Maintenance Planning and Engineering Compliance Coordinator
Ora
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.
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
You Should Be Proficient In
- CMMS
- Maintenance
- maintenance technician
- metrology
- QMS
- GMP
Requirements
- High School Diploma or G.E.D. required
- Bachelor's Degree or above in applicable field preferred
- 1 plus years of experience required
- 2 plus years of experience preferred
- Proficient in CMMS
- Proficient in maintenance
- Proficient in maintenance technician
- Proficient in metrology
- Proficient in QMS
- Proficient in GMP
Benefits
- Medical Insurance
- Dental Insurance
- Vision Insurance
- Life Insurance
- AD&D Insurance
- Short-Term Disability Insurance
- Long-Term Disability Insurance
- Health Savings Account
- Flexible Spending Account
- Employee Assistance Program
- Paid Vacation
- Paid Holidays
- 401(k)
- Advancement Opportunities
- Team-Oriented Environment
- Community Involvement
- Company Events
Company overview
Ora is the world's leading full-service ophthalmic drug and device development firm, operating as a specialized contract research organization (CRO) focused exclusively on ophthalmology. Founded in 1974 and headquartered in Andover, Massachusetts, the company has over 45 years of experience in advancing eye care innovations globally. Ora provides comprehensive research and development services spanning preclinical studies, clinical trials, regulatory strategy, and product development for both pharmaceutical and medical device companies. With operations across the United States, United Kingdom, Australia, and Asia, the company has helped clients achieve more than 85 product approvals to date. Ora's expertise covers a wide range of ophthalmic conditions including allergy, dry eye, retina diseases, glaucoma, and anti-infective therapies. The company employs over 500 ophthalmology specialists who utilize proprietary clinical models, integrated data solutions, and global regulatory strategies to accelerate product development from concept to market. Ora serves a diverse client base ranging from startups to global pharmaceutical and device companies, positioning itself as the trusted partner for ophthalmic innovation worldwide.