Maintenance Engineer - Pharmaceutical Manufacturing (OSD)

Maintenance Engineer - Pharmaceutical Manufacturing (OSD)

Location: Virginia, USA Chantilly

Job Type: Full-Time

Industry: Pharmaceutical Manufacturing

Job Summary

We are seeking a skilled and proactive Maintenance Engineer with experience in oral solid dosage (OSD) pharmaceutical manufacturing. The ideal candidate will be responsible for ensuring the reliable operation, maintenance, and continuous improvement of manufacturing equipment and facility systems to support safe, compliant, and efficient production.

This role requires strong troubleshooting abilities across mechanical, electrical, pneumatic, and automation systems, along with experience supporting equipment qualification and validation activities in a regulated pharmaceutical environment.

Key Responsibilities

Perform preventive, predictive, and corrective maintenance on pharmaceutical manufacturing equipment including:

Blenders, granulators, mills

Fluid bed coaters

Tablet presses and capsule fillers

Coating machines

Packaging lines (bottle, blister, cartoners)

Troubleshoot mechanical, electrical, pneumatic, and automation issues to minimize equipment downtime.

Support equipment installation, commissioning, and qualification activities (IQ/OQ/PQ).

Maintain accurate maintenance records, work orders, and equipment logs in the CMMS system.

Ensure all maintenance activities comply with cGMP, FDA regulations, and safety standards.

Collaborate with Production, Quality, and Engineering teams to resolve equipment-related issues.

Participate in Root Cause Analysis (RCA) and implement Corrective and Preventive Actions (CAPA).

Identify opportunities for equipment upgrades, reliability improvements, and process optimization.

Support internal and regulatory audits by providing documentation and technical support.

Manage and maintain spare parts inventory to ensure operational readiness.

Required Qualifications

Bachelor's degree in mechanical, Electrical, Industrial Engineering, or related field (or equivalent experience).

Minimum 4 years of maintenance experience in pharmaceutical, biotech, or life sciences manufacturing, preferably in Oral Solid Dosage (OSD) environments.

Experience supporting equipment qualification and validation activities (IQ/OQ/PQ).

Strong understanding of cGMP, FDA regulations, and pharmaceutical manufacturing standards.

Hands-on troubleshooting experience across mechanical, electrical, pneumatic, and automation systems.

Ability to read and interpret mechanical drawings, electrical schematics, and equipment manuals.

Experience working with CMMS systems for maintenance documentation.

Strong analytical, troubleshooting, and problem-solving skills.

Ability to work both independently and in cross-functional teams.

Preferred Skills

Experience with automation systems (PLC, HMI, SCADA).

Knowledge of HVAC systems, compressed air systems, and manufacturing utilities.

Familiarity with lean manufacturing, reliability engineering, and continuous improvement methodologies.

Eligibility Requirements

Candidates must be one of the following:

US Citizen

Green Card Holder

H1B Transfer Eligible

Interview Process

Round 1: Virtual interview (Microsoft Teams)

Round 2: On-site interview

Additional Information

Background check and drug screening will be required after offer acceptance.

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