Pfizer
Sr. Aseptic Process Engineer
This job is now closed
Job Description
- Req#: 4904982
- 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 practices
- Applicant must have a High School Diploma (or Equivalent) and 8 years of relevant experience OR an associates degree with 6 years of experience OR a bachelors with at least 3 years of experience OR Masters with more than 1 year of experience.
- 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
- May be required to work non-standard work hours
- Relevant pharmaceutical experience
- Knowledge of site operations
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 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 dynamic engineering team, you will play a critical part in provides technical or business support to engineers on a variety of technical tasks. Your documentation skills will come in handy to prepare engineering documentation, reports and drawings. You will be conducting preliminary analysis of trajectory adequacy data, model dimensional consistency and quantitative judgements concerning technical data. You will also support the team by conducting tests and recording data to assist engineering evaluations.
As a Senior Associate, your knowledge and skills will contribute towards the goals and objectives of the team. Your 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 focus that will make Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
Qualifications
Must-Have
Nice-to-Have
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.
Engineering #LI-PFEEEO & 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.
About the company
At Pfizer we know that great things happen anywhere people come together with one shared goal. And the greatest rewards are sometimes where you least expect them. The future of medicine is happening at Pfizer.
Notice
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