The Bioprocess Technician IV drives the execution of Commercial, Clinical, and/or Development production according to Standard Operating Procedures and Production Schedule. The Bioprocess Technician IV will work on interdisciplinary teams, to define and implement process improvements, and participate in process troubleshooting.ROLE RESPONSIBILITIES
Executes manufacturing operations on the production floor for buffer/media make-up tanks, glass washers, autoclaves, bioreactors / fermentors, drug product filling, 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.
High School diploma and 4 years of work experience required.
Associate plus 2 years of work experience
Bachelors plus 0 years of work experience preferred
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS OTHER JOB DETAILS
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 proficient 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 proficient in a multitude of enterprise systems including SAP, Delta-V, etc.
Work Location Assignment:On Premise
Relocation assistance may be available based on business needs and/or eligibility.
Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.