Senior Maintenance Planner
TekWissen ® · Frederick, MD · Yesterday
On-siteManagementTemporary
Responsibilities
- Plan and schedule preventive maintenance (PM) and corrective maintenance work orders using CMMS systems.
- Cook up maintenance activities with Facilities, Production, Quality, EH&S, Engineering, and external contractors to keep operations running smoothly.
- Maintain PM compliance targets and manage work order backlogs through reporting and scheduling activities.
- Build and maintain PM job plans including labor estimates, tools, parts, procedures, and GMP documentation requirements.
- Administer and maintain CMMS asset data, equipment history, PM frequencies, spare parts lists, and asset hierarchies.
- Generate KPI reports, PM compliance metrics, backlog reports, reliability reports, and maintenance dashboards.
- Author and revise SOPs, Methods of Procedure (MOPs), work instructions, PM task sheets, Change Controls, CAPAs, and audit responses.
- Review completed work orders and maintenance records to ensure compliance with cGMP and Good Documentation Practices (GDP).
- Manage service agreements, contractor schedules, purchase requisitions, and vendor performance.
- Cook up facility shutdowns, maintenance outages, and equipment tie-ins while keeping production impact low.
- Track engineering service requests and support completion activities.
- Maintain training records, compliance matrices, and department training schedules.
- Support facility security access and contractor onboarding processes.
- Develop and present maintenance performance metrics and continuous improvement initiatives.
- Participate in audits, inspections, safety programs, and process improvement activities.
Requirements
- Associate degree in Engineering, Facilities Management, Business, Technical Studies, or a related field required.
- Minimum 6-8 years of facilities planning, scheduling, maintenance coordination, or maintenance administration experience.
- Minimum 5 years of experience in a GMP-regulated biotechnology, pharmaceutical, or life sciences manufacturing environment.
- Experience as a CMMS power user or administrator (Blue Mountain RAM, Maximo, SAP PM, eMaint, or similar).
- Proven experience authoring and managing GMP documentation including: Change Controls, CAPAs, Audit Responses, SOPs, MOPs, PM Task Sheets.
- Experience managing contractors, vendors, and service agreements.
- Advanced Microsoft Excel skills including Pivot Tables, VLOOKUP/XLOOKUP, formulas, and conditional formatting.
- Proficiency with Microsoft Word, PowerPoint, and Visio.
- Strong knowledge of FDA cGMP regulations, ISO standards, and EH&S requirements.
- Excellent communication, organizational, and project coordination skills.
- Valid driver's license required.
Preferred Qualifications
- Bachelor's degree in Engineering, Facilities Management, Business Administration, Supply Chain, or a related field.
- Advanced Blue Mountain RAM CMMS administration experience.
- OSHA 10-Hour General Industry Certification.
- Experience with Power BI and maintenance KPI dashboards.
- Knowledge of SMRP maintenance planning and scheduling best practices.
- Experience with capital projects, outage planning, and shutdown management.
- Familiarity with: FDA 21 CFR Parts 11, 210, and 211, ICH Q7, Q9, and Q10, ISPE GAMP 5, Strong reliability engineering and maintenance KPI reporting experience.