Pharmaceutical Field Service Engineer at SCHMALZ INC – Raleigh-Durham, North Carolina

The Pharmaceutical Field Service Engineer is responsible for installation, preventive maintenance, inspection, calibration support, and repair of Schmalz pharmaceutical material-handling equipment used in GMP manufacturing and cleanroom environments. This role ensures Schmalz equipment remains compliant with FDA and GMP requirements and supports customer audits and validation activities. This position interfaces directly with production, maintenance, validation, and quality assurance teams at pharmaceutical manufacturing facilities. The role is based out of Raleigh but requires extensive travel to customer sites throughout the US. This position reports directly to the VP of Operations. Candidates must live in the Raleigh-Durham area.

Position Overview:

• Perform pre-installation assembly & customer FAT activities.
• Perform installation, commissioning, and training activities at customer location(s).
• Perform Preventive Maintenance (PM), inspection, troubleshooting, and repair.
• Complete inspections according to GMP and FDA requirements and compliant with:
• 21 CFR Part 211?(GMP manufacturing equipment suitability & maintenance records)
• 21 CFR Part 11?(electronic records & audit trails where applicable)
• Follow cleanroom and contamination-control procedures per ISO 14644 Cleanroom Standards.
• Maintain traceable maintenance records and service reports.
• Ensure equipment remains serviceable for validated processes.
• Provide customer recommendations for corrective actions and preventive maintenance.
• Diagnose mechanical, electrical, and pneumatic faults.
• Replace normal wear components during service visits.
• Verify safety interlocks and overload protections.
• Perform functional testing and operational verification.
• Support installation and commissioning at customer sites.

Documentation & Reporting:

• Complete detailed service reports, deviation reports, and inspection forms.
• Record parts used and service activities in CMMS or service system.
• Write technical findings in audit-defensible language.
• Provide maintenance recommendations and lifecycle assessments.

Customer Support:

• Serve as the primary on-site technical contact.
• Support maintenance and operators with troubleshooting and training.
• Provide operator training on proper use and inspection of lifting equipment.
• Assist customers during regulatory audits and quality investigations.

Basic Qualifications (Including Educational Requirements):

• Associate or bachelor’s degree in mechanical, electrical, mechatronics, or related field.
• 3-7+ years’ experience of hands-on field service, maintenance, or validation support.
• Experience servicing pharmaceutical material handling and lifting equipment.
• Strong troubleshooting skills (mechanical & electrical).
• Ability to read drawings, wiring diagrams, and pneumatic schematics.

Preferred Experience:

• Pharmaceutical, biotech, or regulated manufacturing experience Knowledge of GMP documentation practices, deviation/CAPA awareness, equipment qualification (IQ/OQ/PQ).
• Experience working in cleanrooms and gowning procedures.
• Familiarity with load cells, VFDs, PLC-controlled equipment, and safety circuits.
• Prior exposure to audits (FDA or customer).

Physical Requirements:

• Ability to lift 50 lbs.
• Work on ladders, lifts, and production floors.
• Able to gown and work in cleanroom environments for extended periods.

Company Benefits:

• Excellent compensation package, including a 10% annual bonus.
• Generous car and communication allowance plan.
• Schmalz pays over 85% of medical benefits.
• 401k plan with a 6% company match; funds are 100% vested.
• Paid time off benefits starting first day of employment.

Who are we? Check us out on our company website at: www.schmalz.com