Senior Engineer, Automation - West Chester, OH | Biospace
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Senior Engineer, Automation

AstraZeneca Pharmaceuticals LP

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Location:
West Chester, OH
Posted Date:
9/22/2017
Position Type:
Full time
Job Code:
R-013348
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

Location: West Chester,
Ohio,
United States
Job reference: R-013348

Posted date: Aug. 30, 2017

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 Senior Engineer, Automation in West Chester, OH, you’ll play a pivotal role in channelling 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

As the Senior Engineer, Automation, you will act in a leadership role in the execution of tasks related to the automation of equipment/systems for day to day manufacturing operations.
• Prepare documentation of activities, actions, and/or results.
• Read SOPs (Standard Operating Procedures) and excerpts from technical documentation.
• Complete required training.
• Ensure proper documentation practices during job activities.
• Conduct troubleshooting activities.
• Train others on systems, software, equipment, machines, procedures, and/or processes.
• Answer compliance and process questions from others.
• Communicate policies and procedures to employees.
• Establish visual tracking and other tools to enhance Audit readiness and trend analysis.
• Use CMMS (Computerized Maintenance Management System) to manage logistics.
• Communicate priorities and progress to team on a continuing basis.
• Analyze trends in data in order to provide accurate descriptions, identify root causes, and/or identify
solutions or improvements.
• Identify temporary and permanent fixes to address issues.
• Monitor key performance indicators to meet strategic goals.
• Review and approve documentation needed for qualification of equipment and processes.
• Write, review, and revise SOPs (Standard Operating Procedures) for maintenance of equipment, systems, and/or facilities.
• Facilitate and attend inter-departmental meetings to discuss matters involving the coordination of multiple departments.
• Interact with other departments to implementcorrective/preventative
actions.
• Manage the performance of others, including performance/merit reviews, professional development, and disciplinary action.
• Participate in cross-functional teams to meet strategic goals.
• Read technical publications and manuals, and write associated procedures.
• Review and approve OCMs, change controls, and document revisions.
• Attend team meetings to discuss progress, initiatives, and/or other matters.
• Collect, record, and report metrics.
• Read, understand, and comply with cGMP (Good Manufacturing Practices) and SOPs (Standard
• Operating Procedures), including general safety, lock outs, etc.
• Perform preventative (scheduled) and corrective/emergency (unscheduled) maintenance of equipment, systems, and/or facilities without supervision.
• Ensure proper documentation practices during maintenance processes.
• Read and interpret diagrams, drawings, and other schematics.
• Recommend and initiate activities to ensure area and equipment is maintained in a state of compliance.
• Assess and implement improvements in productivity, waste generation, quality and cost.
• Assist process engineering and managers with improvement projects.
• Lead committees or groups of employees tasked with accomplishing some objective(s).
• Consult cross-functionally as an SME (Subject Matter Expert) on systems and/or processes within a
functional area.
• Lead change control activities.
• Maintain accurate and complete records (for example: laboratory notebooks, quality records, sample
receipts).
• Coordinate the activities of third party personnel.
• Manage the design, implementation, and support of site-wide process automation, supervisory control,
and data acquisition (SCADA) solutions.
• Review and approve requirements, specifications, drawings, coding procedures, and guidelines.

Other Duties:
• Lead and coordinate investigations and studies with little supervision.
• Investigate deviations.
• Close out deviations, CAPAs, and/or pAFCAs as needed.
• Develop lean processes and procedures.
• Initiate appropriate action when process deviations occur.
• Interact with regulatory agency personnel during audits and inspections.
• Monitor records to ensure compliance with regulatory requirements.
• Perform quality audits to ensure devices used are in proper working condition
• Approve new and updated SOPs.
• Monitor equipment and/or systems for performance and problem indicators.
• Perform data entry.
• Report process deviations when they occur.
• Wear gowning, sterile garments, and PPE (Personal Protective Equipment) as required by specific
activities.
• Assist with executing validation protocols for processes, equipment, packaging, and/or cleaning.
• Conduct presentations (other than training) for different audiences.
• Create specifications for equipment.
• Evaluate new software and/or tools.
• Manage capital projects to ensure on-time and in-budget completion.
• Maintain archived records and documentation.
• Manage supplier activities during design, fabrication, installation, commissioning, and qualification.
• Perform factory acceptance tests.
• Provide 24/7 "on-call" support to others. Provide "off shift" support (for example: night shift support if you normally work day shift).
• Provide, verify, measure, and revise drawings.
• Recommend compliance resolutions to management.

Requirements

Essential Requirements
  • 4-year degree in Engineering, Computer Science or related discipline
  • 5-7 years of experience supporting manufacturing operations in a regulated environment
Desirable Requirements
  • Experience in automation, SCADA systems, software development
  • GMP experience
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.

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.

~bsp