Bioprocess Technician IV - Night Shift 6pm-6am, mAbs
Pfizer
9 hours ago
On-site
North Carolina, United States
Operations
What You Will Achieve
In this role, you will:
- Execute manufacturing operations on the production floor for Downstream/Purification with varying levels of automation.
- Follow SOPs and batch records for unit operations.
- Support operation of manufacturing equipment and resolve issues related to process equipment commissioning, qualification, and validation.
- Drive troubleshooting and provide technical support/analysis to resolve equipment, automation, and process issues.
- Execute right-first-time and continuous improvement; review daily documentation, complete data entry, and identify/communicate process and compliance concerns in real time.
- Support audits and observation improvements.
- Collaborate with the Subject Matter Expert on manufacturing operations in support of QTS investigations and CAPA implementations.
- Stay current on assigned training.
- Implement Lean Manufacturing, Sustainability, and Operational Excellence initiatives to drive continuous improvement.
- Participate in escalation when operations, personnel safety, equipment functionality, product supply, and/or quality compliance are at risk.
- Ensure work requests are generated when issues arise with facility/manufacturing equipment.
- Use enterprise systems to support manufacturing operations, including SAP, LIMS, AMPS, PDOCS, and/or QTS.
- Perform cleaning, maintain inventory, and maintain the facility in a safe and GMP-compliant manner.
Here Is What You Need (Minimum Requirements)
- High School Diploma or GED and 4+ years of experience in a pharmaceutical or other cGMP environment; or Associate + 2 years; or Bachelor’s + 0 years (preferred).
- 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.
Bonus Points If You Have (Preferred Requirements)
- Experience in pharmaceutical manufacturing.
- Knowledge of process improvement methodologies.
- Ability to train and mentor less-experienced colleagues.
- Ability to work independently and as part of a team.
- Attention to detail and commitment to quality.
- Adaptability and flexibility in a dynamic work environment.
Physical / Mental Requirements
- Move heavy equipment; ability to lift ~40 pounds.
- Moderate repetitive standing, sitting, bending, and ladder climbing daily.
- Follow safety precautions when working with pressurized systems, steam, and corrosive chemicals.
- Attain knowledge of operational equipment and assist with problem-solving regarding site assessment and biopharmaceutical manufacturing units.
- Follow SOPs/MBRs and use enterprise systems including SAP and Delta-V.
Work Schedule
- Supports a 24/7 facility; 2-2-3 schedule (night shift 6pm–6am and/or day shift 6am–6pm).
Benefits (explicitly stated)
- 401(k) with Pfizer matching contributions and additional Pfizer retirement savings contribution; paid vacation/holidays/personal days; paid caregiver/parental and medical leave; medical, prescription drug, dental, and vision coverage.
In this role, you will:
- Execute manufacturing operations on the production floor for Downstream/Purification with varying levels of automation.
- Follow SOPs and batch records for unit operations.
- Support operation of manufacturing equipment and resolve issues related to process equipment commissioning, qualification, and validation.
- Drive troubleshooting and provide technical support/analysis to resolve equipment, automation, and process issues.
- Execute right-first-time and continuous improvement; review daily documentation, complete data entry, and identify/communicate process and compliance concerns in real time.
- Support audits and observation improvements.
- Collaborate with the Subject Matter Expert on manufacturing operations in support of QTS investigations and CAPA implementations.
- Stay current on assigned training.
- Implement Lean Manufacturing, Sustainability, and Operational Excellence initiatives to drive continuous improvement.
- Participate in escalation when operations, personnel safety, equipment functionality, product supply, and/or quality compliance are at risk.
- Ensure work requests are generated when issues arise with facility/manufacturing equipment.
- Use enterprise systems to support manufacturing operations, including SAP, LIMS, AMPS, PDOCS, and/or QTS.
- Perform cleaning, maintain inventory, and maintain the facility in a safe and GMP-compliant manner.
Here Is What You Need (Minimum Requirements)
- High School Diploma or GED and 4+ years of experience in a pharmaceutical or other cGMP environment; or Associate + 2 years; or Bachelor’s + 0 years (preferred).
- 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.
Bonus Points If You Have (Preferred Requirements)
- Experience in pharmaceutical manufacturing.
- Knowledge of process improvement methodologies.
- Ability to train and mentor less-experienced colleagues.
- Ability to work independently and as part of a team.
- Attention to detail and commitment to quality.
- Adaptability and flexibility in a dynamic work environment.
Physical / Mental Requirements
- Move heavy equipment; ability to lift ~40 pounds.
- Moderate repetitive standing, sitting, bending, and ladder climbing daily.
- Follow safety precautions when working with pressurized systems, steam, and corrosive chemicals.
- Attain knowledge of operational equipment and assist with problem-solving regarding site assessment and biopharmaceutical manufacturing units.
- Follow SOPs/MBRs and use enterprise systems including SAP and Delta-V.
Work Schedule
- Supports a 24/7 facility; 2-2-3 schedule (night shift 6pm–6am and/or day shift 6am–6pm).
Benefits (explicitly stated)
- 401(k) with Pfizer matching contributions and additional Pfizer retirement savings contribution; paid vacation/holidays/personal days; paid caregiver/parental and medical leave; medical, prescription drug, dental, and vision coverage.