Equipment & Process Technician I

American Regent, Inc.; New Albany (OH); On-site; USD 38,000 - 46,000; Full time

Job summary

American Regent, Inc. is seeking an Equipment and Process Technician I to support the inspection and packaging of sterile pharmaceuticals in accordance with cGMPs.

The role emphasizes manual inspection, setup of automated equipment, labeling and packaging tasks, line clearances, and maintaining accurate records while meeting production schedules. The incumbent should have a high school diploma or GED (some college/technical training a plus) and at least 1 year of related experience in

Qualifications

• Requires ability to read and follow SOPs and operating procedures.
• Must be able to work with minimal supervision.
• Strong organizational and written communication skills.
• Proficiency in basic math including averages and percentages.

Responsibilities

• Physically performs inspection and packaging activities per procedures.
• Maintains accurate records and training logs.
• Sets up manual inspection with minimal assistance.
• Performs inspection, packaging, changeover, cleaning and documentation oversight.
• Reviews batch records/logs before final Production review.
• Supports Quality Assurance as needed and adheres to safety policies.

Skills

Inspection/packaging

Independent work

Communication skills

Mathematical skills

SOP reading

Education

High School diploma or GED

Some college or technical training

Job description

The Equipment and Process Technician I works with the Inspection and Packaging Supervisor in the activities associated with the inspection and packaging of sterile pharmaceuticals in accordance with company procedures and cGMPs. The incumbent meets inspection and packaging schedules while maintaining accurate records and professional behavior within the inspection/packaging areas. The Technician will perform manual inspection and train in the automatic inspection/packaging area for setup, of automated equipment and manual inspection processes, labeling and packaging equipment duties, line clearances and assist with inspection/packaging schedule. In conjunction with the Supervisor, the Technician plays a critical role in assuring safe, effective and compliant activities are performed in the manual inspection process while maintaining production schedules. The Equipment and Process Technician I will be proficient in all activities associated with the inspection process and be able to work with minimal supervision. The Technician will receive direction, training and mentorship from the Supervisor of Inspection and Packaging.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
• Physically performs inspection and packaging activities as defined by established operating procedures and as directed by Manager/Supervisor.
• Maintains accurate and complete records.
• Maintains an accurate and complete Training Record.
• Ability to set-up Manual Inspection process with little to no assistance.
• Physically performs inspection, packaging, changeover, cleaning and provides documentation oversight for all such activities.
• Physically performs inspection reconciliation and provides documentation oversight and acknowledgement for such activities.
• Ability to review executed batch records and log books prior to submitting for final Production review.
• Provides accurate and complete assistance to Quality Assurance as needed.
• Works in a safe and effective manner.
• Identifies and reports unsafe and non-compliant conditions.
• Maintains work space in a clean and orderly manner.
• Perform any other tasks/duties as assigned by management.
• We all must embrace the QUALITY culture.

QUALIFICATIONS AND REQUIREMENTS

• High School diploma or GED preferred. Some college or technical training is a plus.
• Minimum 1-year work experience in inspection, packaging, quality control and/or production preferred.
• Must be able to work independently, completing assigned tasks with limited supervision.
• Proven mathematical skills including addition, subtraction, multiplication, division, calculation of averages and percentages.
• Excellent organizational, interpersonal and communication skills (oral and written).
• Ability to take feedback constructively and consider the viewpoints of others.
• Must be able to read documents in Standard English such as Standard Operating Procedures, maintenance schedules and operating manuals.
• Ability to work overtime as needed.

PHYSICAL ENVIRONMENT AND PHYSICAL REQUIREMENTS

• Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves. PPE is essential for the health and safety of employees.
• Specific vision requirements include 20/20 near vision (can be corrected with eyeglasses or contacts) and color vision.
• Employee must be able to occasionally lift and/or move up to 50 pounds.
• Must be able to sit for extended hours, focusing and concentrating on items being inspected.

We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

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.

If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email [e-mail].

Our values define who we are. They are the fundamental beliefs of our organization and guide our actions and behavior. They influence the way we work with each other, the way we serve our clients, and the way we engage with our communities. Supporting patient health and enhancing the quality of life for animals are our guiding principles. Our promise is to provide the healthcare marketplace with a steady supply and broad portfolio of branded and generic specialty injectables. American Regent, Inc., a Daiichi Sankyo Group Company, is a top-10 injectable manufacturer. For over 50 years, we have been developing, manufacturing, and supplying high-quality generic and branded injectables for healthcare providers and veterinarians across the United States and Canada. For 20 years, American Regent has been a leader in IV iron therapy and we supply two of the top-selling brands in the US today. For over 30 years, we have supplied the leading joint health products for horses and dogs. We have locations in New York, Ohio, and California and sales territories nationwide.