Aseptic Technician II (11pm-7:30am)

American Regent, Inc.; Shirley (NY); On-site; USD 61,464 - 70,720; Full time

Job summary

American Regent, Inc. is seeking an Aseptic Technician II to perform setup, breakdown, repair and preventive maintenance of equipment used for conveying sterile containers and liquid filling of vials/ampules in an aseptic environment.

Candidates should have a high school diploma or GED and 2 years of cGMP manufacturing or sterile processing experience; strong reading of SOPs and basic hand-tool skills are required, with ability to work multiple shifts.

Qualifications

• High School Diploma or GED required.
• 2 years of relevant experience in a cGMP manufacturing environment or mechanical experience preferred.
• 2 years of sterile processing experience preferred.
• Ability to understand safety programs (e.g. Lock out / Tag out, line breaking).
• Basic use of small hand tools.
• Basic knowledge of pneumatics, solid state relays, and transformers, preferred.
• Basic knowledge of cGMP (Current Good Manufacturing Practices), preferred.
• Ability to follow instructions and document activities as outlined in SOPs
• Must be able to read documents in Standard English such as SOPs, maintenance schedules and operating manuals.
• Basic Microsoft Office and Windows skills.
• Flexibility to work multiple shifts and off hours during shutdown plus overtime.

Responsibilities

• Set up and break down of sterile liquid filling machines in an aseptic environment.
• Troubleshoot equipment and system issues.
• Perform preventive maintenance.
• Identify and correct unsafe conditions.
• Maintain PPE and safe working practices.
• Ensure proper change parts in fill rooms for setups.
• Maintain cleanliness of work area.
• Perform other duties as assigned by management.

Skills

SOP documentation

Reading English documents

PPE and safety practices

Documentation of activities

Flexibility for shift work

Education

High School Diploma or GED

2 years cGMP/manufacturing or mechanical experience

2 years sterile processing experience

Basic knowledge of safety programs (Lockout/Tagout)

Basic knowledge of hand tools

Tools

Hand tools

Pneumatics knowledge

Solid state relays and transformers knowledge

Job description

Nature and Scope

The Aseptic Technician II role entails the execution of setup, breakdown, repair, and preventive maintenance of equipment/systems used for conveying sterile containers and liquid filling of vials/ampules.

Essential Duties and Responsibilities

The Aseptic Technician II role entails the execution of setup, breakdown, repair, and preventive maintenance of equipment/systems used for conveying sterile containers and liquid filling of vials/ampules.

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.

• Set up and break down of sterile liquid filling machines in an Aseptic Environment.
• Troubleshoot equipment/system issues.
• Perform preventive maintenance.
• Identification and correction of unsafe conditions.
• Maintain Safety Expectations including use of proper Personal Protective Equipment (PPE).
• Ensure proper change parts in associated fill rooms needed for setups.
• Maintain housekeeping of own work area.
• Perform any other tasks/duties as assigned by management.

Education Requirements and Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.

• High School Diploma or (GED Equivalent), required.
• 2 years of relevant experience in a cGMP manufacturing working environment or mechanical experience, preferred.
• 2 year of sterile processing experience, preferred.
• Ability to understand safety programs (e.g. Lock out / Tag out, line breaking).
• Basic Use of small hand tools.
• Basic Knowledge of pneumatics, solid state relays, and transformers, preferred.
• Basic knowledgeable in cGMP (Current Good Manufacturing Practices), preferred.
• Ability to follow instructions and document activities as outlined in SOPs
• Must be able to read documents in Standard English such as Standard Operating Procedures, maintenance schedules and operating manuals.
• Basic Microsoft Office and Windows skills.
• Flexibility to work multiple shifts and off hours during shutdown plus overtime.

Physical Environment and Requirements

• Employees must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly.
• Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. PPE and Respirators are essential for the health and safety of employees.
• Must be able to occasionally lift up to 50 lbs. and stand for prolonged periods of time while fulfilling job duties.

Expected Hourly Rate:

$29.55-$34.00

The hourly rate displayed is the minimum and maximum hourly rate of compensation for the role that the employer in good faith believes to be accurate at the time of the posting of an advertisement for the role. Actual compensation for the role will be based on a number of different factors including but not limited to the candidate's qualifications, education, knowledge, skills and experience.

American Regent also offers a competitive total rewards package which includes healthcare, life insurance, profit sharing, paid time off, matching 401k as well as a wide range of other benefits.

American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.

Applicants have rights under Federal Employment Laws.

• FMLA poster: https://www.dol.gov/whd/regs/compliance/posters/fmlink.pdf
• Know Your Rights: Workplace discrimination is illegal (eeoc.gov)
• Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf

American Regent Inc. endeavors to make https://careers.americanregent.com/ accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email [e-mail].