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

Role Summary

Bioprocess Technician IV on Day Shift (6am-6pm) supporting mAbs manufacturing. Responsible for executing production operations on the manufacturing floor, ensuring compliance with cGMP and safety regulations, and driving continuous improvement. Collaborates with subject matter experts and supports investigations and CAPA implementations to ensure timely, compliant production and quality outcomes.

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.
• Follows SOPs and batch records for unit operations.
• Supports operation of manufacturing equipment and issue resolution related to 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, reviews daily documentation, completes data entry, and identifies or communicates 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.
• Stays current on assigned training.
• Implements Lean Manufacturing, Sustainability, Operational Excellence initiatives to drive continuous improvement in all manufacturing areas.
• Escalates issues through management when operations, safety, equipment functionality, product supply, or quality compliance are at risk.
• Ensures work requests are generated when issues arise with facility or manufacturing equipment.
• Proficient in enterprise systems to support manufacturing operations including SAP, LIMS, AMPS, PDOCS and/or QTS.
• Maintains cleaning, inventory, and facility safety and GMP compliance.

Qualifications

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

Skills

• Ability to train and mentor less-experienced colleagues (Preferred).
• Knowledge of process improvement methodologies (Preferred).
• Ability to work independently and as part of a team (Preferred).
• Attention to detail and commitment to quality (Preferred).
• Adaptability and flexibility in a dynamic work environment (Preferred).

Education

• High School Diploma or GED and 4+ years of relevant experience, or Associate/Bachelor as noted in qualifications (as applicable).

Additional Requirements

• Physical requirements: ability to move heavy equipment and lift ~40 pounds; moderate standing, sitting, bending, and ladder climbing; safety precautions for pressurized systems, steam, and corrosive chemicals; ability to follow SOPs and MBRs; proficiency with SAP, DeltaV, and other enterprise systems.
• Non-Standard Work Schedule: supports a 24/7 facility on a 2-2-3 schedule; day shift 6am-6pm.