What are the responsibilities and job description for the Manufacturing Technician III position at VALIDATION ASSOCIATES LLC?
Summary : The Manufacturing Technician III will work directly with a range of technologies. Dependent
upon assignment, the range of technologies exposed to will be :
Essential Functions :
Upstream Unit :
Single-Use Cell Culture Vessels / Bioreactors up to 2000L
Bacterial Fermentation Culture Vessels up to 2000L
Alpha Wasserman Continuous Flow Centrifuge
Disposable Magnetic Mixing Bags and Totes
Cell Expansion and Propagation
Banking / Cryopreservation of Cell Lines and Viruses
Hyperstack, Cellstack, and other Adherent Cell Technologies
Plate counting, microscopic examination
Monitor cultures, take samples, turn-around of bioreactor and fermenters, sterilization, and inoculation
Downstream Unit :
Medium to Large-scale filtration systems including Tangential Flow Filtration (TFF),
Hollow Fiber Tangential Flow Filtration (HFTFF), Nanofiltration and depth filtration
Medium to Large-scale Chromatographic systems (ÄKTA).
Pre-Packed Columns from 1L to 100L
Single use mixing systems (Pall & GE)
Single Use connectivity types such as GE DAC and Colder AseptiQuik
Bulk filling
Aseptic process simulation and drug product filling
Buffer Preparation Unit :
Preparation of medium from stock raw materials including the compounding, mixing, testing and filtration for further process needs
Preparation of buffers from stock raw materials including the compounding, mixing, testing and filtration for further process needs
Weighing of raw materials per batch record specifications and assignment of appropriate expiry per procedures
Integrity testing of filters
Essential Functions Include :
Write and review standard operating procedures, buffer formulation records and batch production records.
Assist senior staff in implementing project safety and quality assurance programs in
accordance with SOPs.
Maintain the confidentiality of proprietary company information.
Document and maintain activity records according to cGMP regulations and ensure junior team members are trained.
Operate general production equipment such as Autoclaves, Glass washers, Incubators, Analytical Scales, pH / conductivity meters, etc.
Perform daily cleaning and sanitization of the laboratory and manufacturing areas.
Maintain an effective working relationship with others.
Perform all other duties as assigned.
Required Skills & Abilities :
Excellent oral and written communication skills, interpersonal and organizational skills.
Proficient with Microsoft Office applications.
Excellent leadership skills.
Ability to train others to perform to cGMP standards.
Good self-discipline and attention to detail.
Must be able to work flexible work hours, and be willing to work outside of normal, scheduled hours; as necessary. Must be able to work alternative shift hours to include night shift hours and weekends as required.
Excellent math and computer skills.
Experience working in a cleanroom environment with full clean room gowning and good aseptic technique.
Must have good planning and time management skills and be willing and able to interface with colleagues in many different roles and functions throughout the manufacturing facilities.
Working Conditions & Physical Requirements :
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 regularly required to :
Experience prolonged standing, some bending, stooping, pushing, pulling, reaching above
shoulders and stretching.
Hand-eye coordination and manual dexterity sufficient to operate a keyboard,
photocopier, telephone, calculator, and other office equipment.
Potential for exposure to hazardous chemicals, gases, fumes, odors, mists, and dusts, and
other hazardous materials.
Ability to wear personal protective equipment including safety glasses, lab coat, safety
shoes and gloves.
Ability to lift / push / pull up to 25 pounds frequently and up to 50 pounds occasionally.
Attendance is mandatory.
Minimum Qualifications :
Bachelor’s degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or other related field with one (1) year of relevant manufacturing experience in GMP or regulated industry; OR
Associate degree / Technical certification in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or other related field with two (2) years of relevant experience, one (1) of which should be in manufacturing, GMP or regulated industry; OR
High School / GED with four (4) years of relevant experience, two (2) of which should be in manufacturing, GMP or regulated industry.
Preferred Qualifications :
GMP experience
Biotechnology certificate preferred.
Cross training with other identified functional areas.
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