Bioprocess Technician IV - Day Shift , mAbs

Position: Bioprocess Technician IV - Day Shift 6am-6pm, mAbs
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** 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.
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** What You Will Achieve
** In this role, you will:
* 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.  #
** 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
* 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
*** 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 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.  #
** Non-Standard work schedule, travel or environment requirements
*** Supports a 24/7 facility.
* 2-2-3 schedule. Day shift 6am-6pm.  
** OTHER

JOB DETAILS
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