AstraZeneca Pharmaceuticals LP Facilities/Site Services Lead in West Chester, Ohio

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.

Provides leadership to the Facilities Engineering Department and coordinates activities across other Departments. Key contributor to site-wide strategy and executes cross-functional initiatives.

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.

  • 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.

  • Gather, organize, and communicate operational information to others.

  • Assist others in investigations and studies.

  • Use MAXIMO and/or CMMS (Computerized Maintenance Management System) to manage logistics.

  • Communicate priorities and progress to team on a continuing basis.

  • Ensure that employees have the tools needed to perform their jobs.

  • Facilitate communication between management and non-management.

  • 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.

  • Manage schedules, attendance, vacation time, and staffing coverage for the team.

  • Provide leadership, development, and mentoring for others.

  • Supervise day to day activities of others.

  • 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.

  • Initiate appropriate action when process deviations occur.

  • Monitor key performance indicators to meet strategic goals.

  • Monitor training of employees to ensure compliance.

  • Write, review, and revise SOPs (Standard Operating Procedures) for maintenance of equipment, systems, and/or facilities.

  • Attend inter-departmental meetings to discuss matters involving the coordination of multiple departments.

  • Coordinate with representatives from other departments.

  • Maintain job descriptions for accuracy for the team.

  • Review and approve OCMs, change controls, and document revisions.

  • Approve new and updated SOPs.

  • Attend team meetings to discuss progress, initiatives, and/or other matters.

  • Report process deviations when they occur.

  • Read and interpret diagrams, drawings, and other schematics.

  • Recommend and initiate activities to ensure area and equipment is maintained in a state of compliance.

  • Provide "off shift" support (for example: night shift support if you normally work day shift).

  • Assign work tasks and activities to others.

  • Provide input on the engineering of replacement parts.

  • Answer questions from others regarding parts, capital, sending parts out for repair, purchasing, and/or reliability.

  • Perform physical inspections of the site.

  • Manage team's priorities, goals, and resource allocation.

  • Provide 24/7 "on-call" support to others.

Other Duties:

  • Conduct troubleshooting activities.

  • Fill in for immediate supervisor when absent.

  • Lead process improvement activities and teams to meet strategic goals.

  • Investigate deviations.

  • Lead training on all document modifications prior to effective date.

  • Assist with coordinating activities of support groups.

  • Develop lean processes and procedures.

  • Identify temporary and permanent fixes to address issues.

  • Interact with regulatory agency personnel during audits and inspections.

  • Monitor records to ensure compliance with regulatory requirements.

  • Review and approve documentation needed for qualification of equipment and processes.

  • Lead and make final decisions regarding hiring (for example: conduct interviews, evaluate candidates).

  • Develop and track department budget.

  • Interact with other departments to implement corrective/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.

  • Collect, record, and report metrics.

  • Monitor equipment and/or systems for performance and problem indicators.

  • Read, understand, and comply with cGMP (Good Manufacturing Practices) and SOPs (Standard Operating Procedures), including general safety, lock outs, etc.

  • Ensure proper documentation practices during maintenance processes.

  • Maintain equipment and systems along with their certification records.

  • Assess and implement improvements in productivity, waste generation, quality and cost.

  • Conduct safety checks for work group, department, or site.

  • Coordinate events and meetings (for example: meeting space, food, attendees, audio visual).

  • Identify and develop criteria to monitor performance of a function or department.

  • Manage small- and mid-scale capital projects to ensure on-time and in-budget completion.

  • Maintain accurate and complete records (for example: laboratory notebooks, quality records, sample receipts).

  • Monitor air flow and balance.

  • Organize shut downs and/or maintenance windows.

  • Oversee departmental safety inspections.

  • Perform logbook reviews.

  • 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).

  • Track corporate quality KPIs (Key Performance Indicators).

Minimum Requirements:

  • 4-year degree in Engineering or related discipline and 10 years of experience leading others in a regulated or cGMP environment

Preferred Requirements:

  • Prior project management experience. Prior experience in maintenance, HVAC, electrical, control, BMS, EMS, and mechanical systems. Strong knowledge of CMMS.

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.