Maintenance Planning and Engineering Compliance Coordinator

SPL Biopharma
  • Waunakee, WI
    14 days ago

    Job Description

    JOB SUMMARY

    Join our team at Scientific Protein Laboratories (SPL), a world leader in biosourced pharmaceuticals, located just outside of Madison, Wisconsin in Waunakee! SPL is an innovative biopharmaceutical leader with unique products and services supporting the pharmaceutical industry globally. For over 40 years, SPL specializes in the development and cGMP compliant manufacturing of Active Pharmaceutical Ingredients (APIs).SPL has an exciting opportunity to join the team as a Maintenance Planning & Engineering Compliance Coordinator.

    This position is responsible for planning, scheduling, and coordinating maintenance activities while administering engineering compliance processes for the Engineering & Maintenance department. The role manages maintenance work flow, CMMS planning, backlog prioritization, change controls, ECNs, CAPAs, deviations, KPI reporting, contractor coordination, and parts readiness to maximize workforce productivity, regulatory compliance, and equipment reliability. The position reports to the Senior Manager of Asset Reliability & Engineering Compliance and partners closely with Maintenance Supervisors, Manufacturing, Quality, Engineering, and Procurement.

    Responsibilities include:

    • Maintain the master schedule for corrective, preventive, predictive, shutdown, and project work orders.
    • Develop weekly and monthly maintenance schedules with maintenance supervisors and manufacturing.
    • Maintain CMMS including work order creation, planning, labor reporting, PM generation, and equipment record.
    • Maintain schedule compliance along with work order backlog age and trend.
    • Manage maintenance backlog, prioritize work, stage jobs, and ensure materials and permits are available before execution.
    • Coordinate with storeroom and procurement to ensure parts, kits, and contractor resources are available for planned work.
    • Administer department change controls and ECNs including routing, tracking with closure rate, follow-up, and documentation.
    • Coordinate deviations and CAPAs by engaging SMEs, tracking timelines, and ensuring documentation is complete with on-time closure.
    • Develop PM job plans, bills of material, spare parts lists, and documentation for new and existing equipment.
    • Participate in maintenance, production, engineering, and QA planning meetings to optimize schedules.
    • Coordinate contractor access, facility testing, and outside service activities.
    • Maintains the mechanic training matrix, identifying potential learning and certification opportunities while updating the skill set when completing trainings.
    • Support continuous improvement initiatives.
    • Assist with department administrative activities as assigned.
    • Perform other duties as assigned.

    | || |

    Job Requirements and Qualifications:

    • Education: High School Diploma or G.E.D. required
    • Bachelor’s Degree or above in applicable field preferred
    • Experience: 1 plus years of experience required, 2 plus years of experience preferred

    WHY JOIN SPL?

    Our employees are our success! We recruit motivated people, recognize their contributions, and support their development to reach their full potential.

    Perks include: competitive compensation; excellent benefits package - including Medical, Dental and Vision on Day 1; Life and AD&D Insurance, and Short and Long-term Disability; Health and Flexible Saving Account options; Employee Assistance Program, generous vacation; paid Holidays; 401k; advancement opportunities; team-oriented environment; community involvement; company events and more!

    SPL is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law.

    You should be proficient in:

    • CMMS
    • Maintenance
    • maintenance technician
    • metrology
    • QMS
    • GMP

    Machines & technologies you'll use:

    • maintenance
    • maintenance planning

    Numbers & Facts

    LocationWaunakee, WI

    Skills

    • Active Pharmaceutical Ingredient (API)unmatched
    • Application Programming Interface (API)unmatched
    • Backlog Prioritizationunmatched
    • Bill of Materials (BOM)unmatched
    • Biotech and Pharmaceuticalunmatched
    • Calendar Managementunmatched
    • Change Controlunmatched
    • Computerized Maintenance Management System (CMMS)unmatched
    • Continuous Improvementunmatched
    • Current Good Manufacturing Practice (cGMP)unmatched
    • Documentationunmatched
    • Drug Manufacturingunmatched
    • GMP (Good Manufacturing Practices)unmatched
    • Laboratoryunmatched
    • Maintain Complianceunmatched
    • Maintenance Servicesunmatched
    • Manufacturing Managementunmatched
    • Materials Planningunmatched
    • Metrologyunmatched
    • Performance Metricsunmatched
    • Plan Meetingsunmatched
    • Product Supportunmatched
    • Productivity Managementunmatched
    • Purchasing/Procurementunmatched
    • Quality Assuranceunmatched
    • Quality Engineeringunmatched
    • Regulatory Complianceunmatched
    • Reliability Engineeringunmatched
    • Time Managementunmatched

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