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Aseptic Process Investigation Engineer


Rocky Mount, NC
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Job Details

The primary function of this position is to support the aseptic manufacturing areas by investigating any assigned deviations. The Aseptic Process Investigation Engineer 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 BQ, Operation, Maintenance, Validation and MQ to deliver key milestones for projects.

+ 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

+ Requires Bachelor's Degree in a technical field, such as Engineering with 2+ year experience pharmaceutical quality environment 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

+ **Last Date to Apply for Job: September 4, 2017**

+ **Grade:14**

**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.

**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.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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