Aseptic Operator II
About The Position
As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. A Day in the Life: Performs the tasks of the production operation specific to aseptic manufacturing and filling. Maintains batch record documentation and logs as required by corporation and regulatory agencies. Must be able to perform cleaning and sanitizing of production equipment and classified production space. Prepares equipment, filters, etc. required for production. Assists in process and system validation activities as required. Performs product sampling, environmental monitoring, or other related activities as directed. Performs routine tasks in the areas of Aseptic syringe filling. This includes but it is not limited to Operation of the HMI’s on automated syringe fillers, performing format part changeovers, bulk sampling, troubleshooting equipment issues, loading syringes into the filling machine or E-beam, manual weight checks, while monitoring critical parameters during operation. This job will also entail transfer of heavy vessels on wheels and autoclave racks on wheels. Perform routine daily and weekly cleaning of Aseptic and Classified manufacturing rooms. Serve as witness to routine unit operational tasks for batch record signing. Maintains all associated documentation for operations being performed. Demonstrated ability in the application of requisite skills and applies additional skills and acquired knowledge while following established practices and procedures. 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. Most of the work activities are performed while standing. 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 2nd shift or split shift hours, extended day hours and weekends. This role requires frequent work on weekends depending on production demands. Independently performs the tasks of the production operation specific to aseptic cleaning. Maintains batch record documentation and logs as required by corporation and regulatory agencies. Must be able to perform cleaning and sanitizing of production equipment and classified production space. Perform routine daily and weekly cleaning of Aseptic and Classified manufacturing rooms grade A-D. Serve as witness to routine unit operational tasks for batch record signing. Maintains all associated documentation for operations being performed. Demonstrated ability in the application of requisite skills and applies additional skills and acquired knowledge while following established practices and procedures. 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. The majority of the work activities are performed while standing. Move transfer carts in and out of manufacturing area Ability to stand over intervals of several hours at a time 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 extended day hours and weekends. This role requires frequent work on weekends depending on production demands.
Requirements
- High school diploma or equivalent education required.
- 1 year experience in manufacturing, warehouse, and/or cGMP experience
- Able to lift 40 lbs. without assistance
- Adherence to all Good Manufacturing Practices (GMP) Safety Standards
- Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
- Standing for full shift
- Ability to stand over intervals of several hours at a time
- Ability to 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 2nd shift or split shift hours, extended day hours and weekends.
- This role requires frequent work on weekends depending on production demands.
Responsibilities
- Performs the tasks of the production operation specific to aseptic manufacturing and filling.
- Maintains batch record documentation and logs as required by corporation and regulatory agencies.
- Must be able to perform cleaning and sanitizing of production equipment and classified production space.
- Prepares equipment, filters, etc. required for production.
- Assists in process and system validation activities as required.
- Performs product sampling, environmental monitoring, or other related activities as directed.
- Performs routine tasks in the areas of Aseptic syringe filling.
- Operation of the HMI’s on automated syringe fillers, performing format part changeovers, bulk sampling, troubleshooting equipment issues, loading syringes into the filling machine or E-beam, manual weight checks, while monitoring critical parameters during operation.
- Transfer of heavy vessels on wheels and autoclave racks on wheels.
- Perform routine daily and weekly cleaning of Aseptic and Classified manufacturing rooms.
- Serve as witness to routine unit operational tasks for batch record signing.
- Maintains all associated documentation for operations being performed.
- Demonstrated ability in the application of requisite skills and applies additional skills and acquired knowledge while following established practices and procedures.
- Independently performs the tasks of the production operation specific to aseptic cleaning.
- Perform routine daily and weekly cleaning of Aseptic and Classified manufacturing rooms grade A-D.
- Move transfer carts in and out of manufacturing area
Benefits
- Competitive Pay
- Performance Related Bonus where eligible
- Annual merit performance-based increase
- Excellent Benefits
- Medical benefits
- Paid Time Off/Annual Leave
- Employee Referral Bonus
- Career Advancement Opportunities
- Employee assistance and family support programs, including commuter benefits and tuition reimbursement
- At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
- Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
- Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
High school or GED
Number of Employees
5,001-10,000 employees
