Job Description
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
Your knowledge of the manufacturing domain will help in understanding of process equipment and systems, manufacturing operations, and automation control. Your primary responsibility will be to plan for and execute process and equipment operation activities during manufacturing operations. You will assist with production planning and provide / support coordinating production activities, working with the Clinical Manufacturing Team Leads and Process Engineers.
You will provide training for operational qualifications and assist the Team Lead and Process Engineer in assuring all personnel are appropriately trained for the applicable tasks. You will provide process execution and equipment operational activities in support of cGMP (current Good Manufacturing Practices) clinical and /or commercial manufacturing. You will advise management of non-conformance issues and opportunities for continuous improvement. As an associate, your focus on the job will contribute in achieving project tasks and goals. Through your domain knowledge and commitment, you will create a collaborative teaming environment for your colleagues.
It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
- Contribute to completion of project milestones and organize own work to meet project task deadlines.
- Assess challenges to the schedule and re-directing activities as necessary to minimize impact to quality, compliance and timelines.
- Capable of detecting technical problems and assisting the appropriate colleagues for resolution.
- Perform routine production preparation tasks such as preparing production glassware and other equipment by operating industrial washers, autoclaves and dehydrogenation ovens, use calibrated scales to weigh out dry components and use graduates and flasks to measure liquids.
- Able to collect and assemble applicable, vital information for recommendations to Production Supervisors and/or Manufacturing Process Engineers to assist in troubleshooting and decision making.
- Organize daily functions and work in concert with Bioprocessing Technicians in executing operational aspects for Fermentation, Purification, and Conjugation processing in a compliant, safe and efficient manner to maintain production schedules.
- Understand scientific principles, operational aspects of production equipment, automation control systems, processing requirements and any related procedural requirements.
- Develop best practices and share with other teams and sites.
- Conduct all activities that are in accordance with company policies and Standard Operating Procedures, Pfizer Values, and global regulatory guidelines, environmental guidelines, as appropriate, etc.
- Perform laboratory activities such as performing sample dilutions, pH, and conductivity readings.
- Provide input and revise Standard Operating Procedures, batch records, forms or other {Current} Good Manufacturing Practices {part of GxP} related documents to support continuous improvement efforts, investigation corrective actions etc.
- Track and follow-up on departmental commitments, investigations, change controls, change control and general compliance initiatives.
Qualifications
Must-Have
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Applicant must have a High School Diploma (or Equivalent) and 6 years of relevant biopharmaceutical industry OR an Associates degree with 4 years of biopharmaceutical industry experience OR a Bachelors degree with 0+ years of biopharmaceutical industry experience.
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Demonstrated experience in Food and Drug Administration regulated industry
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Ability to perform mathematical calculations and learn new processes.
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Proactive in engagement with key stakeholders
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Excellent verbal and written communication skills
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Ability to efficiently use current computer packages including Excel, PowerPoint, MS Project and Word
Nice-to-Have
- Experience in a biopharmaceutical or pharmaceutical Good Manufacturing Practices
- Experience with cell banking-related activities, aseptic technique, experience working in a cleanroom a plus.
- Knowledge of operational aspects for Fermentation, Purification, and Chemistry processing
Non-Standard Work Schedule, Travel, or Environment Requirements
- This role is standard day Monday through Friday work shift; some off-shift support needed when issues arise.
Other Job Details:
- Last day to Apply: May 29th, 2023.
- Eligible for Relocation Assistance: YES/NO
- Work Location Assignment: On Premise
Relocation assistance may be available based on business needs and/or eligibility.
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
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