Kelly is hiring: Technical Director - OTC Manufacturing in Royston

Technical Director - OTC Manufacturing

Seeking a hands-on Technical Operations leader from pharmaceutical or OTC manufacturing environments with strong experience supporting GMP production, equipment optimization, and process validation.

Location: Royston, GA (Onsite) Compensation: $150K$175K

Overview

A growing pharmaceutical manufacturing organization is seeking a Director of Technical Operations to lead plant-facing engineering and technical activities across manufacturing, validation, and technology transfer. This role is responsible for driving process engineering, equipment optimization, and continuous improvement within a cGMP-regulated environment supporting a diverse portfolio including OTC, Rx, medical devices, and consumer products.

This is a hands-on leadership role requiring strong mechanical and process engineering expertise with direct impact on manufacturing performance and operational excellence.

Key Responsibilities

Engineering & Technical Leadership

• Lead process engineering, technical operations, and validation teams supporting manufacturing and packaging
• Drive continuous improvement initiatives focused on equipment performance, process efficiency, and throughput
• Serve as the technical authority for manufacturing operations and engineering activities

Equipment & Manufacturing Operations

• Oversee design, installation, qualification, and optimization of manufacturing and packaging equipment and production lines
• Ensure equipment and processes are operating at optimal efficiency, reliability, and compliance
• Support new product introductions with strong engineering and operational readiness

Technology Transfer & Scale-Up

• Lead end-to-end tech transfer of products into GMP manufacturing environments
• Oversee feasibility, scale-up, validation, and commercial readiness activities
• Ensure smooth integration of new products into existing production lines

Process Optimization & Problem Solving

• Lead root cause investigations, deviation management, and CAPA implementation
• Utilize data, trending, and statistical tools to improve process capability and reduce variability
• Drive process robustness and manufacturing consistency

Validation & Compliance

• Oversee execution of process validation (IQ/OQ/PQ), cleaning validation, and continued process verification
• Ensure all engineering and technical operations comply with cGMP, FDA, and global regulatory requirements
• Support regulatory inspections as a technical SME

Cross-Functional Collaboration

• Partner with Manufacturing, Quality, Engineering, and Supply Chain teams to ensure alignment and execution
• Collaborate with external clients on tech transfer and manufacturing support activities

Qualifications

• Bachelor's degree in Mechanical Engineering, Chemical Engineering, or related field (Mechanical strongly preferred)
• 1015+ years of experience in pharmaceutical, OTC, or consumer product manufacturing
• Strong background in:
  • Process engineering and equipment optimization
  • Technology transfer and scale-up
  • Process validation (IQ/OQ/PQ)
• Proven leadership experience managing plant-facing technical or engineering teams
• Deep knowledge of cGMP, FDA, and regulatory compliance requirements
• Experience in OTC or high-volume manufacturing environments strongly preferred
• Background in CDMO or contract manufacturing environments is a plus

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