28 days old

Tech Asso, Clinical Manufacturing, Production Support

Pfizer
Andover, MA 01810
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**ROLE SUMMARY**

The clinical manufacturing production support associate technical specialist 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 media & buffer formulation, Clean Out of Place (COP) & autoclave operations, and weighing and dispensing of raw materials to support Production Support operations.



**ROLE RESPONSIBILITIES**



+ Support execution of solution formulation and Weigh/Dispense operations in a GMP environment

+ Support equipment set up, CIP, SIP, Clean Out of Place (COP)/Offline Parts Washing and Autoclave operation

+ Support troubleshooting of production support equipment and operations

+ Performs routine standardization and functional checks for process instrumentation for daily use in production

+ Completes work instructions and maintains clean room environment to comply with regulatory requirements

+ Supports material handling activities, including picking of materials to GMP manufacturing facility and finished product from production to interim storage (cold and frozen storage).

+ Works on routine assignments per written procedures with guidance from senior associates.

+ Adheres to good manufacturing practices and standard operating procedures, and material sampling instructions.

+ Maintains a safe work environment.

+ Completes GMP forms and/or batch records as required for material receiving, shipping activities.

+ Effectively uses process automation systems (i.e. Delta V and OSI/Pi Historian) and supporting business systems (i.e. Microsoft Dynamics/SAP/ERP Systems, Trackwise, Document Management Systems, Microsoft Sharepoint etc.).

+ Reviews work throughout the process and at completion, in order to ensure that it has been performed properly.

+ Supports planning/organization of work to ensure that activities are performed effectively, and to respond to fluctuating workloads.

+ Cross-functional communication with technology transfer teams, lab scientists, supply chain, quality and engineering as necessary

+ Engages in and supports culture of continual improvement through ownership of improvement for work processes, equipment and safe work environment. Advises Shift supervisor on improvements which may optimize work processes.



**BASIC QUALIFICATIONS**



+ HS diploma, Associates Degree, or BS/BA in Biotechnology, Microbiology, Cell Biology, Chemical Engineering, Biochemistry or equivalent.

+ Requires a minimum 0-3 years of experience in a biotechnology manufacturing or laboratory environment.



**PREFERRED QUALIFICATIONS**



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

+ Understanding of solution preparation unit operations, operation of production support equipment and/or inventory management desired.

+ Familiarity with Production Control Systems (i.e. DeltaV), ERP Systems (i.e. Microsoft Dynamics and/or SAP) and other business systems (Document Management Systems, LIMS, Microsoft Word, Excel, etc.)

+ Familiarity with Quality Management and Change Management Systems (i.e. Trackwise)

+ Ability to follow Standard Operating Procedures and work under minimal supervision.

+ Fundamental mechanical aptitude and ability to interface with computerized systems required.

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

+ Excellent oral and written communication skills.



**ADDITIONAL OFFER DETAILS**



+ **Last Day to Apply: November 15, 2019**

+ Additional Location Information: Andover, MA

+ Eligible for Employee Referral Bonus: Yes



**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.



**\#LI-PFE**



Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Posted: 2019-10-16 Expires: 2019-11-16

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Tech Asso, Clinical Manufacturing, Production Support

Pfizer
Andover, MA 01810

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