What are the responsibilities and job description for the Preventative Maintenance Engineer position at Fustis LLC?
Title: Preventative Maintenance Engineer
Location: Waunakee, WI - 100% Onsite
Rate: 75hr C2C All
Duration: 6 months plus
Critical Must-Haves (Top 4)
Technical writing capability to produce FDA-defensible, equipment-specific PM justifications. This isn//'t checkbox documentation - each piece of equipment needs written rationale grounded in technical facts that explains why specific PM tasks are required and why the intervals are appropriate. The justification must connect equipment function failure modes CPP/CQA protection PM task interval basis (OEM data, wear history, validation requirements, etc.). Candidates who can only describe /"reviewing/" or /"approving/" documentation - rather than authoring technically rigorous justifications from scratch - will not succeed in this role.
Mechanical/process engineering understanding of complex pharmaceutical processing equipment. The candidate must be able to look at a horizontal decanter, basket centrifuge, freeze dryer, or conical vacuum dryer and understand how it works mechanically - how the components interact, what each subsystem does, and how the equipment protects product quality. Without this foundational equipment knowledge, they cannot credibly identify failure scenarios that could affect product, evaluate whether existing PMs adequately address those failure modes, or write technically sound justifications. This requires either formal mechanical engineering background or substantial hands-on experience maintaining and troubleshooting this class of equipment.
Direct experience with equipment criticality/impact assessments (SLIA/CLIA or equivalent). The ability to interpret System Level and Component Level Impact Assessments and use them to classify equipment as GMP-critical is foundational to your Q-category determination. Candidates without this experience will struggle to distinguish what makes a component quality-critical versus merely operational.
Familiarity with FMEA or structured risk assessment methodology. Your framework requires scoring Severity, Occurrence, and Detection on defined scales and calculating RPN. Candidates who haven//'t worked with FMEA will need significant ramp-up time to apply your scales consistently and defensibly.
Complete Role Requirements (12 Points)
Mechanical/Process Equipment Expertise
Demonstrate working knowledge of complex pharmaceutical processing equipment - horizontal decanters, basket centrifuges, freeze dryers, conical vacuum dryers, and similar equipment - understanding how these machines function mechanically and how their components interact
Identify how specific equipment components and subsystems (seals, bearings, agitator drives, vacuum systems, heating/cooling systems, product-contact surfaces) protect product quality during processing
Analyze credible failure scenarios for each component - what happens when a seal degrades, a bearing fails, vacuum integrity is lost, temperature control drifts - and articulate how those failures could impact CPPs, CQAs, or introduce extraneous material
Technical Writing & FDA-Defensible Documentation
Author detailed, technically rigorous justifications for each PM task that explain the /"why/" - connecting equipment function to failure modes to CPP/CQA protection - written to withstand FDA inspector scrutiny
Document interval justifications grounded in technical facts: OEM recommendations, equipment wear history, validation requirements, failure data, or engineering analysis - not just /"we//'ve always done it this way/"
Produce evaluation forms and assessment documentation that are clear, traceable to source documents, and demonstrate a systematic, risk-based approach to PM program management
Process Validation & CPP Understanding
Review and interpret Process Validation documentation to identify Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs) controlled by specific equipment
Trace the connection from CPPs back to the equipment components and functions that control them - understanding mechanically how equipment failures could impact product quality (contamination, process excursions, loss of control)
Equipment Criticality Assessment
Interpret SLIA (System Level Impact Assessment) and CLIA (Component Level Impact Assessment) documents to identify which equipment and components are classified as GMP-critical
Evaluate high-wear areas and supporting systems not captured in formal impact assessments - using mechanical knowledge to determine what could shed particles, leak, seize, or degrade in ways that affect product
Risk-Based Categorization
Apply FMEA methodology to score PMs using defined Severity, Occurrence, and Detection scales, calculating Risk Priority Numbers (RPN) - with written justification for each score grounded in mechanical understanding of failure likelihood and consequences
Correctly categorize PMs into Q (Quality/GMP), S (Safety), or B (Best Practice) categories using hierarchical decision logic, documenting the categorization rationale for each PM
Location: Waunakee, WI - 100% Onsite
Rate: 75hr C2C All
Duration: 6 months plus
- Role: Our client is looking to bring on a Preventative Maintenance Engineer for a 6 month plus project. This Engineer will be working on the client’s preventative maintenance equipment to make it more robust. They will be doing risk based approaches and making sure that the Equipment is GMP compliant and the mechanical systems are working well. If issues come up, they will categorize them as priority 1, priority 2, etc. They goal is to make the systems work better. They will also be evaluating best practices for the preventative maintenance equipment. Client is looking for 5-7 years of Preventative maintenance experience and experience working with more complex equipment in the pharmaceutical/biotech industry.
- Most Important Skills Needed: Preventative Maintenance Engineering, Mechanical Equipment, Risk based approaches, pharmaceutical/biotech
Critical Must-Haves (Top 4)
Technical writing capability to produce FDA-defensible, equipment-specific PM justifications. This isn//'t checkbox documentation - each piece of equipment needs written rationale grounded in technical facts that explains why specific PM tasks are required and why the intervals are appropriate. The justification must connect equipment function failure modes CPP/CQA protection PM task interval basis (OEM data, wear history, validation requirements, etc.). Candidates who can only describe /"reviewing/" or /"approving/" documentation - rather than authoring technically rigorous justifications from scratch - will not succeed in this role.
Mechanical/process engineering understanding of complex pharmaceutical processing equipment. The candidate must be able to look at a horizontal decanter, basket centrifuge, freeze dryer, or conical vacuum dryer and understand how it works mechanically - how the components interact, what each subsystem does, and how the equipment protects product quality. Without this foundational equipment knowledge, they cannot credibly identify failure scenarios that could affect product, evaluate whether existing PMs adequately address those failure modes, or write technically sound justifications. This requires either formal mechanical engineering background or substantial hands-on experience maintaining and troubleshooting this class of equipment.
Direct experience with equipment criticality/impact assessments (SLIA/CLIA or equivalent). The ability to interpret System Level and Component Level Impact Assessments and use them to classify equipment as GMP-critical is foundational to your Q-category determination. Candidates without this experience will struggle to distinguish what makes a component quality-critical versus merely operational.
Familiarity with FMEA or structured risk assessment methodology. Your framework requires scoring Severity, Occurrence, and Detection on defined scales and calculating RPN. Candidates who haven//'t worked with FMEA will need significant ramp-up time to apply your scales consistently and defensibly.
Complete Role Requirements (12 Points)
Mechanical/Process Equipment Expertise
Demonstrate working knowledge of complex pharmaceutical processing equipment - horizontal decanters, basket centrifuges, freeze dryers, conical vacuum dryers, and similar equipment - understanding how these machines function mechanically and how their components interact
Identify how specific equipment components and subsystems (seals, bearings, agitator drives, vacuum systems, heating/cooling systems, product-contact surfaces) protect product quality during processing
Analyze credible failure scenarios for each component - what happens when a seal degrades, a bearing fails, vacuum integrity is lost, temperature control drifts - and articulate how those failures could impact CPPs, CQAs, or introduce extraneous material
Technical Writing & FDA-Defensible Documentation
Author detailed, technically rigorous justifications for each PM task that explain the /"why/" - connecting equipment function to failure modes to CPP/CQA protection - written to withstand FDA inspector scrutiny
Document interval justifications grounded in technical facts: OEM recommendations, equipment wear history, validation requirements, failure data, or engineering analysis - not just /"we//'ve always done it this way/"
Produce evaluation forms and assessment documentation that are clear, traceable to source documents, and demonstrate a systematic, risk-based approach to PM program management
Process Validation & CPP Understanding
Review and interpret Process Validation documentation to identify Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs) controlled by specific equipment
Trace the connection from CPPs back to the equipment components and functions that control them - understanding mechanically how equipment failures could impact product quality (contamination, process excursions, loss of control)
Equipment Criticality Assessment
Interpret SLIA (System Level Impact Assessment) and CLIA (Component Level Impact Assessment) documents to identify which equipment and components are classified as GMP-critical
Evaluate high-wear areas and supporting systems not captured in formal impact assessments - using mechanical knowledge to determine what could shed particles, leak, seize, or degrade in ways that affect product
Risk-Based Categorization
Apply FMEA methodology to score PMs using defined Severity, Occurrence, and Detection scales, calculating Risk Priority Numbers (RPN) - with written justification for each score grounded in mechanical understanding of failure likelihood and consequences
Correctly categorize PMs into Q (Quality/GMP), S (Safety), or B (Best Practice) categories using hierarchical decision logic, documenting the categorization rationale for each PM
Salary : $70 - $75