Lead Technician, Physical Flow, 3rd Shift (S-TH, 11p-730a)

Job Title: Lead Technician, Physical Flow

Location: Columbus, OH

Job Type: Full-Time

Req ID: 4334

 

 

About Us:

As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates’ mission is to bring Better Health. Within Reach. Every Day.® for millions of patients around the world.  We are a trusted, reliable partner and dependable source of over 750 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe.  Through our 32 manufacturing plants, eight R&D centers, and 8,500+ employees worldwide, we are always hard at work creating high-quality medicines and making them accessible to the people who need them.

 

Description:

We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds.  We are seeking a talented and motivated Lead Technician, Physical Flow to join our team. 

 

In this role, you will be responsible to provide advanced operational and process knowledge within the team by operating equipment, allocating resources, training and/or mentoring fellow technicians, and communicating production status across shifts to ensure compliance with cGMP, FDA, DEA, OSHA and other applicable regulations. Lead and ensure active participation in Performance Center (PC) meetings driving to continuous improvements. Actively oversee and monitors line/area performance in relation to Key Performance Indicators (KPIs).

 

Identify safety hazards, influence corrective actions, or escalates risks, and model the safety mind-set within their teams.  Manufacture and/or package product in accordance with policies, procedures and regulatory guidelines and ensures documentation, both written and electronic, is accurate, complete, and factual.  Set-up and operates equipment within Flow area of responsibility and ensures it is operating correctly.  Ensure all materials, product, equipment is correct and approved for use.  Ensure that quality is built into production processes and uses the Quality E-Stop by halting production when a quality concern is identified or suspected.  Elevate issues that occur to address idle time.  Identify continuous improvement activities (CIA) and assist with the implementation.

 

Key Responsibilities:

• Regular and predictable onsite attendance and punctuality.
• Maintains qualifications and proficiency on equipment set up, operations, and cleaning.
• 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.
• Able to assess atypical situations, reference appropriate Work Instructions (WI) and SOPs to determine root cause, escalates issues to Supervisor and Quality. Helps determine corrective actions.
• Identifies safety hazards, through leadership and engagement, within the work area / resource.
• Ensures safety related risks are identified, corrected, and/or escalated through the Area Ownership Program (AOP) process.
• Utilizes the near miss reporting process to bring visibility and corrective actions to workplace hazards.
• Models the safety mind-set within the team through strict adherence to policy and workplace standards.
• Participates in safety audits.
• 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 Enterprise Resource Planning (ERP) systems, i.e, Electronic Batch Records (EBR), PMX, SAP, etc.
• 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.
• Partners with Maintenance / PRT / Supervisor to assist in scheduling and completion of Preventive Maintenance (PMs) items.
• 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, Set-Up/Run/Clean standards, change over standards, Overall Equipment Effectiveness (OEE), Zero Defect rate, Sequence Adherence). Reviews and submits Shift Summary Reports.
• Util