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 day shift (2-2-3 schedule)

The Technician, Bulk Diluent performs self-directed tasks related to the manufacturing of pharmaceutical products and provides specific technical expertise in the Diluent Department.

Essential Job Functions:

• Operate production equipment without supervision after certification.
• Create, revise, and assist with preparation of documentation regarding activities, actions, and/or results.
• Clean and sanitize equipment and components.
• Complete required training.
• Ensure proper documentation practices during production.
• Ensure that weights, measures, and raw materials are managed appropriately so that manufactured batches contain proper ingredients and quantities.
• Initiate batches in SCADA.
• Perform shift cleanings, including spot and more detailed cleanings.
• Perform visual inspections.
• Assist with troubleshooting and process improvement activities.
• Train others on equipment, machines, procedures, and/or processes.
• Gather, organize, and communicate operational information to others.
• Participate in spill control, handling of hazardous materials, and first aid.
• Use CMMS (Computerized Maintenance Management System) to manage logistics.
• Use SAP to track inventory and materials.
• Provide leadership, development, and mentoring for others.
• Identify temporary and permanent fixes to address issues.
• Monitor production area to ensure compliance with regulatory requirements.
• Review completed production documentation (for example: batch records, log books, etc.) for quality, completeness, and cGMP compliance.
• Alert others (for example: supervisor, manager) when problems occur outside of SOPs (Standard Operating Procedures).
• Attend team meetings to discuss progress, initiatives, and/or other matters.
• Monitor equipment for performance and problem indicators.
• Participate in daily shift change meetings.
• Read, understand, and comply with cGMP (Good Manufacturing Practices) and SOPs (Standard Operating Procedures), including general safety, lock outs, etc.
• Wear sterile garments and PPE (Personal Protective Equipment) as required by specific activities.
• Perform preventative (scheduled) and corrective (unscheduled) maintenance of production equipment without supervision.
• Ensure proper documentation practices during maintenance processes.
• Perform, in order of priority, work required in response to process equipment requests received through the Work Request System.
• Read and interpret diagrams, drawings, and other schematics.
• Recommend and initiate activities to ensure area and equipment is maintained in a state of compliance.
• Conduct process checks to ensure that processes are operating within required parameters.

Other Duties:

• Complete duty-based packets by reading SOPs (Standard Operating Procedures) and excerpts from technical documentation.
• Write, review, and revise SOPs, work instructions, and MBRs (Master Batch Records) for cGMP (Good Manufacturing Practices) manufacturing of commercial product.
• Read technical publications and manuals, and write associated procedures.
• Assist with executing validation protocols for processes and/or equipment.

Minimum Requirements:

• High school diploma or GED required
• 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.

Preferred Background:

• Prior production experience
• Experience working in a LEAN manufacturing environment
• Knowledge of cGMPs and FDA policies/procedures

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.