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. Youll 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).
Requirements
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: 510 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.
We offer a competitive salary and benefits package.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 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
Salary Description
$100000 - $130000 a year
Required Experience:
IC
Full-timeDescriptionExcel 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. Youll be a key player in the reliability program assessing criticality analysis pr...
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. Youll 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).
Requirements
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: 510 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.
We offer a competitive salary and benefits package.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 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
Salary Description
$100000 - $130000 a year
Required Experience:
IC
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