Maintenance Engineer

Job Title: Preventive Maintenance Engineer

We are seeking an experienced Preventative Maintenance Engineer to support a 6+ month engagement focused on strengthening and optimizing preventative maintenance (PM) programs for complex pharmaceutical processing equipment.

This role will apply risk-based methodologies to ensure GMP compliance, enhance equipment reliability, and improve mechanical system performance. The engineer will evaluate existing PM strategies, identify gaps, categorize risks by priority (Priority 1, 2, etc.), and implement technically defensible improvements aligned with regulatory expectations.

• Develop and enhance robust, risk-based preventative maintenance strategies for GMP manufacturing equipment.
• Author FDA-defensible, equipment-specific PM justifications from scratch.
• Evaluate and optimize PM intervals using:
• OEM recommendations
• Historical wear and failure data
• Validation requirements
• Equipment performance trends
• Perform equipment criticality and impact assessments (SLIA/CLIA or equivalent).
• Conduct structured risk assessments using FMEA methodology.
• Score Severity, Occurrence, and Detection; calculate and justify RPN values.
• Categorize and prioritize equipment issues (Priority 1, 2, etc.) based on risk to product quality and compliance.
• Ensure mechanical systems and processing equipment remain GMP compliant.
• Assess best practices and recommend improvements to preventative maintenance programs.
• Collaborate cross-functionally with Quality, Validation, Engineering, and Manufacturing teams.

1. Technical Writing – FDA-Defensible PM Justifications

• Demonstrated ability to author technically rigorous PM justifications.
• Must clearly connect:
• Equipment function
• Failure modes
• CPP/CQA impact
• Preventative maintenance task
• Experience writing from scratch — not just reviewing or approving documentation.

Strong understanding of complex pharmaceutical processing equipment such as:

• Mechanical interactions between subsystems
• Failure mechanisms
• Impact of mechanical degradation on GMP compliance

Formal mechanical engineering background or extensive hands‑on troubleshooting experience required.

3. Equipment Criticality & Impact Assessment Experience

• Direct experience with SLIA, CLIA, or equivalent frameworks.
• Ability to distinguish GMP‑critical components from operational components.
• Strong understanding of quality impact classification and Q‑category determination.

4. FMEA / Structured Risk Assessment

• Hands‑on experience conducting FMEA.
• Ability to:
• Define Severity, Occurrence, Detection scales
• Calculate RPN
• Apply risk scoring consistently and defensibly
• Experience applying risk‑based approaches in GMP environments.

• 5–7+ years of Preventative Maintenance Engineering experience
• Experience in pharmaceutical or biotech GMP environments
• Strong mechanical equipment background
• Experience with complex processing equipment
• Risk‑based maintenance methodology expertise
• Excellent technical documentation and analytical skills