1+ months

Sr Process Engineer/Scientist

Pfizer
Andover, MA 01810
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**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**



The senior Scientist/Engineer's primary focus is to maintain and execute technical programs supporting raw materials and single-use components and extractable and leachable. The senior scientist/engineer represents site at co-development team on technology transfer and control strategy development pertaining to raw materials and disposables. The senior scientist/engineer provides technical analysis and support associated with raw materials and single-use components and the associated analysis of elemental impurities, residual solvents and leachable/extractable profiles. This role will also support lifecycle product/process initiatives such as regulatory query response, technical support for investigations, validation and qualification programs supporting new product process validation and licensed process maintenance.



**How You Will Achieve It**



+ Technical lead for technology transfer associated with raw materials and single-use components

+ Technical lead for quality risk management on raw material and disposable applications

+ Conduct Extractable and Leachable Risk Assessment effort for new products

+ Technical Support for RM/Disposable investigations

+ Technical Support for RM/Disposable Change/Lifecycle Management

+ Regulatory Submission Authoring and Query Response on RM/Disposable related contents

+ Support determination of applicable QC test methods to include in release testing

+ Manage the leachable/extractable program for late phase/commercial products

+ Manage the raw material/component risk assessment and categorization program for all new and existing raw materials and components

+ Support product/process lifecycle efforts as needed

+ Technical support for validation and qualification programs supporting new product process validation and licensed process maintenance.



**Qualifications**



**Must-Have**



+ Bachelor's Degree in science or engineering discipline

+ 5+ years of experience

+ Demonstrated leadership and technical capabilities

+ Experience working with Supply operations, as well as enabling functions, managing and leading projects to meet agreed deadlines, including regulatory submissions to support new products

+ Strong written and verbal communication skills



**Nice-to-Have**



+ Master's degree in science or engineering discipline

+ Relevant pharmaceutical experience

+ Strong biochemistry background

+ Understanding of biological / vaccine requirements

+ Practical experience in facilitating and conducting risk assessments



**Other Job Details:**



Last Date to Apply for Job: April 1st, 2022



\#LI-PFE



**Pfizer 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 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
Posted: 2022-05-02 Expires: 2022-07-07
Sponsored by:
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Sr Process Engineer/Scientist

Pfizer
Andover, MA 01810

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