Bioprocess Technician IV - Night Shift , mAbs

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

• United States - North Carolina - Sanford

We’re in relentless pursuit of breakthroughs that change patients’ lives. We innovate every day to make the world a healthier place.

To fully realize Pfizer’s purpose – Breakthroughs that change patients’ lives – we have established a clear set of expectations regarding “what” we need to achieve for patients and “how” we will go about achieving those goals.

Pfizer Global Supply proudly shoulders the responsibility of manufacturing and distributing our wide-ranging pharmaceutical products.

Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues.

Transforming Delivery of high quality products

Pfizer, We are one

PGS - Manufacture the Future

Our breakthroughs would not reach the hands of patients without our dedicated pharmaceutical manufacturing team. We rely on agile members who understand the critical impact of their role in Pfizer’s mission. Patients need colleagues like you who take pride in their work and continuously strive to improve outcomes. Your efforts ensure that patients and physicians have timely access to the medicines they need.

• 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 issue resolution associated with process equipment commissioning, qualification and validation.
• Drive troubleshooting, technical support/analysis and resolution of equipment, automation, and process issues on the manufacturing floor.
• Drive for Right first time and continuous improvement execution, the timely review of daily documentation and complete data entry; identify and/or communicate process and compliance concerns in real time.
• Support audits and observation improvements.
• Collaborate with the Subject Matter Expert for manufacturing operations in support of QTS investigations and CAPA implementations.
• Remain current on assigned training.
• Implement Lean Manufacturing, Sustainability, Operational Excellence initiatives; facilitate the drive towards continuous improvement in all manufacturing areas.
• Collaborate in the escalation process through various levels of management 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.
• Proficient in enterprise systems to support manufacturing operations including but not limited to SAP, LIMS, AMPS, PDOCS and/or QTS.
• Participate in performance of cleaning, inventory, and maintaining facility in a safe and GMP compliant manner.

• High School Diploma or GED and 4+ years of experience, particularly in a pharmaceutical or other cGMP (Current Good Manufacturing Practices) environment, or Associate plus 2 years of work experience, or Bachelors plus 0 years of work experience 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.

• Experience in a pharmaceutical manufacturing environment.
• 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.

• 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.
• 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…