1+ months

Process Technician

Andover, MA 01810
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The incumbent will be responsible for execution of the Plasmids Gene Therapy manufacturing process in a multi-product cGMP facility capable of manufacturing commercial, clinical and development stage biologic products.

The **Process Technician** **supports** the execution of Commercial, Clinical, and/or Development production according to Standard Operating Procedures and Production Schedule. The **Process Technician** will work on interdisciplinary teams, to implement process improvements, participate in process troubleshooting.


+ **Supports** manufacturing operations on the production floor for buffer/media make-up tanks, glass washers, autoclaves, bioreactors, filtration equipment, inoculum preparation, chromatography skids and/or UF/DF skids with varying levels of automation.

+ **Supports** the implementation of SOPs for unit operations including but not limited to, CIPs, SIPs, Sanitization, etc.

+ **Supports** the execution and issue resolution associated with process equipment commissioning, qualification and validation.

+ **Assists** troubleshooting, technical support/analysis and resolution of equipment, automation, and process issues on the manufacturing floor.

+ **Strives** for Right first time execution, the timely review of daily documentation and **supports** data entry; Monitor, Identify and/or Communicate process and compliance trends in real time.

+ **Implements** any audit observation improvements.

+ **View Role** for controlled documentation; SOPs, Manufacturing Batch/Formulation Records, Forms, etc.

+ **Assists** the Subject Matter Expert for manufacturing operations in support of QTS investigations and CAPA implementations.

+ Responsible for remaining current on training programs in support of manufacturing processes.

+ Lean Manufacturing, Sustainability, Operational Excellence initiatives; facilitate the drive towards continuous improvement in all manufacturing areas.

+ **Interacts with** manufacturing asset in support of manufacturing campaigns.

+ in the escalation process through various levels of management when operations, personnel safety, equipment functionality, product supply and/or quality compliance are at risk.

+ **Escalates the need for work requests** when issues arise with manufacturing equipment.

+ **Adequate** in enterprise systems to support manufacturing operations including but not limited to, SAP, LIMS, AMPS, PDOCS and/or QTS.

+ **Assists** production sustainability through the performance of inventory accuracy, reconciliation and/or task prioritization to maintain metric adherence.


+ High School diploma required.

+ Experience in a GMP manufacturing environment is desired.


+ Familiarity and experience with either purification processes or mammalian cell culture.

+ Support operations (such as solution preparation and/or operation of autoclave/depyrogenation ovens) is not essential, but is highly desirable.

+ The ability to execute against SOP's and document entries in a cGMP compliant manner.

+ Ability to interpret and prioritize workflow to maintain the production schedule.

+ Effective verbal and written communication skills.

+ **Last Date to Apply for Job: 05.14.2020**

+ 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.

Posted: 2020-04-27 Expires: 2020-07-02
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Process Technician

Andover, MA 01810

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