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

Role Summary

Bioprocess Technician IV - 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 and issue resolution associated with process equipment commissioning, qualification and validation.
• Drives troubleshooting, technical support/analysis and resolution of equipment, automation, and process issues on the manufacturing floor.
• Drives for Right first time and continuous improvement execution, the timely review of daily documentation and completes data entry; Identify and/or Communicate process and compliance concerns in real time.
• Supports audits and observation improvements.
• Collaborates with the Subject Matter Expert for manufacturing operations in support of QTS investigations and CAPA implementations.
• Responsible for remaining current on assigned training.
• Implements Lean Manufacturing, Sustainability, Operational Excellence initiatives; facilitate the drive towards continuous improvement in all manufacturing areas.
• Collaborates in the escalation process through various levels of management when operations, personnel safety, equipment functionality, product supply and/or quality compliance are at risk.
• Ensures work requests are generated when issues arise with facility / manufacturing equipment.
• Proficient in enterprise systems to support manufacturing operations including but not limited to, SAP, LIMS, AMPS, PDOCS and/or QTS.
• Ensure and participates in performance of cleaning, inventory, and maintaining facility in a safe and GMP compliant manner.

Qualifications

• Required: High School Diploma or GED and 4+ years of experience, particularly in a pharmaceutical or other cGMP environment or Associate plus 2 years of work experience or Bachelors plus 0 years of work experience preferred
• Required: Effective verbal and written communication
• Required: Proficiency in operating and troubleshooting production equipment
• Required: Strong understanding of cGMP and safety regulations
• Required: Ability to maintain accurate documentation and records
• Required: Experience in a clean room environment
• Required: Competence in using automated and enterprise systems
• Required: Effective cross-functional communication skills

Skills

• Production equipment operation and troubleshooting
• Quality systems and documentation control
• Cross-functional collaboration
• Process improvement and continuous improvement mindset

Education

• Not specified beyond minimum qualifications; include any relevant degrees or certifications if present in source

Additional Requirements

• Physical: Requires the moving of heavy equipment and the ability to lift ~40 pounds.
• Physical: Moderate repetitive standing, sitting, bending, and ladder climbing daily.
• Safety: Knowledge of safety precautions when working with pressurized systems, steam, and corrosive chemicals.
• Operational: Unable to follow SOPs and MBRs and use enterprise systems including SAP, Delta-V, etc.
• Scheduling: Supports a 24/7 facility; 2-2-3 schedule; Day shift 6am-6pm.