1+ months

Process Engineer, Tech Transfer

Pfizer
Andover, MA 01810
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**ROLE SUMMARY**

The **Process Engineer, Tech Transfer** role is accountable for operational representation and delivery of the elements associated with facility/equipment or process change.

This includes tech transfer of products/ processes to and from the facility, product re-entry, and changes to improve process robustness and facility capability.



**ROLE RESPONSIBILITIES**



+ Complete site assessment including process flow diagrams, equipment selection, material planning, and operations schedule for clinical and/or commercial products to be manufactured.

+ Act as the operations lead for incoming campaigns to and from the suites. This work includes interface with the donating or receiving organization and operations staff. It also includes technical oversight of campaigns.

+ Manage change to equipment, automation, and procedures in the manufacturing area.

+ Author and/or reviews manufacturing batch records, solution formulation records, and standard operating procedures.

+ Represent operations on cross functional projects to improve performance of the site.

+ Drive continuous improvement in the work processes associated with tech transfer, product entry to the manufacturing area, and change management.



**BASIC QUALIFICATIONS**



+ Bachelor's in engineering with 4 years of relevant experience is required.

+ or Master's in engineering with 2 years of relevant experience is required.

+ or Bachelor's in science with 6 years of relevant experience is required.

+ or Master's in science with 4 years of relevant experience is required.

+ Familiarity and experience with one of the following unit operations: mammalian cell culture/ bioreactor, centrifugation, tangential flow filtration, column chromatography.



**PREFERRED QUALIFICATIONS**



+ Hands on experience with the above unit operations at manufacturing scale

+ Previous experience in a GMP manufacturing environment

+ Previous experience with process validation, change management, tech transfer, or project management

+ Previous experience with scale up of the unit operations

+ Experience with Six Sigma, Method 1, 5S and/or other operational excellence programs



**PHYSICAL/MENTAL REQUIREMENTS**



+ Work will include walking throughout the manufacturing suite including up and down stairs.

+ An ability to cross reference multiple documents and perform a detailed review of documentation is required.



**NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS**



+ The role requires work in a GMP manufacturing suite which requires gowning.

+ The role requires occasional evening and weekend support of manufacturing operations.

+ Occasional travel may be required based on project assignment.



**Other Job Details:**



+ Last Date to Apply for Job: 11/30/2020

+ Eligible for Employee Referral Bonus

+ \#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
Posted: 2020-10-19 Expires: 2020-12-19
Sponsored by:
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Process Engineer, Tech Transfer

Pfizer
Andover, MA 01810

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