Associate Engineer, Clinical Manufacturing, Fermentation
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
You will be part of a multi-disciplinary team responsible for cGMP (current Good Manufacturing Practices) production of phase I/II clinical drug substance supporting the Pfizer Biotherapeutics portfolio. Your initial focus is on the start-up of a new facility in support of facility/equipment commissioning and qualification, creation of necessary cGMP documentation, and training of operations staff. After the start of the facility, you will transition to a team that will be responsible for the execution of microbial upstream and downstream processes.
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 team environment for your colleagues.
It is your hard work and focus that will help in making Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
Contribute to the completion of complex projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.
Support completion of Good Manufacturing Practices {also cGMP} documentation.
Execute and troubleshoot downstream mammalian and microbial purification processes in a cGMP {part of GxP} environment.
Support tech transfer activities for new products and product changeover for operations team.
Identify and support the resolution of quality concerns and contribute to the subsequent investigational reports within the quality system.
Make recommendations for continuous improvement opportunities with regard to safety, quality, and efficiency.
Assist with associated tooling, change parts and perform in-process operational checks associated with clinical manufacturing.
Work in electronic systems including QMS, Documentation, Laboratory Information Management System Enterprise Resource Planning (e.g.: SAP) etc.
Understand data integrity principles and application within systems.
Work on supporting and troubleshooting of process equipment and Clean-in-place (CIP) and Steam-in-place (SIP) operations.
Qualifications
Must-Have
Bachelor's Degree with 0-2 years of experience with Tech Transfer, Facility Fit assessments and engineering design
Demonstrated experience in a biotechnology manufacturing or laboratory environment
Ability to execute against Standard Operating Procedures and document entries in a compliant manner
Demonstrated capability to work as a team member in a matrix development team.
Maintains a safe work environment
Excellent oral and written communication skills
Strong analytical and computer skills
Nice-to-Have
Prior experience in a Biological Pilot Plant or Commercial Manufacturing setting
PHYSICAL/MENTAL REQUIREMENTS
Ability to effectively gown into and operate in a clean room environment for extended periods of time. Gowning may include full coveralls, face mask, head cover, boots and gloves. Ability to lift up to 25 lbs.
Ability to stand and walk for extended periods of time.
Ability to operate forklift or Master Mover for heavy loads.
Ability to perform algebraic mathematical calculations and follow Standard Operating Procedures.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Ability to effectively gown into and operate in a clean room environment for extended periods of time. Gowning may include full coveralls, face mask, head cover, boots and gloves.
Ability to work non-standard hours as required including occasional evenings or overnights or weekends. Typical work schedule is 7AM – 330PM M-F. Non-standard hours are typically on a volunteer basis and are avoided when possible, however it is unavoidable at times.
There is no travel expected with this role.
Other Job Details:
Last Date to Apply for Job: April 1st, 2024
Work Location Assignment: On Premise
On Premise colleagues work in a Pfizer site because it’s needed to get their job done. They may have flexibility to work remotely from time to time, but they are primarily on-site.
The annual base salary for this position ranges from $54,700.00 to $91,100.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 7.5% of the base salary. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.
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. This position requires permanent work authorization in the United States.
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.
