Job Details

  • Title: Process Development Technician
  • Code: RCI-PFE-16640-1
  • Location: Andover Massachusetts (MA) 01810
  • Posted Date: 09/11/2019
  • Duration: 12 Months
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  Job Description

1st shift: Mon-Fri (7:00am-3:30pm)

ROLE SUMMARY

The Process Technician drives the execution of Commercial, Clinical, and/or Development production according to Standard Operating Procedures and Production Schedule. The 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
  • BE (preferably chemical engineering) and 0-3 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.