Equipment & Process Technician II

Nature and Scope

The Equipment and Process Technician II 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 inspection area setup of automated equipment and manual inspection processes, labeling and packaging equipment and process duties, line clearances and assist with inspection/packaging schedule. The Technician will be responsible for maintaining inspection and packaging equipment for changeover and adjustments. In conjunction with the Supervisor, the Technician will provide input and assistance to other Departments as needed. The Technician plays a critical role in assuring safe, effective, and compliant activities are performed in the inspecting and packaging area and plays a critical role in maintaining production schedules. The Equipment and Process Technician II will be proficient in all activities associated with the inspection and packaging process and be able to work with minimal supervision. The Technician will receive direction, training, and mentorship from the Supervisor of Inspection and Packaging. The Technician will, with assistance from the Supervisor, be able to troubleshoot minor equipment adjustments and repairs during setup and during operations. The Technician will be able to select parameters requiring Supervisor Approval from some manufacturing technologies using the HMI-PLC/SCADA control/data systems.

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 and program automated Inspection and Packaging equipment with little to no assistance.
• Physically performs inspection, packaging, changeover, cleaning and provides documentation oversight for all such activities.
• Physically performs inspection and packaging reconciliation and provides documentation oversight and acknowledgement for such activities.
• Assists with training of new personnel within the department.
• Ability to mentor other Technicians in all facets of the inspection process.
• Ability to assist the Supervisor in the planning of inspection and packaging activities on a daily, weekly and long-term schedule.
• Ability (in conjunction with Supervisor) to assign equipment, rooms, or personnel to meet required production schedule.
• Ability to troubleshoot any problems that might arise.
• Ability to review executed batch records and logbooks 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 workspace in a clean and orderly manner.
• 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 preferred. Technical Training or Bachelors’ Degree is a plus.
• Minimum 3 years’ experience in inspection, packaging, quality control and/or production preferred. Require/Preferred Experience with specific equipment/software/programs etc.
• Ability troubleshooting basic operations on automated inspection machines to include, jams, basic error codes, etc.
• Must be able to recognize visual trends in automated inspection process and elevate as necessary.
• 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 Requirements

• 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.
• 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.

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/fmlaen.pdf

• Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov)

• Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf

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