City
Flowery Branch

State
GA

Job Type
Contract Full-Time

Job Description

Project Overview

The client is building its first US manufacturing operation for an automated drug delivery combination product (auto injector). The program includes two highly automated assembly lines responsible for producing commercial medical devices utilizing vision inspection, force and displacement measurement, robotics, automated testing, and serialization.

The project is currently behind schedule due to significant challenges with one of the assembly machines, creating an immediate need for an experienced Automation / TMV Engineer capable of operating independently in a fast paced startup manufacturing environment.

This is not a traditional validation role. The successful consultant will function as a technical owner of assigned equipment while partnering with Automation, Validation, Quality, Mechanical Engineering, and Manufacturing to stabilize equipment, develop TMV methodologies, and accelerate production readiness.

Position Summary

Seeking a hands on Automation / TMV Engineer with strong mechanical and automation troubleshooting experience in highly automated medical device or pharmaceutical manufacturing environments.

This individual must be comfortable working directly on the production floor, diagnosing equipment issues, supporting programming modifications, executing TMV protocols, and driving equipment readiness under aggressive timelines.

The ideal consultant combines automation, mechanical, and validation expertise and has experience commissioning sophisticated assembly equipment used in regulated manufacturing.

Primary Responsibilities

  • Independently assume ownership of assigned automated assembly equipment.
  • Develop and execute Test Method Validation protocols.
  • Create TMV methodologies for new inspection and measurement systems.
  • Evaluate Measurement System Analysis strategies appropriate for each inspection method.
  • Validate vision systems, force measurement systems, displacement monitoring, color detection, and assembly verification methods.
  • Develop statistically sound TMV acceptance criteria.
  • Execute MSA studies supporting regulatory validation.
  • Review and improve existing TMV documentation.
  • Support startup, troubleshooting, commissioning, and equipment stabilization.
  • Partner with Controls Engineers to verify PLC programming modifications.
  • Verify alarms, interlocks, permissives, sequence logic, and fault recovery.
  • Perform regression testing following programming changes.
  • Support FAT, SAT, IQ, OQ, PQ, and equipment readiness.
  • Assist with schedule recovery while maintaining GMP compliance.
  • Work closely with Automation, Quality, Validation, Manufacturing, and Maintenance.

Required Experience

  • Candidates should possess at least seven years supporting regulated automated manufacturing environments with demonstrated experience in:

    • Automated assembly equipment
    • Medical device, pharmaceutical, or biotechnology manufacturing
    • Equipment startup
    • Commissioning
    • Automation troubleshooting
    • PLC based manufacturing systems
    • Test Method Validation
    • Measurement System Analysis
    • FAT, SAT, IQ, OQ, PQ
    • Root cause investigations
    • Change control
    • Production support

Preferred Industry Experience

Strong preference for candidates from:

  • Medical Device Manufacturing
  • Pharmaceutical Manufacturing
  • Drug Delivery Devices
  • Combination Products
  • Injectable Device Manufacturing
  • Regulated GMP Manufacturing

Preferred Equipment Experience

Experience supporting one or more of the following:

  • Auto injector assembly equipment
  • Medical pen assembly systems
  • Multi station rotary assembly machines
  • High speed automated assembly lines
  • Vision inspection systems
  • Leak testing systems
  • Functional testing stations
  • Precision electromechanical assembly equipment
  • Packaging automation
  • Custom OEM assembly equipment

Preferred Technical Background

Experience with:

  • PLC controlled automation systems
  • Allen Bradley
  • Siemens
  • Servo motion systems
  • HMI troubleshooting
  • Industrial robotics
  • Vision inspection
  • Mechanical assembly systems
  • Root cause analysis
  • FAT
  • SAT
  • TMV
  • IQ
  • OQ

Soft Skills

  • Strong troubleshooting mindset
  • Patient and methodical problem solver
  • Comfortable working in ambiguous startup environments
  • Self directed
  • Detail oriented
  • Collaborative with engineering and manufacturing teams
  • Sense of urgency without sacrificing quality

Success Factors

The successful consultant must be able to:

  • Work independently with minimal supervision.
  • Quickly understand complex automation systems.
  • Learn equipment station by station.
  • Take ownership of assigned equipment.
  • Develop TMV methodologies, not simply execute existing protocols.
  • Make sound engineering decisions despite incomplete documentation.
  • Balance validation requirements with aggressive production schedules.
  • Communicate effectively with cross functional engineering teams.
  • Thrive in a startup manufacturing environment where processes continue to evolve.

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