Sr. Aseptic Process Engineer

Company: Pfizer
Location: Rocky Mount
Posted on: November 12, 2021

Job Description:

Why Patients Need YouWhether 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 engineering team, you'll help bring medicines to the world even faster by imagining what's possible and taking action.What You Will AchieveThe primary function of this position is to support the aseptic manufacturing areas in R1, R2 and R3. The Sr. Aseptic Process Engineer and his/her team is responsible for supporting the planning, execution, tracking, and completion of key aseptic related projects such as but not limited to: PQS implementation, shut down/restart process, media fill oversight, investigation and change management. This candidate must be able to work cross functionally with Operation, Maintenance, Validation, Process Engineering and MQ to deliver key milestones for projects. In addition, this candidate will be responsible for 1-3 aseptic process engineers. How You Will Achieve It

• Conducts and writes formal investigation reports with the assistance of plant personnel for Technical Sterility Services
• Performs impact risk assessment as well as assist in root cause determination and plans appropriate corrective action and preventative action.
• Track, close, and implement CAPAs for Technical Sterility Services
• Performs reviews and evaluates sensitive, confidential information and develops recommendations for use by Technical Sterility Services department
• Utilize change management systems to update documents and procedures
• Liaise with departments such as Manufacturing and Quality as required to meet project deadlines
• Perform necessary assessments of aseptic operation and update necessary documents
• Assist in managing investigation workload for the department to ensure investigations/ CAPA's are completed within the assigned time frame
• Responsible for maintaining working knowledge of cGMPs and emerging regulatory and compliance concerns as related to aseptic manufacturing
• Develop and coach direct reports on aseptic practicesQualificationsMust-Have
  • Bachelor's Degree in a technical field, such as Engineering with minimum 3 years of experience in aseptic manufacturing or pharmaceutical related experience is required.
  • Requires thorough knowledge of GMP's and understanding in aseptic processing.
  • Must have the ability to handle multiple projects in a dynamic environment.
  • Must be self-directed and requires an appropriate level of education and experience to make and act upon decisions that impact the site from an aseptic standpoint.
  • Pharmaceutical operations experience and/or knowledge.
  • Working knowledge of FDA regulations.
  • Knowledge of various quality tools.
  • Prior investigation writing experience (with determination of product impact).
  • Excellent facilitation skills and ability to facilitate strategy meetings.
  • Superior technical writing and problem solving skills.
  • Organize data, extract key information and write technical summary reports.
  • Expertise with word-processing, spreadsheet, and presentation software.
  • Ability to interface with multiple levels of people in the organization, including plant personnel and senior management.
  • Must be able to function under a stressful situation while being able to remain focused at the necessary requirements. In addition, must be able to appropriately identify and escalate issues on a timely basis.
  • Must be able to work on weekend, off shifts and holiday as business demands.
  • Must be able to work in a team setting and willing to lead others.PHYSICAL/MENTAL REQUIREMENTS Must be able to function under a stressful situation while being able to remain focused at the necessary requirements. In addition, must be able to appropriately identify and escalate issues on a timely basis. NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS Must be able to work on weekend, off shifts and holiday as business demands.OTHER JOB DETAILS:
    • Last day to apply: 11/12/2021
    • Eligible for Relocation PackagePfizer 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.Sunshine ActPfizer 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 EligibilityPfizer 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

Keywords: Pfizer, Rocky Mount , Sr. Aseptic Process Engineer, Engineering , Rocky Mount, North Carolina