General Duties
- Read SOPs (Standard Operating Procedures) and excerpts from technical documentation.
- Author SOPs and Work Instructions in the department27s area of responsibility.
- Train others on systems, software, equipment, machines, procedures, and/or processes.
- Facilitate team meetings to discuss progress, initiatives, and/or other matters.
- Wear gowning, sterile garments, and PPE (Personal Protective Equipment) as required by specific activities.
- Provide leadership, development, and mentoring for others.
- Evaluate new software and/or tools.
- Lead and support change control activities.
- Serve as SME (subject matter expert) for CMMS.
- Lead coordination of shutdown activities for the plant across all PETs and BETs.
Asset Reliability & Performance
- Develop and execute equipment reliability strategies for packaging and inspection assets.
- Monitor and analyze equipment performance (OEE, MTBF, MTTR) to identify improvement opportunities.
- Lead reliability/spare parts meetings.
- Lead reliability/spare parts meetings.
Maintenance Strategy & Optimization
- Execute and manage master data requests to support BOM accuracy, maintenance plans, and asset reliability.
- Develop and optimize preventive and predictive maintenance plans.
- Perform PM effectiveness reviews and adjust frequencies based on failure data.
- Root Cause Analysis (RCA) & Continuous Improvement
- Lead and facilitate root cause investigations for major equipment failures.
- Apply structured RCA methodologies (5-Why, Fishbone, Fault Tree, etc.).
- Track corrective and preventive actions to closure.
- Identify recurring failure modes and implement permanent fixes.
- Identify recurring failure modes and implement permanent fixes.
Spare Parts & Asset Lifecycle Management
- Define and maintain critical spare parts strategies (min/max, stocking levels).
- Create and maintain spare parts in SAP, including material master data and related attributes.
- Support BOM accuracy and completeness for production equipment.
- Evaluate spare part consumption trends and lead time risks.
- Support Part Equivalency Forms (PEFs) and technical evaluations.
- Data Analytics & Reliability Reporting
- Develop and maintain reliability dashboards and KPIs.
- Analyze work order history to identify trends and bad actors.
- Analyze work order history to identify trends and bad actors.
Capital Projects & Equipment Readiness
- Provide reliability input during equipment design, FAT/SAT, and commissioning.
- Ensure maintainability and spare parts strategies are defined for new assets.
- Support equipment lifecycle planning.
- Cross-Functional Collaboration
- Partner with Maintenance, Operations, Engineering, and Quality.
- Work with OEMs and vendors to resolve chronic equipment issues.
- Work with OEMs and vendors to resolve chronic equipment issues.
Compliance & Documentation
- Ensure maintenance and reliability practices meet GMP requirements.
- Support audit readiness for equipment and maintenance programs.
- Support SOP and job plan development and updates.
- Ensure data accuracy within SAP and reliability systems.
- Track preventive maintenance compliance for the site.
Minimum Requirements
Significant experience supporting reliability in a manufacturing environment.
Solid experience in Production, Maintenance, leading projects, and/or Engineering Improvements.
Strong mechanical/technical aptitude
Preferred Background
Bachelor27s degree in engineering, or related science
In-depth knowledge of CMMS.
Significant experience supporting reliability in a regulated or cGMP environment.
CRE (Certified Reliability Engineer), CRL (Certified Reliability Leader) and/or CMRP (Certified Maintenance and Reliability Practitioner) certificationPosition Summary & Responsibilities
