Senior Engineer, Facilities Engineering - West Chester, OH | Biospace
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Senior Engineer, Facilities Engineering

AstraZeneca Pharmaceuticals LP

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Location:
West Chester, OH
Posted Date:
4/28/2017
Position Type:
Full time
Job Code:
R-004378
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

                             
                                       Location:West Chester, Ohio, United States
Job reference: R-004378

Posted date: Mar. 17, 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, Facilities Engineering in West Chester, Ohio, 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.

As the Senior Engineer, Facilities Engineering you will act in a leadership role in providing engineering support and technical expertise for GMP and non-GMP, utility systems, and related equipment.  

 

Essential Job Functions:    
   •   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.    
   •   Perform visual inspections.    
   •   Conduct troubleshooting activities.    
   •   Responsible for HVAC and Refrigeration systems.    
   •   Manage clean rooms re-certification process.    
   •   Knowledge of bulk storage and distribution of solvents, and recovery of solvent vapors.    
   •   Gather, organize, and communicate operational information to others.    
   •   Lead and coordinate investigations and studies with little supervision.    
   •   Use SAP and/or CMMS (Computerized Maintenance Management System) to manage logistics.    
   •   Provide leadership, development, and mentoring for others.    
   •   Identify temporary and permanent fixes to address issues.    
   •   Initiate appropriate action when process deviations occur.    
   •   Monitor records to ensure compliance with regulatory requirements.    
   •   Coordinate with representatives from other departments.    
   •   Attend team meetings to discuss progress, initiatives, and/or other matters.    
   •   Monitor equipment and/or systems for performance and problem indicators.    
   •   Perform data entry.    
   •   Read, understand, and comply with cGMP (Good Manufacturing Practices) and SOPs (Standard Operating Procedures), including general safety, lock outs, etc.    
   •   Report process deviations when they occur.    
   •   Wear gowning, sterile garments, and PPE (Personal Protective Equipment) as required by specific activities.    
   •   Perform preventive (scheduled) and corrective/emergency (unscheduled) maintenance of equipment, systems, and/or facilities without supervision.    
   •   Ensure proper documentation practices during maintenance processes.    
   •   Maintain equipment and systems along with their certification records.    
   •   Read and interpret diagrams, drawings, and other schematics.    
   •   Recommend and initiate activities to ensure area and equipment is maintained in a state of compliance.    
   •   Monitor air flow and balance.    
   •   Perform infrared, vibration, pressure, superheat, and subcooling readings.    
   •   Perform routine sampling activities.    
   •   Performing high purity water testing.    
   Other Duties:    
   •   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.    
   •   Lead process improvement activities and teams to meet strategic goals.    
   •   Participate in spill control, handling of hazardous materials, and first aid.    
   •   Communicate priorities and progress to team on a continuing basis.    
   •   Facilitate team meetings to discuss progress, initiatives, and/or other matters.    
   •   Guide others on SOPs (Standard Operating Procedures), control documents, and/or other work instructions.    
   •   Supervise day to day activities of others.    
   •   Coordinate activities of support groups.    
   •   Analyze trends in data in order to provide accurate descriptions, identify root causes, and/or identify solutions or improvements.    
   •   Close out deviations, CAPAs, and/or pAFCAs as needed.    
   •   Interact with regulatory agency personnel during audits and inspections.    
   •   Monitor key performance indicators to meet strategic goals.    
   •   Perform regular audits of SOPs (Standard Operating Procedures) and/or work instructions.    
   •   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.    
   •   Assist with recruiting/interviewing/evaluating prospective employees.    
   •   Attend inter-departmental meetings to discuss matters involving the coordination of multiple departments.    
   •   Facilitate inter-departmental meetings to discuss matters involving the coordination of multiple departments.    
   •   Interact with other departments to implement corrective/preventative actions.    
   •   Participate in cross-functional teams to meet strategic goals.    
   •   Participate in new equipment design specification.    
   •   Read technical publications and manuals, and write associated procedures.    
   •   Write, review and approve OCMs, change controls, and document revisions.    
   •   Collect, record, and report metrics.    
   •   Execute validation protocols for processes, equipment, packaging, and/or cleaning.    
   •   Generate validation protocols for processes, equipment, and/or packaging.    
   •   Assess and implement improvements in productivity, waste generation, quality and cost.    
   •   Provide input on the engineering of replacement parts.    
   •   Assist process engineering and managers with improvement projects.    
   •   Lead committees or groups of employees tasked with accomplishing some objective(s).    
   •   Conduct presentations (other than training) for different audiences.    
   •   Consult cross-functionally as an SME (Subject Matter Expert) on systems and/or processes within a functional area.    
   •   Coordinate qualification activities.    
   •   Create specifications for equipment.    
   •   Create, generate, type, proof, and distribute correspondences.    
   •   Design and deploy new machines.    
   •   Answer questions from others regarding parts, capital, sending parts out for repair, purchasing, and/or reliability.    
   •   Lead change control activities.    
   •   Lead teams in root cause analysis sessions.    
   •   Manage small- and mid-scale capital projects to ensure on-time and in-budget completion.    
   •   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.    
   •   Manage supplier activities during design, fabrication, installation, commissioning, and qualification.    
   •   Organize shut downs and/or maintenance windows.    
   •   Oversee validation activities.    
   •   Perform gap analyses and assessments for integration.    
   •   Support LDAR (Leak Detection and Repair) monitoring program.    
   •   Provide 24/7 "on-call" support to others.    
   •   Provide, verify, measure, and revise drawings.    
   •   Recommend compliance resolutions to management.    
   •   Review and approve requirements, specifications, drawings, coding procedures, and guidelines.    
   •   Serve as SME (subject matter expert) and/or primary point of contact for various safety initiatives (for example: quarterly departmental safety inspections, fire and light safety, industry safe program, process safety management program).    
   •   Wear harnesses to climb into tanks.    
   Essential Requirements:    
   •   4-year degree in Engineering and 7 years of experience supporting facilities engineering within a regulated or cGMP environment.    
   Preferred Requirements:    
   •   Master’s degree in Engineering. Experience utilizing CMMS.  

 

   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.    
 

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