6 days old

Master Process Technician (2nd Shift)

Pfizer
Andover, MA 01810
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**ROLE SUMMARY**

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



**ROLE RESPONSIBILITIES**



+ **Leads** 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.

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

+ **Point of Contact** **for** the execution and issue resolution associated with process equipment commissioning, qualification and validation.

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

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

+ **Attend and participate in weekly production schedule meetings.**

+ **Partners with the assigned audit lead for walkthroughs/GMP100s** and observation improvements.

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

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

+ Responsible for remaining current **and drives** **development of curriculum for** training programs in support of manufacturing processes.

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

+ **Collaborates** **with Quality, Engineering, Process Development, Validation and/or** **cross-functional** manufacturing assets in support of manufacturing campaigns.

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

+ **Generates** **work requests** when issues arise with manufacturing equipment.

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

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



**BASIC QUALIFICATIONS**



+ High School diploma and 5 years of relevant experience required.

+ Experience in a GMP manufacturing environment is desired.



**PREFERRED QUALIFICATION**



+ 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.



**PHYSICAL/MENTAL REQUIREMENTS**



+ Requires the moving of heavy equipment and the ability to lift ~50 pounds. The incumbent needs to take the necessary safety precautions when working with pressurized systems, steam, and corrosive chemicals.

+ The incumbent is required to attain detail knowledge of the operational equipment.

+ The incumbent will be required to solve problems regarding site assessment, specific units used in Biopharmaceutical manufacturing.

+ The incumbent must be able to express ideas into SOPs, MFRs and be able to use a multitude of programs including Excel, Word, Power Point, etc.



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



+ You will be required to work one of the following standard shifts. Note that shift hours and other requirements may fluctuate based on business needs.

+ Monday - Friday, 3:30pm - 12:00am

+ Rotating 3/2/2 schedule, 2:00pm - 2:00am

+ Off-shift coverage may be required.



**OTHER INFORMATION**



+ **Last Date to Apply for Job: 11.10.2020**

+ 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.



Manufacturing
Posted: 2020-10-14 Expires: 2020-11-14
Sponsored by:
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Master Process Technician (2nd Shift)

Pfizer
Andover, MA 01810

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