conflicts within the team that negatively impact its performance.
Works cross functionally and collaborates with support groups (Engineering, Quality, etc.) to resolve issues.
Attains and maintains Super-User access in electronic systems (E-Forms, SAP, PMX, EBR) applicable to area of responsibility to support production. Leverages this expertise to resolve obstacles and improve quality and efficiency.
Demonstrated success in the pharmaceutical manufacturing and/or packaging industry.
Demonstrated understanding of pharmaceutical production equipment and processes within area of responsibility with a strong preference for being fully qualified on the equipment within the area of responsibility.
Ability to attain and maintain qualification status on equipment within area of responsibility.
Ability to attain and maintain certification status for Certified Cleaner and Certified Inspector programs.
Demonstrated ability and willingness to work and participate effectively in a team environment.
Ability to attain and maintain certification status as a Training Subject Matter Expert (TSMET).
Demonstrated ability and willingness to maintain accurate and factual records.
Demonstrated ability to use computers to perform a variety of data-entry transactions and to retrieve information (procedures; safety, employment, and other information). Must be able to use MS Office products (specifically Word, Outlook, and Excel), and perform data entry/maintenance in SAP or equivalent systems.
Ability to attain and maintain super-user status on critical computer systems relevant to area of responsibility (SAP, EBR, eForms, etc.)
Demonstrated attention to detail and must be safety, quality and customer focused.
Must possess basic Math skills which include the ability to set up and solve problems involving more than one math operation (addition, subtraction, multiplication, division) on whole numbers, fractions, decimals, or percentages. Must also be able to calculate conversions using a calculator or other device as well as working knowledge of the Metric System.
Ability to use measuring devices.
Ability to effectively solve problems within area of responsibility using sound judgment and manage time.
Requires mechanical and technical aptitude as demonstrated via successful completion of training modules on equipment within, or similar to, their area of responsibility.
Demonstrated ability to communicate effectively, both verbally and in writing, with personnel at all levels, both internal and external to the organization.
Ability to read information and apply what was described in the reading material to situations which may contain several details or describe processes involving several steps.
Strong interpersonal effectiveness and leadership skills. High level of personal motivation and initiative.
Become knowledgeable of all DPs, SOPs, and regulatory requirements.
Must be adaptable and flexible.
Ability to meet the physical requirements (pushing, pulling, lifting, etc.) of the technician role.
Experience in a manufacturing environment including documentation, set-up, operation, cleaning and basic maintenance of manufacturing equipment.
Pharmaceutical or other regulatory experience.