Location:West Chester, Ohio, United StatesJob reference:
Nov. 17, 2016
At AstraZeneca we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. We’re focused on the potential of science to address the unmet needs of patients around the world. We commit to those areas where we think we can really change the course of medicine and bring big new ideas to life. As a Mechanic Technician - Filling in West Chester, Ohio, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives. Operations at AstraZeneca is a truly world-class business unit. It offers one of the most exciting, fast paced, challenging and rewarding work environments in the world of operations, supply chain and manufacturing.
Main Duties and Responsibilities
The Mechanical Technician is a direct labor position reporting to a Process Execution Team Process Facilitator on the Manufacturing floor, which supports operations. This position will require working in various Controlled/Non-Classified areas. The Technician operates equipment, performs in- process monitoring, line clearances, OEE data collection, cosmetic inspection and completes batch record entries in accordance with cGMPs.
Essential Job Functions:
- Perform cleaning and housekeeping activities for assigned areas as required to maintain a cGMP environment.
- Perform 5S activities and maintain organization of operating areas.
- Perform work requirements in a responsible manner, in accordance with SOPs, cGMPs and established safety procedures in accordance with OSHA requirements and guidelines. Be familiar with “Material Safety Data Sheets” for area chemicals.
- Perform batch record and GMP documentation entries. Maintain records and/or logs as required in performance of job responsibilities. This will include mathematical computation where needed.
- Knowledge of product security controls including controlled substance handling.
- Responsible for outgoing quality level.
- Some overtime will be required with prior notice to support business needs.
- Be able to start up and make minor adjustments to machinery.
- Computer on-line may require some data input. This includes SCADA and HMI entries.
- Perform the duties of operating assigned machinery consisting of servicing machines with materials, removing finished materials from machine tables, and assuring smooth flow of product.
- Perform visual and physical checks of in-process and finished materials as requested.
- Be familiar with job related hazards. Report all discrepancies to process facilitator.
- Perform all other duties with minimal supervision under the direction of the process facilitator or designee.
- Knowledge of light material handling equipment (non-motorized lifts).
- Perform inventory control and reconciliation activities, which may require use of SAP in a limited role.
- Work with various printing devices including printing mats, ink-jet, etc.
- OEE data collection either by manual method or knowledge of automated collection system.
- Certified OJT trainer activities on the team, as needed.
- Flexibility in cross training between packaging functions.
- Responsible for assembling, disassembling and sanitizing various packaging equipment.
- Familiarity with chemical handling and spill control procedures in connection with hazardous waste pick-up duties.
- Assist mechanical staff with preventive maintenance procedures, as required.
- High school graduate, vocational school graduate or equivalent
- 1 Year of experience in a pharmaceutical or cGMP regulated environment
- Must have the ability to effectively understand, read, write, communicate and follow instructions in the English language.
- Good attention to detail is required. Individual must be capable of keeping accurate records and performing mathematical calculations.
- Prior production experience
- Experience working in a LEAN manufacturing environment
- Knowledge of cGMPs and FDA policies/procedures
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.