Bioprocess Technician IV - Night Shift 6pm-6am, mAbs
PfizerAbout the role
Use Your Power for Purpose
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.
What You Will Achieve
In this role, you will:
Executes manufacturing operations on the production floor for Downstream/Purification 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.
Here Is What You Need (Minimum Requirements)
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
Bonus Points If You Have (Preferred Requirements)
Experience in a pharmaceutical manufacturing environment
Knowledgeof 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
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 operational equipment.
The incumbent will be required to assist in solving problems regarding site assessment, specific units used in Biopharmaceutic
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