Manufacturing Technician

Manufacturing Technician III

Position Details:

Job Title: Manufacturing Technician Level 2 or Level 3

Location: South Plainfield, New Jersey

Duration: Permanent

Job Duties, Responsibilities, Qualifications, and Requirements

Job Summary: Manufacturing Technician Level 2 or Level 3

Essential Duties And Responsibilities:

• Experience with aseptic gowning procedures, cleanroom behavior, and aseptic technique when handling all product-contact components.
• Experience with TFF, UF, or Diafiltration, either at the bench scale or large scale.
• Experience with large scale buffer, media or solution preparation, encompassing weigh & dispense, buffer preparation, transfer and aseptic filtration.
• Experience reviewing standard operating procedures, batch records, GMP Logbooks

Recommended:

• Experience working in GMP manufacturing within a late-stage clinical or commercial environment.
• Experience working with process automation, electronic batch record and process skid PLC programming.
• Experience working in aseptic fill/finish, filling isolators.
• Experience working with single use manufacturing consumables such as bags, tube sets, bioreactors, columns and process manifolds.
• Experience authoring standard operating procedures, batch records and working in GMP document generation/life cycle management.
• Experience working towards the qualification of aseptic manufacturing processes in preparation for late-stage clinical and commercial phases/launch.

Education and/or Experience: 2-6 years of Aseptic/GMP Manufacturing Experience

Language, Mathematical, and/or Reasoning Ability:

• Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.
• Ability to write routine reports and correspondence.
• Ability to speak effectively before groups of customers or employees of organization.
• Ability to apply concepts of basic algebra and geometry.
• Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
• Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
• Ability to communicate in a high pressure environment.

Physical Demands:

• While performing the duties of this job, the employee is frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms; and talk or hear.
• The employee is occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl.
• The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds.
• Specific vision abilities required by this job include close vision, and ability to adjust focus.
• In the performance of the duties of this job the employee is required to travel (frequency), drive a motor vehicle, communicate using telephone and e-mail.