Aseptic Operator II

Work Schedule

Environmental Conditions

Job Description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

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

Job Description

Job Title: Aseptic Technician

Location/Division Specific Information:

Ridgefield NJ Pharma Division. Pre Fill Syringes

As part of the Thermo Fisher Scientific team youll 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 worlds 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 HMIs 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 wheelsand 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.

Education:

High school diploma or equivalent education required.

Required Experience:

1 year experience in manufacturing warehouse and/or cGMP experience

Physical Requirements / Work Environment:

Move transfer carts in and out of manufacturing area

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

What We Offer:

Compensation

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

Compensation and Benefits

This position may also be eligible to receive a variable annual bonus based on company team and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on which includes:

• A choice of national medical and dental plans and a national vision plan including health incentive programs

• 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

For more information on our benefits please visit: