Manufacturing Technician II
1125 Pleasant View Terrace, USNJ0001 Ridgefield, NJ
Operates general manufacturing equipment under close supervision in accordance with current GMPs or standardized procedures and within safety guidelines. Requires good documentation skills and attention to detail. Tasks to be completed may include fermentation, protein purification, solvent extractions, tissue culture, preparation of bulk solutions, aseptic fills of buffers, filling and labeling of vials under sterile and non-sterile conditions, routine buffer and media preparation, filtration, vial preparation and sterilization. Operates general manufacturing equipment in strict accordance with SOPs to complete tasks as noted above. Brings deviations in process protocols to supervisors’ attention. Maintains all associated documentation for operations being performed. Reviews and records physical inventory of stock items. Requires very few, if any of the requisite skills to perform the required tasks of the position at this level. Receives detailed instructions on all work. All activities are closely supervised, and work is reviewed upon completion. Receives general instructions on new work, which is generally reviewed upon completion. 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. Requires physical demands of lifting up to 30-35 pounds. The work environment characteristics described here are representative of those an employee to encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. May involve work with hazardous materials.
- 3 to 6 years
Perform routine daily and weekly cleaning of manufacturing area.
Will serve as witness of routine unit operation tasks for batch record signing. Maintains all associated documentation for operations being performed. Will be assigned formal FMEAs, RAs, CAPAs, CCRs, NCRs, and Action Items as needed.
Applies acquired skills while performing the most complex tasks of the position, following established practices and procedures. Demonstrated ability to apply experience to perform equipment troubleshooting, monitor employee activities and to make procedural revisions, as needed. Implements and maintains production schedules based upon intra-departmental information. Perform to ensure compliance with GMPs and SOPs.
Generally receives instructions on all assignments with some supervision. Takes initiative to identify issues, troubleshoot, propose solutions, and keep leads/ management informed.
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, majority of the work activities are performed while standing.
- Ability to offload product off carts and onto pallets; move transfer carts in and out of Manufacturing area
- Ability to stand over intervals of several hours at a time
- Ability to stand for longer periods, bend, squat, and reach
- Ability to lift, push or pull various amounts of weight
Based on production schedules, random and different start time scenarios may occur, so a very flexible work schedule is required for the candidate. Ability to accommodate production requirements that may require 50+ hour workweeks, including extended day hours and weekend. Core Work hours are 6 am to 2: 30 pm. This role requires frequent work on weekends depending on production demands.
- Prior document revision (SOPs and BPRs) experience and experience reviewing BPRs is preferred.
- Prior mechanical experience and experience working as an Aseptic Production operator is preferred.
- Typical minimum education and experience required is AA degree in related discipline and experience working in GMP environment is preferred.
Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws.In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.