ENGINEERING COMPLIANCE SPECIALIST

Job Summary

Responsible for the creation, implementation, administration and enforcement of all policies, procedures and compliance activities required to operate Plant Maintenance in accordance with the laws, policies and procedures applicable to the products manufactured at the Wilson facility. The incumbent will be responsible for PM coordination, CAPA’s, Change Controls, etc. as it relates to the site’s Plant Maintenance department.Responsibilities

• Administers the Work Order System and logs all relevant information into the database.
• Maintains the Preventive Maintenance module and update PM SOPs as required. Administers the PMs for each month and circulate the completed form for approval.
• Responsible for Change Control process for maintenance related systems: writes change control and logging out a number, circulates the form for pre- and post-approval, and finalizes the form.
• Maintains the miscellaneous department records (PMWO and MWO), daily log sheets and training records. Follows-up on outstanding paperwork completing, as required.
• Participates as directed in the planning and organization of resources for maintenance activities, including the compilation of completed records for shutdown documentation.
• Organizes and maintains the Maintenance drawings and equipment history files.
• Maintains the utility spreadsheets (electric, gas, water) by entering usage data from billing reports.
• Responsible for compiling and reporting weekly critical system release deliverables from facility maintenance department.
• Provide compliance metric reporting weekly and monthly for Quality Management reviews. Present information at plant level weekly meetings for PMs, calibrations, and AMS alarms.
• Prepares/reviews documentation, procedures, reports required for Annual Product Quality Review (APQR) from the facility maintenance department.
• Maintain site reporting for pest control status.
• Other duties and or projects as assigned.

Also responsible for

• Promoting continual improvement taking accountability for the effectiveness of the Environmental/Energy Management System.
• Responsible for ensuring Health, Safety and Environmental requirements are adhered to

REQUIREMENTS

• B.S in science or equivalent work experience.
• 5+ years in a maintenance role, preferable in the pharmaceutical industry or other similarly regulated industry.
• Strong organizational, interpersonal and communication skills.
• Knowledge of Excel, Power Point, SAP and good documentation practices.

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.