20 days old

Aseptic Process Engineer

Pfizer
Rocky Mount, NC 27804
**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 Aseptic Engineering Team, you will be responsible for the planning, execution, tracking, and completion of key aseptic related projects such as (but not limited to): PQS review/implementation, shut down/restart process, Aseptic Review Board, media fill planning and oversight, investigations, smoke studies, aseptic technique evaluation, sanitation and change management. Your production engineering skills will help in recommending and implementing improvements, modifications or additions that will help in solving problems.



As an associate, your focus on the job will contribute in achieving project tasks and goals. It is your domain knowledge, commitment, collaboration and dedication that will help us achieve new milestones and patients across the globe.



**How You Will Achieve It**



+ Contribute to the completion of project milestones, organize own work to meet project task deadlines and communicate progress on scheduled projects.

+ Lead or support major equipment related investigations and implement equipment corrective or preventative action and performance improvements.

+ Organize testing associated with the development of new process technologies and the support of new product introductions and tech transfers.

+ Ensure integrity and compliance of data according to Standard Operating Procedures.

+ Coordinate all work on scheduled projects (personnel activities, documentation and outside resources).

+ Perform other tasks necessary to support site compliance to Center and regulatory requirements.

+ Perform necessary assessments of aseptic operation and update necessary documents.

+ Present media fill and smoke study programs to auditors.

+ Accumulates key metrics for presentation to Management team, including gowning and aseptic technique observation.

+ Maintain working knowledge of Current Good Manufacturing Practices (cGMPs) and emerging regulatory and compliance concerns as related to aseptic manufacturing.

+ Liaise with cross-functional teams such as Manufacturing, Maintenance, Quality, Engineering, and Aseptic Trainers for projects and tasks that impact the aseptic manufacturing areas.

+ Assist in document preparation and training.



**Qualifications**

**Must-Have**



+ Bachelor's Degree in Engineering or related technical field required.

+ 2+ years of experience in manufacturing required.

+ Demonstrated ability to provide technical solutions for complex problems through equipment and process understanding.

+ Proactive, has experience with high performance teams, strong interpersonal and project management skills.

+ Strong written and verbal communication skills.

+ Microsoft Applications skills.

+ Ability to handle multiple projects in a dynamic environment.



**Nice-to-Have**



+ Experience in an Aseptic environment strongly preferred.

+ Experience in a 24/7 manufacturing facility preferred.

+ Work experience in a regulated environment (FDA, cGMP) preferred.

+ Knowledge and experience with Drug Product processing and equipment preferred.



**Physical/Mental Requirements**



+ Must be able to function under a stressful situation while focused at the necessary requirements.

+ Must be able to appropriately identify and escalate issues on a timely basis.



**Non-Standard Work Schedule, Travel, or Environment Requirements**



+ This role is primarily day shift, Monday - Friday. Flexibility to work outside of schedule work shift is needed to support 24/7 manufacturing (weekend, off-shift, holiday, and overtime) as business demands.

+ Must be able to work in an aseptic manufacturing environment (aseptic gowning).



**Other Job Details:**



+ Eligible for Employee Referral Bonus: YES

+ Eligible for Relocation Assistance: NO



\#LI-PFE



**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, Quality Assurance and Control

Categories

Posted: 2021-03-29 Expires: 2021-04-28

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Aseptic Process Engineer

Pfizer
Rocky Mount, NC 27804

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