Team Lead, Manufacturing / Production 1st/2nd/3rd Shifts

Location: Columbus, OH | Full-Time | 2nd & 3rd Shift (10% shift differential in addition to hourly rate)

About the company

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.

About the role

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 Production Lead Technician 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.

Responsibilities

• Maintain regular and predictable onsite attendance and punctuality
• Maintain qualifications and proficiency on equipment set up, operations, and cleaning
• Routinely set up, operate, and clean equipment to standard
• Directly complete batch documentation and review documentation completed by others (written and electronic) for accuracy and completeness per policies, procedures, and regulatory guidelines
• Ensure disassembly and cleaning processes are executed to standard through inspection and meet documented cleaning requirements
• Assess atypical situations, reference appropriate Work Instructions (WI) and SOPs to determine root cause, escalate issues to Supervisor and Quality, and help determine corrective actions
• Identify safety hazards through leadership and engagement within the work area/resource
• Ensure safety-related risks are identified, corrected, and/or escalated through the Area Ownership Program (AOP) process
• Utilize the near miss reporting process to bring visibility and corrective actions to workplace hazards
• Model the safety mind-set within the team through strict adherence to policy and workplace standards
• Participate in safety audits
• Ensure line of sight and 5S activities are sustained through the AOP process
• Through leadership and engagement, ensure all materials used are approved and properly documented in batch records and ERP systems (EBR, PMX, SAP, etc.)
• Actively participate in quality/compliance discussions (RRRFT Process) driving for root cause and robust corrective actions
• Actively drive DEA compliance within the team and serve as area subject matter expert on DEA processes and procedures
• Partner with Maintenance/PRT/Supervisor to assist in scheduling and completion of Preventive Maintenance (PMs) items
• Maintain Performance Boards in support of visual factory management and operational consistency/standardization
• Through PC discussions, monitor and communicate area/resource performance (safety, quality, Set-Up/Run/Clean standards, changeover standards, OEE, Zero Defect rate, Sequence Adherence)
• Review and submit Shift Summary Reports
• Utilize PCs to escalate issues/concerns, identify improvement opportunities, and develop next steps; enter or assist in entering IT tickets or maintenance requests
• Overcome or escalate obstacles preventing the area/resource from executing to standard
• Support CIA Teams and Process to provide input and/or assistance with implementation of CIAs
• Train others on equipment, GMPs, and business processes within area of responsibility
• Serve as a Training Subject Matter Expert (TSMET) in the training process
• Educate and mentor fellow Technicians when errors occur; escalate to Supervisor if errors impact safety, quality, or performance to standard
• Serve as subject matter expert for the area and provide input for updating procedures and training modules
• Support onboarding of new employees including training, mentoring, developing, and retaining
• Drive PC discussions at beginning and end of shifts, ensuring robust communication between shifts
• Display standard model behavior through operating, setting up, cleaning, and documentation to support safety, quality, and operational performance standards
• Partner with Supervisors and Management to support and monitor team culture and dynamics; work with management to resolve interpersonal conflicts negatively impacting team performance
• Work cross-functionally and collaborate with support groups (Engineering, Quality, etc.) to resolve issues
• Attain and maintain Super-User access in electronic systems (E-Forms, SAP, PMX, EBR, Overwatch, etc.) applicable to area of responsibility; leverage expertise to resolve obstacles and improve quality and efficiency
• Perform other job-related duties as assigned within scope of work

Requirements

• High school diploma or GED
• Experience in a manufacturing environment including documentation, set-up, operation, cleaning, and basic maintenance of manufacturing equipment
• Ability to perform data entry/maintenance in SAP or equivalent systems

Preferred Qualifications

• Pharmaceutical or other regulatory (cGMP) experience
• 18 months of pharmaceutical manufacturing/packaging experience

Benefits

• Annual performance bonus potential
• Hikma-sponsored 401(k) program matching 100% of the first 6% of eligible pay contributed
• Generous paid time off (PTO) bank starting with 20 days (prorated based on hire date)
• 3 personal days (prorated based on hire date)
• 11 company paid holidays
• Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits
• Employee discount program
• Wellbeing rewards program
• Safety and Quality is a top organizational priority
• Career advancement and growth opportunities
• Tuition reimbursement
• Paid maternity and parental leave

Eligibility requirements apply to some benefits and depend on job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms.