- Title: Process Technician
- Code: RCI-19508-1
- Location: Andover Massachusetts (MA) 01810
- Posted Date: 09/25/2020
- Duration: 9 Months
- Name:Ankit Shah
- Email: Ankit.Shah@rangam.com
- Phone: 908-704-8843 ✖ 210
• Shift start and end time may be staggered across a shift team to provide wider coverage across the operational day, and also may vary from those times listed below.
• 1st shift 8am – 4:30pm, Monday - Friday
• 2nd shift 3:30pm – 12:00am, Monday – Friday
• 3rd shift 12:00am – 8:30am, Monday - Friday
• Rotating A/B 1st Shift and 2nd Shift may also be required during startup and training or as needed.
• Off-shift coverage may be required.
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.
• 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.
• High School diploma and 2+ years of relevant experience required.
• Experience in a GMP manufacturing environment is desired.
• Familiarity with SAP, LWLIMS
• 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.
• 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.