Sr Associate Manufacturing - Line Lead (12hr Shift 6:00am - 6:00pm)

Role Summary

Sr Associate Manufacturing - Line Lead (12hr Shift 6:00am - 6:00pm)

Responsibilities

• Lead manufacturing operations on the production floor while helping to perform equipment setup, operation and troubleshooting.
• Maintain machine uptime, perform fault clearing and clear stoppages on automated equipment.
• Ensure all safety and compliance procedures are followed at all times.
• Escalate appropriate concerns to various levels of management when personnel and environmental safety, equipment functionality, product supply, or quality are at risk.
• Provide training to manufacturing staff on process and equipment.
• Provide troubleshooting, technical support, and resolution of equipment, automation, and process issues on the manufacturing floor.
• Collaborate with Quality, Engineering and Manufacturing Support to resolve manufacturing events in a timely manner.
• Support Deviation Triage and Corrective and Preventive Actions (CAPA) processes
• Write, review & revise controlled documentation (SOPs, Manufacturing Procedures (MPs), Forms, Technical Reports, etc)
• Apply process, scientific, operational, and compliance knowledge with analytical and troubleshooting skills to support manufacturing operations.
• Champion Lean Transformation and OE initiatives, facilitate the drive towards continuous improvement in the plant.
• Participate in the design, development, and implementation of processes in support of the manufacturing floor.
• Participate in the development, implementation, and issue resolution associated with process equipment Commissioning, Qualification and Validation.
• Collaborate with Quality, Mfg Managers, Plant Engineering, Process Development and Regulatory Compliance staff in cross-functional teams.

Qualifications

• Basic Qualifications:
  • High school/GED + 4 years biotech or pharmaceutical manufacturing, process development or quality experience
  • Or Associate‚Äôs + 2 years biotech or pharmaceutical manufacturing, process development or quality experience
  • Or Bachelor‚Äôs + 6 months biotech or pharmaceutical manufacturing, process development or quality experience
  • Or Master‚Äôs
• Preferred Qualifications:
  • Degree in Chemical Engineering, Industrial Engineering or Life Sciences
  • Technical understanding of pharmaceutical/biotech packaging equipment and processes
  • Experience with Current Good Manufacturing Practices (cGMP)
  • Ability to be flexible and manage change
  • Experience participating in and leading cross-functional teams
  • Experience in managing multiple, competing priorities in a fast-paced environment
  • Strong scientific, technical interactions with partner organizations such as PD and F&E
  • Experience in GMP Tech Support roles, GMP operations, process development or scheduling
  • Experience with Commissioning and Qualification, New Product Introduction, Cleaning Validation, and Process Performance Qualification
  • Ability to organize, analyze, and interpret technical data that is impacting operations
  • Background in lean manufacturing methodologies and operational excellence
  • Expertise in electronic systems used in manufacturing (MES, LIMS, Maximo, CCMS, SAP, etc.)

Skills

• Process troubleshooting
• Equipment operation and maintenance
• Documentation writing and review (SOPs, MPs, forms, technical reports)
• Cross-functional collaboration
• Lean transformation and continuous improvement
• Data analysis and interpretation

Education

• Not specified beyond qualifications; degrees listed in Preferred Qualifications

Additional Requirements

• Extensive experience with cGMP environments and manufacturing operations
• Ability to work on a 12-hour shift (6:00am ‚Äì 6:00pm)