Reliability Engineer; MN
Listed on 2025-12-28
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Engineering
Quality Engineering, Manufacturing Engineer
Description
Excel Engineering is seeking a team-oriented, highly motivated hands-on Reliability Engineer to elevate equipment performance and asset integrity across a cGMP pharmaceutical production environment. You’ll be a key player in the reliability program assessing criticality analysis, preventive & predictive strategies, root-cause investigations, and continuous improvement that safeguards product quality, throughput, and compliance.
Since 1990, Excel Engineering has differentiated its services from that of its competition by providing engineering solutions to achieve our clients’ business objectives.
Primary Responsibilities- Asset Strategy & Planning:
Build and maintain asset hierarchies; perform equipment criticality analysis, FMEA, and develop risk-based PM/PdM plans. - Predictive Maintenance (PdM):
Deploy and interpret condition monitoring (vibration, infrared/thermography, ultrasonic, oil analysis) to anticipate failures and optimize maintenance intervals. - CMMS Excellence:
Configure and improve workflows in CMMS (e.g., SAP PM/Maximo) for work orders, BOMs, spare parts, and maintenance KPIs; drive data accuracy and 21 CFR Part 11-aligned record integrity. - RCA & CAPA:
Facilitate structured Root Cause Analysis (5-Whys, Ishikawa) and author CAPA plans that are compliant, effective, and auditable; track effectiveness checks. - Utilities & Process Equipment:
Own reliability strategies for sterile utilities and process systems (e.g., WFI, clean steam, HVAC/HEPA, compressed air, autoclaves, reactors, etc). - Turnarounds & Change Control:
Plan maintenance windows/turnarounds; collaborate via formal change control for reliability-driven modifications; support validation/qualification impacts (IQ/OQ/PQ readiness). - Parts & Cost Optimization:
Set stocking strategies for critical spares; evaluate lifecycle costs, MTBF/MTTR, and repair/replace decisions; manage vendor performance. - KPIs & Reporting:
Define and publish metrics (OEE, PM compliance, maintenance backlog, failure rates, cost per asset); run daily/weekly tier meetings and lead continuous improvement sprints. - Cross-Functional Collaboration:
Partner with Operations, Quality, Validation, EHS, and Engineering; train technicians on reliability standards and PdM tools; support audit responses (FDA/EMA).
Education
· Bachelors or Masters’ Degree in Chemical, Mechanical or Electrical Engineering from an ABET Accredited Institution.
· Cumulative GPA of 3.0 or higher on a 4.0 Scale.
Qualifications
- Experience:
5–10+ years in reliability/maintenance within industrial manufacturing sector;
Preferred experience in cGMP environment. - Technical:
Proficiency in CMMS (SAP PM, Maximo or similar), PdM technologies, failure analysis methodologies (FMEA, Weibull), and maintenance planning/scheduling. - Soft Skills:
Strong facilitation and communication skills; ability to influence cross-functional teams; crisp technical writing for investigations and protocols. - Preferred: CMRP/CRE certifications, pharmaceutical utilities experience (WFI, clean steam), aseptic/sterile manufacturing exposure, TPM/Lean background.
Additional Skills Applicable to the Role
- Excellent interpersonal skills, as well as verbal and written communications.
- Ability to work collaboratively with individuals at all levels in the organization in a team environment.
- Knowledge of relevant technical software.
- Knowledge of MS Office software products:
Word/Excel/Outlook.
Excel Engineering is focused on cultivating a high performing culture where a service oriented approach, continuous improvement and goal orientation are valued. If you enjoy working in a fast paced, challenging and rewarding environment, Excel Engineering is for you!
Excel Engineering is an Equal Opportunity Employer.?Applicants will receive consideration for employment regardless of their race, color, religion, national origin, sex, sexual orientation, disability, age, veteran status, marital status, or status with regard to public assistance. In our commitment to diversity, equity, and inclusion, we strongly encourage applicants from populations that are underrepresented in the engineering field to apply. For applicants who need an accommodation to apply, please contact human resources at
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