POSITION SUMMARY:
Manage the design, implementation and support for Plant-Wide Process Automation (PA) and Supervisory Control and Data Acquisition (SCADA) solutions within the Hamilton, OH facility to support pharmaceutical development and manufacturing. Manage activities of 3rd Party engineering firms and PA/SCADA consultants assigned to plant IT projects and deliverables.

ESSENTIAL JOB FUNCTIONS:
* Review and approve requirements, specs, drawings, coding procedures and guidelines; and oversight of implementation, commissioning, and validation of control systems.
* Coordinate with subject matter experts and development partners to align automation projects, resources and support activities with other site organizations and projects including Engineering, Operations, QA Validation, and QA Ops.
* Coordinate project activities with business owners, business partners, internal/external project team members and consultants.
* Consult as the subject matter expert on automation systems and processes within functional area.
* Ensure procedures, processes and SOPs are established and maintained for the design, development, validation and support of department solutions.
* Ensure solutions are compliant with FDA GxP validation including Part 11 and other regulations where appropriate.
* Work with the process engineering and development groups on developing and maintaining batch process recipes.
* Write, review and approve SOPs related to SCADA and Process Control systems.
* Train and coach manufacturing employees in the operation of new systems and processes.
* Execute programming changes to Rockwell PLC systems using RSLogix.
* Perform support, change control, and applicable maintenance of all systems. Configure Rockwell RSView SE software for HMI graphics and alarm changes.
* Initiate and maintain Process Control system infrastructure.
* Support projects and Systems Supported (including but not limited to):Automated aseptic filling lines; Automated bulk manufacturing lines; Automated utility control systems; Automated HVAC systems; SCADA/HMI systems and SCADA/Reporting systems.
* Apply knowledge and support for Good Automated Manufacturing Practices (GAMP5).
* Prepare protocols, reports, summary documents, equipment specifications and SOPS.
Requirements

Education
Minimum BS in Engineering, Computer Science, or related area.
Experience/Skills
* Prefer 5 yrs Experience within cGMP regulated industry preferably in pharmaceutical/biotech area. 5 years experience preferred in process automation and/or engineering.
* Hands-on ability to troubleshoot and install process automation equipment. Well-organized; can manage multiple assignments at a time. Effective written and verbal communication and presentation skills. Work independently and coordinate activities for various team members and stakeholders. Manage multiple tasks and projects simultaneously. Self-starter/self-motivated.
REQUIREMENTS:
Physical Demands
Ability to lift up to 40 pounds unassisted. Ability to work day or night shift. Up to 20% travel. On-call support
Manual Dexterity
Frequently use a computer keyboard, PDA or other electronic or laboratory equipment or devices.
Audible/Visual Demands
Ability to accurately interpret sounds and associated meanings at volume levels consistent with interpersonal or group conversations. Ability to interpret the letters and numbers when viewed on a personal computer screen, PDA, reports and other documents.
Environment
Office, Laboratory and Manufacturing environment
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled/Sexual Orientation Location OH, West Chester Category Manufacturing and Production Date Posted 5/15/2014 Req Number 14-50089210 Notice AstraZeneca does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on AstraZeneca's approved agency list. Unsolicited resumes or candidate information submitted to AstraZeneca by search/recruiting agencies not already on AstraZeneca's approved agency list, and who were not asked to work on a specific vacancy, shall become the property of AstraZeneca and if the candidate is subsequently hired by AstraZeneca, AstraZeneca shall not owe any fee to the submitting agency.   AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit www.astrazeneca.com.   AstraZeneca
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