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

American Regent, Inc.; Shirley (MA); On-site; USD 4,071,000 - 4,684,000; Full time

Benefits offered by this job

Healthcare

Life insurance

Profit sharing

Paid time off

401k matching

Broad benefits

Job summary

American Regent, Inc. is seeking an Aseptic Technician II to set up and break down sterile filling equipment, troubleshoot line issues, and perform preventive maintenance in an aseptic environment.

Role requires following SOPs, maintaining safety and PPE standards, and documenting activities; flexibility for shifts and overtime is expected. Company offers healthcare, 401k, and broad benefits as part of total rewards.

Qualifications

• High School Diploma or GED required; ability to understand safety programs and SOPs.
• 2 years of relevant manufacturing or mechanical experience preferred.
• Experience with sterile processing and cGMP environments preferred.

Responsibilities

• Set up and break down sterile filling machines in an aseptic environment.
• Troubleshoot equipment and perform preventive maintenance.
• Identify unsafe conditions and ensure proper PPE usage.
• Maintain housekeeping and proper change parts for fill rooms.
• Follow SOPs and document activities accurately.

Skills

cGMP familiarity

Safety program knowledge

Reading SOPs

Basic PPE usage

Basic hand tools

Education

High School Diploma or GED

Tools

Pneumatics

Solid state relays

Transformers

Gowning procedures

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.

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