Engineer, Process

Vytalogy Wellness, LLC•Haslet, TX

5h•$80,000 - $100,000

About The Position

The process engineer role leads the design, optimization, validation, and continuous improvement of complex manufacturing processes in regulated environments such as nutritional production. This role provides technical leadership, ensures regulatory compliance (FDA, GMP, ISO 13485), and drives operational excellence, product quality, and cost efficiency. This role serves as a subject matter expert (SME) and mentors’ other roles while collaborating cross-functionally to support business objectives.

Requirements

Bachelor’s degree in Business Administration, Engineering, Operations Management, or a related field (Master’s degree preferred).
7+ years of experience in process improvement, operational excellence, or related leadership roles required.
Professional certification in Lean, Six Sigma (Green Belt or Black Belt), or equivalent required.
Proven track record of leading successful improvement projects with measurable outcomes.
Strong analytical skills with the ability to interpret complex data and translate insights into actionable strategies.
Exceptional communication, facilitation, and interpersonal skills, with the ability to influence at all organizational levels.
Deep understanding of GMP, FDA regulations, ISO standards, and quality systems and experience with automation, process control systems, or MES.

Nice To Haves

4+ years of experience in regulated manufacturing (medical device, pharmaceutical, or nutraceutical) preferred.

Responsibilities

Design, develop, and continuously improve manufacturing processes, equipment, and technologies to ensure safety, quality, efficiency, and scalability.
Serve as the technical Subject Matter Expert (SME) for critical manufacturing processes, equipment, and automation systems.
Ensure compliance with FDA, GMP, ISO 13485, and other applicable regulatory requirements; support internal and external audits.
Lead process and equipment validation activities, including IQ/OQ/PQ, and support commissioning and qualification efforts.
Oversee new product introduction (NPI), technology transfer, and scale-up from R&D through commercial manufacturing.
Drive deviation management, CAPA development and effectiveness, and continuous compliance initiatives.
Lead complex root cause investigations using structured problem-solving methodologies (e.g., DMAIC, 8D, Fishbone, 5 Whys).
Develop, maintain, and improve SOPs, batch records, and controlled manufacturing documentation.
Drive continuous improvement initiatives using Lean, Six Sigma, SPC, and data-driven analysis to reduce variability, improve process capability (Cp/Cpk), increase yield, and optimize throughput.
Monitor and improve manufacturing KPIs, including OEE, scrap rate, cycle time, and overall productivity.
Lead capital projects, including equipment selection, procurement, installation, commissioning, and qualification.
Evaluate and implement automation, digitalization, and advanced process control solutions to enhance manufacturing performance.
Assess supplier and contract manufacturer processes and support vendor qualification activities, as required.
Lead risk management activities, including FMEA, hazard analysis, and control plans, to ensure product safety and compliance.
Identify, analyze, and redesign manufacturing and business processes to eliminate waste, reduce cost, and improve safety and quality.
Design and deliver training programs to build internal capability in continuous improvement and manufacturing excellence.
Support team development through coaching, mentoring, and knowledge sharing to strengthen technical expertise and succession planning.