1+ months

Senior Associate Engineer, Clinical Manufacturing

Pfizer
Andover, MA 01810
**ROLE SUMMARY**

The clinical manufacturing operations engineer is part of a multi-disciplinary team responsible for cGMP production of phase I/II clinical drug substance supporting the Pfizer Biotherapeutics portfolio.



The successful candidate will be a part of a team responsible for the execution of downstream mammalian and microbial processes.



The role will support facility/equipment upkeep, testing, PCO/HCO activities, and functionality. Creation of necessary cGMP documentation, SOP revisions, batch record creation and review, as well as automation review. Oversight and execution of day to day operations and training of operations staff.



**ROLE RESPONSIBILITIES**



+ Execute and troubleshoot downstream purification processes in a cGMP environment. Includes support and troubleshooting of CIP and changeover operations.

+ Lead tech transfer activities for new products and product changeover for operations team

+ Authorship of and execution against SOP's for downstream unit operations

+ Lead/support the creation of manufacturing batch records and other cGMP documentation

+ Data analysis and communication/collaboration with tech transfer team, development labs and quality

+ Training of operations colleagues

+ Lead/support implementation of new technologies and equipment

+ Lead/support investigations and audits as needed



**BASIC QUALIFICATIONS**



+ BS/BA in Biotechnology, Microbiology, Cell Biology, Chemical Engineering, Biochemistry or equivalent

+ 4 to 6+ years of experience in a laboratory or manufacturing environment



**PREFERRED QUALIFICATIONS**



+ Prior experience in a Biological Pilot Plant, cGMP Clinical or Commercial Manufacturing setting

+ Hands on experience with harvest, chromatography, filtration , and final fill operations.

+ Experience with operation of single use systems

+ Experience with DeltaV, ERP Systems (i.e. axis360, SAP) and other business systems (Document Management Systems, trackwise, LIMS, Microsoft Word, Excel, etc.)

+ Ability to execute against SOP's and document entries in a compliant manner

+ Demonstrated capability to work as a team member in a matrix manufacturing team

+ Excellent oral and written communication skills

+ Ability to work under minimal supervision



**PHYSICAL/MENTAL REQUIREMENTS**



+ Must be able to climb flights of stairs, and remain standing for 1-2 hours

+ Must be able to lift up to 25 lbs



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



+ Ability to work off shift (Nights and Weekends) as needed; non-routine

+ Ability to work in a clean room environment



**Other Job Details:**



+ Eligible for Employee Referral Bonus: Yes

+ \#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.



Manufacturing

Categories

Posted: 2020-10-13 Expires: 2020-12-12

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Senior Associate Engineer, Clinical Manufacturing

Pfizer
Andover, MA 01810

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