Principal Reliability Engineer - Manufacturing & Process

ProQuality Network

Northern (KY)

Hybrid

USD 120,000 - 180,000

Full time

3 days ago

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Job summary

ProQuality Network is seeking a highly experienced Principal Engineer (Reliability) to coordinate complex engineering projects across process engineering, unit operations, and equipment engineering. The role supports characterization, optimization, scale-up, and manufacturing operations in a highly regulated environment.

Responsibilities include leading multi-discipline teams, applying advanced reliability methodologies, and driving asset performance strategies.

Qualifications

Experience applying reliability engineering methodologies such as FMEA, RCM, RCA, Weibull Analysis, and predictive analytics to enhance equipment and system performance.
Experience managing and interpreting equipment reliability metrics (MTBF, MTTR, OEE) to identify and prioritize improvement opportunities.
Professional certifications preferred (e.g., CMRP, CRE, PE).
Demonstrated success implementing reliability engineering programs and asset performance strategies.
Experience with CMMS and predictive maintenance systems (e.g., Maximo, SAP, XFRACAS, ReliaSoft).
Strong analytical and problem-solving skills with the ability to translate complex data into actionable insights.
Working knowledge of pharmaceutical or biotech processes.
Familiarity with validation processes and documentation requirements in a highly regulated environment.
Ability to operate specialized laboratory equipment and computerized systems.
Ability to interpret and apply GLPs and GMPs.
Ability to apply engineering science within production environments.
Ability to develop solutions to technical problems of limited or moderate scope.
Demonstrated proficiency in:
Problem-solving and applied engineering
Basic technical report writing
Verbal communication
Comprehensive understanding of validation protocol execution requirements.

Responsibilities

Establish engineering policies for major operational segments of the company.
Interpret, execute, and recommend modifications to company-wide engineering policies and procedures.
Develop project and organizational budgets that encompass all engineering disciplines for large and complex initiatives.
Apply advanced engineering principles to develop new methods or expand existing methodologies.
Conduct in-depth technical investigations, define project scope, identify research areas, and develop innovative concepts.
Plan and execute engineering research or investigations of significant scope and complexity.
Organize, lead, and coordinate the work of engineering teams, including engineers and technicians.
Collaborate with research, manufacturing, process development, utilities, facilities, quality assurance, and validation groups to develop requirements and recommendations for major system, facility, or process modifications.
Serve as a corporate engineering resource with specialization in multiple engineering disciplines.
Design, execute, implement, and oversee engineering or process projects that significantly contribute to high-priority organizational goals.
Perform additional duties as assigned.