Manufacturing Technician

Job Description

Essential duties/Responsibilities :

• Experience with aseptic gowning procedures, cleanroom behaviour, and aseptic technique when handling all product-contact components.

• Experience with TFF, UF, or Dia filtration, 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 Logbook

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.

Supervisory Responsibilities:  

None at this time

Language, Mathematical, and/or Reasoning Ability:

• Perform other duties as assigned

• 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:

• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• 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.

Qualifications

• 2-6 years of Aseptic/GMP Manufacturing Experience 

Additional Information

Warm Regards,

NIMISHA DROACH

Tel: (732) 549 2030 x 226

http://www.irionline.com