Bioprocess Technician III - Day Shift 6am-6pm, mAbs

Role Summary

Bioprocess Technician III - Day Shift 6am-6pm, mAbs

Responsibilities

• Executes manufacturing operations on the production floor for buffer/media make-up tanks, glass washers, autoclaves, bioreactors / fermentors, filtration equipment, inoculum preparation, chromatography skids and/or UF/DF skids with varying levels of automation.
• Follow SOPs and batch records for unit operations.
• Supports operation of manufacturing equipment associated with process equipment commissioning, qualification and validation.
• Assists troubleshooting, technical support/analysis and resolution of equipment, automation, and process issues on the manufacturing floor.
• Strives for Right first time execution and continuous improvement, the timely review of daily documentation and completes data entry; Identify and/or Communicate process and compliance concerns in real time.
• Participate in audits, as required.
• Assists the Subject Matter Expert for manufacturing operations in support of QTS investigations and CAPA implementations.
• Responsible for remaining current on assigned training.
• Supports Lean Manufacturing, Sustainability, Operational Excellence initiatives; facilitate the drive towards continuous improvement in all manufacturing areas.
• Assists in the escalation process through various levels of management when operations, personnel safety, equipment functionality, product supply and/or quality compliance are at risk.
• Escalates the need for work requests when issues arise with facility/manufacturing equipment.
• Utilizes enterprise systems to support manufacturing operations including but not limited to, SAP, LIMS, AMPS, PDOCS and/or QTS.
• Assists in performance of cleaning, inventory, and maintaining facility in a safe and GMP compliant manner.

Qualifications

• Required: High School Diploma or GED with 2+ years of relevant experience, Associate 0 years of experience
• Required: Strong verbal and written communication skills
• Required: Proficiency in using standard manufacturing equipment and tools
• Required: Basic understanding of Good Manufacturing Practices (GMP)
• Required: Ability to follow detailed instructions and standard operating procedures
• Required: Strong problem-solving skills in a structured environment
• Required: Capability to work effectively in a team setting
• Required: Basic computer skills, including familiarity with data entry and reporting systems

Skills

• Experience in a pharmaceutical or biotechnology manufacturing environment (Preferred)
• Knowledge of regulatory requirements and quality systems (Preferred)
• Strong organizational skills and attention to detail (Preferred)
• Ability to adapt to changing priorities and manage multiple tasks (Preferred)
• Demonstrated ability to take initiative and drive continuous improvement (Preferred)
• Strong analytical skills and the ability to interpret technical data (Preferred)

Education

• High School Diploma or GED (required)
• Associate degree (preferred, if listed as experience option)

Additional Requirements

• Requires the moving of heavy equipment and the ability to lift ~40 pounds.
• Moderate repetitive standing, sitting, bending, and ladder climbing on a daily basis.
• Must follow safety precautions when working with pressurized systems, steam, and corrosive chemicals.
• Must be able to follow SOPs, MBRs and use enterprise systems including SAP, Delta-V, etc.