Bioprocess Technician IV (Gene Therapy)

Employer
Pfizer
Location
Sanford, North Carolina, United States
Posted
Sep 12, 2020
Ref
4771187
Required Education
High School or equivalent
Position Type
Full time
ROLE SUMMARY

The Bioprocess Technician (BPT) IV will be knowledgeable of process equipment and systems, manufacturing operations, and automation control (PLC, Delta V, etc), and their primary responsibility will be to plan for and execute process and equipment operation activities during manufacturing operations. The BPT IV will perform on the floor analytical assays and will assist with production planning and provide support coordinating production activities across applicable Manufacturing functional areas that include: solution preparation, upstream processing, downstream processing and Drug Product filling. The BPT IV will be accountable for the required training, documentation and technical completion of work as required in a regulated cGMP environment.

The BPT IV provides process execution and equipment operational activities in support of cGMP commercial manufacturing. Provides organizing role to ensure appropriate scheduling of activities and ensure production supplies are available for the day's operations. The BPT IV works directly with Management, Leads/Coordinators and Process Engineers in the resolution of issues to fulfill manufacturing requirements during the shift of operation. The BPT IV conducts all activities that are in accordance with company policies & SOPs, Pfizer Values, and global regulatory guidelines (including cGMP/cGLP/cGCP), environmental guidelines, as appropriate, etc. Advises management of non-conformance issues and opportunities for continuous improvement.

ROLE RESPONSIBILITIES

The incumbent is a skilled manufacturing technician/operator with knowledge of any of the following: solution preparation, upstream processing, downstream processing and Drug Product filling. The incumbent is knowledgeable of required processing unit operations and control systems needed for operations. The incumbent performs scientific and operational tasks related to commercial manufacturing.

Job responsibilities include:
  • Organize daily functions and work in concert with Bioprocessing Technicians in executing those functions in a safe, compliant, and efficient manner to maintain production schedules. Must be able to make recommendations to changes in the schedule and recommendations to re-direct activities as necessary to minimize impact to quality, compliance and timelines.
  • In addition to on the floor analytical testing, processing, cleaning, and operating major process equipment (tanks, bioreactors , ultrafiltration units, centrifuges, etc.), job duties also include routine production preparation tasks such as preparing production glassware and other equipment by operating industrial washers and autoclaves, use calibrated scales to weigh out dry components and use graduated cylinders and flasks to measure liquids. Also, performs analytical activities such as: performing sample dilutions, pH, and conductivity readings.
  • Requires understanding of scientific principles, operational aspects of production equipment, automation control


BASIC QUALIFICATIONS

High school diploma with a minimum of three years manufacturing or pharmaceutical experience; OR Associate's Degree with two years of industry experience; OR Bachelor's Degree required.

PHYSICAL/MENTAL REQUIREMENTS
  • Moderate repetitive standing, sitting, bending, ladder climbing, pushing and lifting (up to 40lbs) required on a daily basis.
  • Ability to perform mathematical calculations, follow procedure, complete proper documentation, and learn new processes.


NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

16/5 coverage via 8 hour rotating shifts (1st and 2nd) with overtime through June of 2020. In July 2020, area will move to 24/7 coverage via 12 hour set shifts with overtime.

Other Job Details:
  • Last Date to Apply for Job: 9/15/2020
  • Eligible for Employee Referral Bonus


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.

Sunshine Act

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.

Sunshine Act

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.

Manufacturing