Why Patients Need You
Whether you are involved in the design and development of manufacturing processes for products or supporting maintenance and reliability, engineering is vital to making sure customers and patients have the medicines they need, when they need them. Working with our innovative operations and engineering team, you'll help bring medicines to the world even faster by imagining what's possible and taking action.
What You Will Achieve
Working with Pfizer's Gene Therapy Operations team you will develop and implement a strategy for use of single-use technology (SUT) in Gene Therapy (GTx). Inputs for strategy will include review design and feedback from operations, as well as leveraging learnings and best practices from across Pfizer network currently using similar single use technology/equipment/designs. Also, leverage and enhance existing relationships with SUT vendors to support strategy for GTx commercial cadence.
Reduce the losses associated with SUT work in partnership with cross functional groups to identify, track and resolve those issues across the Sanford GTx facilities.
As a Senior Associate, your knowledge and skills will contribute towards the goals and objectives of the team. Your focus and ability to meet team targets will help in completing critical deliverables. Your innovative use of communication tools and techniques will facilitate in explaining difficult issues and establishing consensus between teams.
It is your hard work and dedication that will make Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
Drive for standardization in SUT across all GTx areas to reduce complexity and overall cost.
Provide input into SUT designs that support right first time execution.
Serve as point of contact with GTx Operations team in translating process requirements into SUT design/modifications
Transfer knowledge of SUT design to Operations team.
Develop SUT enrollment strategy (sterile, packaging, expiry, and vendor suitability)
Review and evaluate supplier complaint responses as required, identifying suitable CAPAs to address supplier quality issues across GTx Operations
Provide in-depth technical expertise to support supplier quality and technical issues
Act as the technical point of escalation for systemic quality issues originating from suppliers
Collate and present data to GTx Operations leadership at Business Review Meeting
Lead with Site Supply Chain, technical visits at suppliers to understand the supplier's manufacturing process and identify opportunities for improvements within these processes
Lead data driven CI initiatives and participate in specification alignment projects with suppliers through technical solutions that lead to improved quality at the suppliers
Contribute to the completion of projects, manage own time to meet agreed targets and develop plans for short-term work activities on own projects.
Adhere to site safety standards, participate in routine safety training events, and enforce safety and biosafety requirements as they relate to the manufacturing department.
Qualifications
Must-Have
Applicant must have a High School Diploma (or Equivalent) and 8 years of relevant experience OR an Associate's degree in Engineering or Science preferred with 6 years of experience OR a Bachelor's degree in Engineering or Science preferred with at least 3 years of experience OR Master's degree in Engineering or Science preferred with more than 1 year of experience.
Knowledge of Good Manufacturing Practices and experience in pharmaceutical environment
Experience of project orientated admin/cost control/management
Experience with designing single use technology (SUT) systems for biotech manufacturing
Experience in analyzing component defect/quality issues and working with suppliers to resolve the same
Nice-to-Have
Relevant pharmaceutical experience
Knowledge of the manufacturing process and equipment, using SUT
Hands on experience using SUT
Experience in mammalian cell culture manufacturing
Physical / Mental requirements
Position requirements are typical for a manufacturing plant-based work environment with shop floor exposure in manufacturing and utilities.
Ability to gown in manufacturing areas and provide shop floor support.
There are no unusual physical or mental requirements for this position.
Non-Standard work schedule, travel or environment requirements
This role requires the colleague to work on the floor of the GTx manufacturing areas including BL-2 zones to observe SUT component defects and handling issues.
Aseptic gowning could be required.
Travel to visit component vendors suppliers may be required.
Other job details
Last day to apply: February 2nd, 2024
Employee Referral Bonus eligible
Work Location Assignment:On Premise
The annual base salary for this position ranges from $78,000.00 to $126,300.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 10.0% 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.
Engineering
#LI-PFE