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Process Development Technician II
Ref No.: 18-04183
Location: Herndon, Virginia

Job Title: Process Development Technician II
Location: One Burtt Road, Andover, MA 01810
Duration: 12 Months

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

ROLE RESPONSIBILITIES
Executes SOPs for unit operations (daily and long term). Includes CIP, SIP, and cleaning and sanitization of the facility
Operates buffer/media make-up tanks, glass washers, autoclaves, bioreactors, filtration equipment, inoculum preparation, chromatography skids, and UF/DF skids with varying mixes of automation and paper SOPs involved.
Supports implementation of new technology for process execution and/or analysis.
Interacts across the asset to achieve production schedule.
Reviews documentation daily as well as perform data entry – Monitor, identify and communicate process and compliance trends real time.
Archives documentation according to established procedures.
Required to modify and/or create job-related documentation including MBRs, SOPs, MFRs, work requests and others.
Assist in inventory tracking, maintenance scheduling, and troubleshooting of mechanical equipment.
Provides support during audits and with audit observation closure.
Responsible for keeping training current.
Maintains a safe working environment
Thorough understanding of cGMP requirements and safety practices.
Employs Automated systems, enterprise systems, and available technology to execute work.
Engages in and supports a culture of innovation and sustainable improvement through ownership of improvement for work processes, equipment and environment.
Strives for Right first time execution through flawless execution and ownership of the process.

What is the minimum education experience required?:
QUALIFICATIONS
• High School diploma and 4 years of relevant experience 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.

If Yes, how many hours of overtime (on average) per week?: 5

What will the resource be working with, or, have exposure to?:
  • Biohazardous Agent work (such as menigiditis, staph aureus, Lenti Virus, streph pneumoniae)
Job Title: Process Development Technician II
Location: One Burtt Road, Andover, MA 01810
Duration: 12 Months

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

ROLE RESPONSIBILITIES
  • Executes SOPs for unit operations (daily and long term). Includes CIP, SIP, and cleaning and sanitization of the facility
  • Operates buffer/media make-up tanks, glass washers, autoclaves, bioreactors, filtration equipment, inoculum preparation, chromatography skids, and UF/DF skids with varying mixes of automation and paper SOPs involved.
  • Supports implementation of new technology for process execution and/or analysis.
  • Interacts across the asset to achieve production schedule.
  • Reviews documentation daily as well as perform data entry – Monitor, identify and communicate process and compliance trends real time.
  • Archives documentation according to established procedures.
  • Required to modify and/or create job-related documentation including MBRs, SOPs, MFRs, work requests and others.
  • Assist in inventory tracking, maintenance scheduling, and troubleshooting of mechanical equipment.
  • Provides support during audits and with audit observation closure.
  • Responsible for keeping training current.
  • Maintains a safe working environment
  • Thorough understanding of cGMP requirements and safety practices.
  • Employs Automated systems, enterprise systems, and available technology to execute work.
  • Engages in and supports a culture of innovation and sustainable improvement through ownership of improvement for work processes, equipment and environment.
  • Strives for Right first time execution through flawless execution and ownership of the process.

What is the minimum education experience required?:
QUALIFICATIONS
• High School diploma and 4 years of relevant experience 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.

If Yes, how many hours of overtime (on average) per week?: 5

What will the resource be working with, or, have exposure to?:
  • Biohazardous Agent work (such as menigiditis, staph aureus, Lenti Virus, streph pneumoniae)


Regards,

Sanjai Kumar
Scientific Recruiter

13454 Sunrise Valley Drive, Suite 120, Herndon, VA 20171
Direct: (703) 889-6799 | Fax: (703) 889-6500
SanjaiK@LanceSoft.com | www.LanceSoft.com
Contingent Workforce | Enterprise Solutions | Engineering Services

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