AstraZeneca

Maintenance Technician

Positions are available for Monday-Friday 8 hours; 3 shifts

Are you ready to make a difference? As a Maintenance Technician at AstraZeneca, 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.

The AstraZeneca Newark Supply Site in Newark, DE, was established in 1971 and currently employs approximately 260 people. Over the course of these years, Newark has undergone many product portfolio changes since it first began as Stuart Pharmaceuticals through today as the designated AZ North America Packaging Center of Excellence and a Flexible Formulation site for the global supply of complex products. The site provides a collaborative environment where everyone feels comfortable and able to be themselves is at the core of AstraZeneca’s priorities. It’s important to us that you bring your full self to work every day. To help maintain your best self, here’s a sneak peek into some of the things this site provides for you: on-site fitness center access, lunch & learns, sustainable office working environment, team, site and family activities, life-long learning, diversity & inclusion, tuition reimbursement, and dining center.

OR BUSINESS AREA

The maintenance technician will work in the medicine formulation area, and will find equipment such as (Tablet Compressor, coating, Mills, Blender, Weighing, Fluid bed, HVACs) the area is divided into mini-factories, where each mini-factory has a production flow that goes from weighing, through granulation, compression and finally coating. each area is divided into a production area and a technical area, where a large part of the equipment controls are located, the mini-farms are also distributed over different floors.

What you will do:

Troubleshooting and repair operational problems with facility or production related equipment or systems.

Identification, installation and testing of instrumentation.

Define PLC input and output requirements for facility and production equipment and other control systems.

Document all changes made to validated control systems as required by SOP’s in SAP and MDT Prepare software documentation to support validation work.

Provide technical support for all phases of equipment and system validation.

Review electrical drawings associated with new equipment procurement.

Assist engineering personnel with the development of project specifications for new equipment. Act as technical liaison to contractor personnel who are performing activities on Site.

Support the site’s capital program by participating in the design, review installation, and qualifying activities associated with capital projects.

Support the compliance needs of the site by completing, and assisting others with, any required Change Control Documentation associated with Safety, Health, and Environmental or cGMP issues.

Support the sites improvement initiatives for changeover reduction, root cause investigation, and asset performance.

Responsible for the calibration of instrumentation: loops, controllers, recorders, transmitters, balances, and other devices used in pharmaceutical production. Parameters include, but are not limited to: temperature, pressure, weight, force and humidity.

Manage the site test instrument standards program.

Write and follow SOPs for the use, maintenance and calibration of instrumentation.

Must be able to work or be on-call as needed during other/off shifts and weekends when facility, production and/or equipment coverage is needed.

Create, review, and execute predictive maintenance plans, such as vibration analysis, thermography, etc.

Business As Usual activities

• Perform corrective actions on electrical and electronic systems in formulation equipment (Tablet Compressor, coating, Mills, Blender, Weighing, Fluid bed)
• Perform Preventive and Predictive Maintenance on equipment in the assigned areas including: Inspections, Calibrations, and scheduled overhauls
• Use analytical troubleshooting skills to recognize equipment problems, identify root cause, and recommend/ implement solutions that prevent problem reoccurrence.
• Perform mechanical and electrical equipment repairs in the assigned area including, routine adjustments and fabrication.
• Work with Supervisors, Operators, Engineers, and other Mechanics to identify and implement opportunities to improve equipment/production efficiencies
• Participate in cross-functional teams as assigned to support continuous improvement or equipment installation/modification
• Perform and document work in compliance with SOP’s, Safety Health & Environment (SHE) standards and Good Manufacturing Practices (GMP’s). To include: work orders, PM’s, logbooks, and permits
• Respond to multiple equipment/production problems and prioritize or change assignments as needed to meet formulation demands
• Must be able to work as needed during other shifts and weekends when production and/or equipment maintenance coverage is needed
• Participate in deviation investigations and help drive to root cause using tools such as 5- Why.

UNDERSTAND METRICS & SUPPLY

• Maintenance Downtime, MTBF and MTTR, Service Level Agreements (SLA), BackLog, maintenance plan compliance (MPC) metrics from the formulation area and support on actions to achieve the goals
• Able to interpret graphs and visual indications for metrics
• Elaborate SOPs, Work Instructions, One Lesson Points and other documents that will support the maintenance team, training the impacted team of mechanics.
• Assess the spare parts available for the maintenance
• Develop condition based maintenance and predictive maintenance solutions and implement.
• Organize and assess the documentations of the equipment, such as operation and maintenance manuals, electrical, pneumatic schematics, spare part lists, SHE procedures, quality procedures, and others.
• Active participation and engagement on equipment and process design, support the creation of the PM & AM strategy and documentation.
• Assist in the (re)qualification and (re)validation of processing equipment by supporting engineering in protocols and testing. As well as participates on factory acceptance test as per required.

TPM, RELIABILITY, LEAN KNOWLEDGE

• Understand and apply Lean concepts (5S, Standard Work, Problem Solving and others)
• Knowledge on Total Productive Maintenance (TPM) methodology, specifically on the Planned Maintenance and Autonomous Maintenance pillars, and train the operators, and mechanics on the methodology and activities.
• Support the operator to develop the AM activities of the TPM

Minimum Qualifications:

• A High School Diploma or G.E.D.

. Minimum of 3 years of relevant experience

• Good interpersonal, communication and writing skills
• Understanding and operational familiarity with PC/PLC control systems.
• Thorough familiarity with the analysis and repair of electrical/electronic control systems.
• Working knowledge of pneumatic systems.
• Understanding of concepts used in control system design and elementary programming is required.
• Three (3) years of maintenance experience in troubleshooting, installation, and repair of electrical/electronic system or an Associate’s Degree in a technical discipline and Three (3) years of maintenance experience in troubleshooting, installation, and repair of electrical/electronic system.
• One or more of the below qualifications as related to Instrument Calibrations:
• Successful completion of a post-secondary education program in metrology.
• Demonstrated calibration experience in a government regulated industry such as pharmaceutical, nuclear or aviation.
• Armed services experience and training in a calibration function
• Professional certification from a nationally recognized body such as the Instrument Society of America (ISA)
• Company sponsored instrument apprenticeship/qualification program.
• Demonstrated proficiency in all the following areas and certification/advanced training in at least 2 of the following:

o Mechanical maintenance o Electrical Maintenance o Instrumentation and Controls

• Strong organization, decision-making, judgment, and team-oriented skills are essential to manage multiple projects of variable complexity.
• Solid interpersonal skills are required in order to effectively communicate with all levels of the organization in various functional areas.
• Follow procedures in pursuit of high quality / safety standards
• Learn from mistakes / share lessons learned
• Accountability
• Collaborate with colleagues to achieve goals.

Preferred Qualifications:

• AAS in an Engineering Technology
• Pharmaceutical/ cGMP maintenance training and experience
• Experience in Reliability, TPM and Lean
• Preferred background includes a thorough familiarity with the analysis and repair of electrical/electronic control systems and a working knowledge of pneumatic systems. Familiarity with HVAC controls, formulation equipment (Tablet Compressor, coating, Mills, Blender, Weighing, Fluid bed), manufacturing and material handling equipment/systems is also desirable
• Strong background in mathematics and computer applications to include database management software and PLC/HMI operations

Why AstraZeneca:

At AstraZeneca, we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients, and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth, and development.

So, what’s next:

Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you!

Date Posted

07-Apr-2025

Closing Date

Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.

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