At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional skills with those of people from all over the globe.

Description:

12 Hour Night Shift Role

The Lead Technician is a direct labor position reporting to a Process Execution Team Process Facilitator on the Manufacturing floor, which supports Bulk/Diluent, Filling/Inspection, and Packaging operations. The position requires operating equipment in various classified/non-classified areas up to a Class 100 aseptic environment, performing in-process monitoring, product and environmental sampling, line clearances, OEE data collection and completing batch record entries in accordance with cGMPs. In addition, the Lead Technician will perform setup of equipment, execute training for Technicians, direct product and environmental sampling activities and perform batch reconciliation and accountabilities per 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.
• 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.
• Knowledge of light material handling equipment (non-motorized lifts).
• Perform inventory control and reconciliation activities, which may require use of SAP as needed within the team.
• Work with various printing devices including printing mats, ink-jet, etc. Perform set-up of print and embossing blocks for lot information and expiration dating.
• Perform OEE data entry and generate line reports as required for team review.
• Certified OJT trainer for PET job skills and functions.
• Working knowledge of automated and semi-automated inspection equipment.
• Particulate inspection qualification for a pre-determined population of the team.
• Schedule environmental sampling. Review environmental results and communicate trends to Process Execution Teams.
• Sterile gowning qualification for sterile core operators. Sterile core operators will also have an understanding of aseptic behaviors, media fills including line interventions, and have a basic knowledge of viable and non-viable monitoring equipment. This will include performing sampling both inside and outside the sterile core.
• Flexibility in cross training between functions.
• Follow batch and SOP instructions to perform in-process and finished product sampling.
• Label and deliver samples to appropriate locations.
• Perform required product attribute testing for product sampling and take appropriate actions based upon test results.
• Responsible for assembling, testing, disassembling, and sanitizing various equipment.
• Complete necessary critical site and batch specific microbiological sampling.
• Label microbiological sampling plates and deliver to specified locations.
• Familiarity with chemical handling and spill control procedures in connection with hazardous waste pick-up duties.
• Assist technical staff as required with preventive maintenance procedures.

Minimum Requirements:

• High school diploma or GED required.
• Minimum two years experience in a pharmaceutical production environment or other regulated manufacturing industry.
• 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.

 Preferred Background:

• Working knowledge of Microsoft applications, SAP, KRONOS, and Trackwise
• Experience working in a LEAN manufacturing environment
• Knowledge of cGMPs and FDA policies/procedures

Internal/External Contacts & Customers:

• PET staff

Required Competencies:

• Basic knowledge of sterile room techniques, chemical handling and usage
• Mechanical/technical aptitude              
• Ability to work effectively in a team environment
• Candidate should possess the ability to work in a changing/demanding environment

Reporting Relationship:

Direct Reports-0

Indirect Reports-0

Next Steps – Apply today!

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity.  If you know someone who would be a great fit, please share this posting with them.

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.