Main Purpose of the Position:
Under the direction of the Process Unit Lead or Lead Technician, perform a wide variety of tasks and operations that are required to fill, inspect and package sterile pharmaceutical products in a state-of-the-art, automated production and packaging facility. Troubleshoot, maintain, and assemble all production equipment as required. Assist Engineers and Maintenance Mechanics on major equipment overhauls, repairs, and installations as necessary. All operations will be carried out in compliance with cGMPs, Standard Operating Procedures (SOPs), product recipes, and Genentech standards.
- In addition to performing the responsibilities/tasks below, the successful candidate will need to demonstrate the following traits and capabilities:
- Passion and drive to develop and maintain a culture of continuous improvement, dedicated to providing the best results for our internal and external customers.
- Embraces Lean Manufacturing/Six Sigma tools (e.g., 5S, Kaizen) and leverages data analytics of system performance to identify opportunities for improvement and deliver reduced costs and increased efficiency.
- Collaborates with Cross-Functional teams (Quality, Engineering, Assets) to pilot new process enhancements.
- Actively participates in a teamwork environment that maintains a high performance culture.
- Strictly adhere to Good Documentation Principles (GDP's), and the ability to accurately complete Batch Production Records (BPRs), logbooks, and forms to maintain a high level of data integrity.
Responsibilities:
- Adhere to all plant safety policies and procedures and proactively identify unsafe conditions.
- Assist in cleaning, set up, change over, and running of equipment for the inspection or packaging of various-sized vials, pre-filled syringes, and devices as required.
- Supporting the Engineers, Maintenance Mechanics, and/or outside services in the repair, maintenance, and calibration of GNE Systems as required. This includes executing user-performed and routine maintenance.
- Perform training of other Technicians, and assist in the development and improvement of HTO SOP's and training materials.
- Execute production recipes, check-in equipment, and perform material movements using automated computer software applications (SAP and MES systems).
- Prior to start-up, during processing, and at the completion of the manufacturing process, perform all documentation and clerical functions to provide the proper accountability and traceability of components and finished product.
- Responsible for identifying, reporting, and documenting process deviations or atypical events in accordance with site Standard Operating Procedures (SOPs)
- Knowledge of the automation systems that include SAP, Manufacturing Execution Systems (MES), PiProcess Book, Programmable Logic Controllers (PLC) and Human Machine Interfaces (HMI).
- Troubleshooting and identification of resolution for mechanical failures in production.
- Performing manual and semi-automated inspection of filled product vials with a focus on quality and efficiency.
- Conduct environmental monitoring activities in the manufacturing areas as required including routine cleaning and housekeeping activities to maintain environmental grade of each manufacturing area.
- At the start and finish of each shift, report and make recommendations regarding equipment, supplies, required repairs, process concerns, safety concerns, and areas for improvement in reliability, yield, and efficiency.
Qualifications / Requirements:
Proficiency in the English language- reading, writing, and communication. Must be able to work all shifts (Days, Swings), required overtime as needed, able to lift 45 pounds, and stand for extended period of time. Must be able to successfully pass all job-related tests and certifications required for working in a cGMP, quality environment including but not limited to: medical evaluations by on-site nursing staff for gowning into controlled non-classified and classified manufacturing areas, visual inspection qualification testing, and GMP requirements to perform essential functions of the job. Must re-qualify every year on all job-related tests and certifications as job or qualifications require. All candidates must pass a vision acuity and color discrimination test.
Education:
High school diploma or equivalent and two years of manufacturing experience in related industries (e.g. Aerospace, Automotive, Food and Beverage, or Semiconductor) OR
Graduate of a two-year Associates Degree program in Bioscience Technology, Microelectronics Technology, or similar
Experience:
2 to 5 years (within the last 7 years) experience in the operation of equipment used in the inspection and packaging of products/containers is highly desirable.
Computers:
Must be computer literate, including ability to interface with computer systems and PLC-based logic. Must be comfortable working with Microsoft suite (Word, Excel, PowerPoint), navigating through web pages and e-mail. Must possess basic typing skills.
Nesco Resource offers a comprehensive benefits package for our associates, which includes a MEC (Minimum Essential Coverage) plan that encompasses Medical, Vision, Dental, 401K, and EAP (Employee Assistance Program) services.
Nesco Resource provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
