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

Role Summary

Bioprocess Technician IV will execute manufacturing operations on the production floor across bioprocess equipment with varying levels of automation, including buffer/media make-up tanks, glass washers, autoclaves, bioreactors/fermentors, filtration equipment, inoculum preparation, chromatography skids and/or UF/DF skids. The role follows SOPs and batch records for unit operations and supports operation of manufacturing equipment, including commissioning, qualification and validation. It drives troubleshooting, supports right-first-time and continuous improvement efforts, and communicates process and compliance concerns in real time. The role supports audits and CAPA implementations, collaborates with the subject matter expert for manufacturing operations, maintains current training, and participates in Lean, sustainability and operational excellence initiatives. It coordinates with management to mitigate risk to operations, product supply and quality compliance. The position is on-site in a 24/7 facility on a 2-2-3 schedule for the day shift (6am–6pm).

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.
• Preferred: Experience in a pharmaceutical manufacturing environment.
• Preferred: Knowledge of process improvement methodologies.
• Preferred: Ability to train and mentor less-experienced colleagues.
• 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.

Additional Requirements

• Requires the moving of heavy equipment and the ability to lift approximately 40 pounds.
• Moderate repetitive standing, sitting, bending, and ladder climbing on a daily basis.
• The incumbent needs to take the necessary safety precautions when working with pressurized systems, steam, and corrosive chemicals.
• The incumbent is required to attain knowledge of the operational equipment.
• The incumbent will be required to assist in solving problems regarding site assessment, specific units used in Biopharmaceutical manufacturing.
• The incumbent must be able to follow SOPs, MBRs and be able to use a multitude of enterprise systems including SAP, Delta-V, etc.
• Supports a 24/7 facility; 2-2-3 schedule; Day shift 6am-6pm.