Pfizer Senior Process Technician in Andover, Massachusetts

ROLE SUMMARY

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

ROLE RESPONSIBILITIES

  • Executes 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.

  • Executes the implementation of SOPs for unit operations including but not limited to, CIPs, SIPs, Sanitization, etc.

  • Implements the execution and issue resolution associated with process equipment commissioning, qualification and validation.

  • Drives troubleshooting, technical support/analysis and resolution of equipment, automation, and process issues on the manufacturing floor.

  • Drives for Right first time execution, the timely review of daily documentation and executes data entry; Monitor, Identify and/or Communicate process and compliance trends in real time.

  • Supports the assigned audit lead for walkthroughs/GMP100s and observation improvements.

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

  • Collaborates with the Subject Matter Expert for manufacturing operations in support of QTS investigations and CAPA implementations.

  • Responsible for remaining current and reviews curriculum for training programs in support of manufacturing processes.

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

  • Collaborates with cross-functional manufacturing assets in support of manufacturing campaigns.

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

  • Ensures work requests are generated when issues arise with manufacturing equipment.

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

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

QUALIFICATIONS

  • High School diploma and 2 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

  • 1st shift 6am - 6pm, rotating

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.

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.

Other Job Details:

  • Last Date to Apply for Job: July 26, 2018

  • Eligible for Employee Referral Bonus

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.