Why Patients Need You
Our breakthroughs would not make it to the hands of patients without our pharmaceutical manufacturing team. We rely on a team of dedicated and agile members, who understand the importance and impact of their role in Pfizer’s mission. Patients need colleagues like you who take pride in their work and always look to improve outcomes. You will help to ensure that patients and physicians have the medicines they need, when they need them.
What You Will Achieve
You will be accountable for activities involved in the production of drug substance or active biological ingredients (ABI). You will assist in a wide variety of activities and functions while supporting a manufacturing facility following Good Manufacturing Practices and ensuring compliance with Pfizer Standard Operating Procedures (SOPs) along with all applicable worldwide regulations and guidelines.
As part of technical operations, you will be a team member who is relied to have a good understanding of procedures, techniques, tools, materials and equipment. Your decision making will help you prioritize workflows based on the available resources. You will follow standard procedures to complete tasks, some of which may vary in scope, sequence, complexity and timing. You will contribute to the team’s success by sharing your previously acquired knowledge.
It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.
The Senior Process Technician drives the execution of Commercial, Clinical, and/or Development production according to Standard Operating Procedures and Production Schedule. The Senior Process Technician will work on interdisciplinary self-directed teams, to define and implement process improvements, participate in process troubleshooting.
- Ensure adherence to all plant safety rules in the area of responsibility and (Current) Good Manufacturing Practices (part of GxP) for products and processes.
- Maintain area housekeeping standards and environmental specifications by using a variety of sanitizing aids.
- Support implementation of new technology for process execution and/or analysis.
- Maintain current training status on all applicable standard operating procedures.
- Execute Standard Operating Procedures for unit operations.
Executes manufacturing operations on the production floor for buffer/media make-up tanks, glass washers, autoclaves, bioreactors, filtration equipment, inoculum preparation, chromatography skids and/or UF/DF skids with varying levels of automation.
Executes the execution of SOPs for unit operations including but not limited to, CIPs, SIPs, Sanitization, etc.
Implements the execution 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.
Experience in a GMP manufacturing environment is desired.
Familiarity and experience with either purification processes or mammalian cell culture.
Ability to interpret and prioritize workflow to maintain the production schedule.
Effective verbal and written communication skills.
Drives for Right first time execution, the timely review of daily documentation and executes data entry; Monitor, Identify and/or Communicate process and compliance trends inreal time.
Supports the assigned audit lead for walkthroughs/GMP100s and observation improvements.
View Role for controlled documentation; SOPs, Manufacturing Batch/Formulation Records, Forms, etc.
Collaborates with the Subject Matter Expert for manufacturing operations in support of QTS investigations and CAPA implementations.
Responsible for remaining current and reviews curriculum for training programs in support of manufacturing processes.
Implements Lean Manufacturing, Sustainability, Operational Excellence initiatives; facilitate the drive towards continuous improvement in all manufacturing areas.
Collaborates with cross-functional manufacturing assets in support of manufacturing campaigns.
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 manufacturing equipment.
Proficient in enterprise systems to support manufacturing operations including but not limited to, SAP, LIMS, AMPS, PDOCS and/or QTS.
Operates production sustainability through the performance of inventory accuracy, reconciliation and/or task prioritization to maintain metric adherence
Requires the moving of heavy equipment and the ability to lift ~50 pounds. The incumbent needs to take the necessary safety precautions when working with pressurized systems, steam, and corrosive chemicals.
The incumbent is required to attain detail knowledge of the operational equipment.
The incumbent will be required to solve problems regarding site assessment, specific units used in Biopharmaceutical manufacturing.
The incumbent must be able to express ideas into SOPs, MFRs and be able to use a multitude of programs including Excel, Word, Power Point, etc.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
2nd shift 2pm - 2am, rotating
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.