The Engineering & Validation Specialist is an entry-level engineering position responsible for supporting Manufacturing, Quality, Regulatory, and Engineering activities through the development and maintenance of technical documentation and execution of engineering studies. The primary focus of this position is technical writing and documentation, including process validation protocols and reports, equipment

IQ/OQ/PQ

documentation, engineering studies, time studies, batch records, work instructions, and other controlled manufacturing documents. The position will work closely with Operations, Quality, Regulatory, Maintenance, and other functional teams to document processes, evaluate equipment and manufacturing performance, and support compliance with applicable GMP and regulatory requirements. The successful candidate will develop a strong understanding of the company's manufacturing processes, equipment, products, and quality systems while gaining practical experience in process validation, equipment qualification, and manufacturing engineering.

PRIMARY DUTIES & RESPONSIBILITIES

Technical Documentation & Writing Author, revise, and maintain technical documents supporting manufacturing, Quality, and Regulatory requirements. Develop and maintain batch records, manufacturing instructions, work instructions, standard operating procedures, and other controlled documents. Prepare clear, accurate, and technically sound documentation based on manufacturing processes and equipment. Work with Operations and Quality to ensure documents accurately reflect current manufacturing practices. Maintain documentation in accordance with applicable document control and GMP requirements. Incorporate approved changes into controlled documents and ensure appropriate review and approval. Process Validation Support the development and execution of process validation protocols and reports. Assist with identifying process parameters, acceptance criteria, sampling requirements, and data collection requirements. Collect and organize validation data and prepare summary reports. Work with Operations and Quality to execute validation activities on the manufacturing floor. Support continued process verification and process monitoring activities. Assist with validation-related deviations, investigations, and corrective actions. Equipment Qualification Support the development and execution of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols and reports. Document equipment requirements, specifications, installation information, and operating parameters. Coordinate with Maintenance, Engineering, Operations, and Quality during equipment qualification activities. Collect and organize qualification data and ensure appropriate documentation is completed. Assist with equipment qualification-related deviations and corrective actions. Engineering Studies & Manufacturing Support Develop and execute engineering studies, time studies, capacity studies, and other manufacturing evaluations. Collect and analyze manufacturing data to support process and equipment decisions. Document study objectives, methodology, results, conclusions, and recommendations. Perform observations and data collection on the manufacturing floor. Assist in evaluating equipment performance, process capability, line rates, downtime, and other operational metrics. Support Engineering and Operations with troubleshooting and process improvement activities. Quality & Regulatory Support Partner with Quality and Regulatory personnel to provide technical documentation and data required to support regulatory and quality activities. Support investigations, CAPAs, change controls, and other quality system activities. Assist with the preparation of technical documentation requested for customer audits and regulatory inspections. Ensure technical documents are accurate, complete, traceable, and supported by objective data. Maintain a working knowledge of applicable cGMP requirements and FDA regulations as they relate to manufacturing documentation and validation. Support preparation of documentation for customer and regulatory review. Manufacturing & Cross-Functional Support Develop a strong understanding of manufacturing processes, equipment, and products. Spend time on the manufacturing floor to understand processes and gather accurate information for technical documentation. Work closely with Operations, Quality, Maintenance, and other departments to identify and document process requirements. Assist with implementation of approved process, equipment, and documentation changes. Participate in project teams and cross-functional improvement initiatives. Perform other duties and projects commensurate with the position as assigned.

EDUCATION & EXPERIENCE

Bachelor's degree in Engineering, including Chemical, Mechanical, Industrial, Manufacturing, Biochemical, or a related engineering discipline. 0-2 years of engineering experience, including internships or co-op experience. Strong technical writing and documentation skills. Ability to interpret technical information, manufacturing processes, equipment specifications, and data. Familiarity with Microsoft Office, particularly Word and Excel. Basic understanding of data analysis and statistical concepts. Familiarity with GMP manufacturing, validation, or regulated manufacturing environments is preferred but not required. Familiarity with statistical tools such as JMP or Minitab is a plus.

KEY COMPETENCIES

Technical Writing & Documentation Excellent written communication and technical writing skills. Strong attention to detail and commitment to documentation accuracy. Ability to translate technical and manufacturing information into clear, concise written procedures and reports. Ability to organize and present technical information logically. Analytical Skills Strong analytical and problem-solving abilities. Ability to collect, organize, and interpret data. Ability to identify trends and discrepancies in data and documentation. Comfortable performing basic calculations and data analysis. Organization & Project Management Ability to manage multiple assignments and meet established deadlines. Strong organizational and follow-through skills. Ability to prioritize work in a changing manufacturing environment. Ability to work independently while recognizing when guidance is needed. Communication & Collaboration Ability to communicate effectively with Operations, Quality, Maintenance, Engineering, and other departments. Comfortable working with manufacturing personnel and gathering information directly from the production floor. Ability to ask questions, seek clarification, and build an understanding of unfamiliar processes. Professional and collaborative approach to problem solving. Learning & Development Demonstrates curiosity and willingness to learn manufacturing processes and equipment. Able to accept direction and incorporate feedback. Demonstrates initiative while recognizing the boundaries of an entry-level role. Willingness to develop knowledge of GMP, validation, and regulated manufacturing requirements.

BASIC SKILLS & CAPABILITIES

Ability to read, write, speak, and understand English. Ability to perform basic mathematical calculations. Ability to read and understand technical documents, drawings, specifications, procedures, and instructions. Ability to use Microsoft Word, Excel, Outlook, and other standard business software. Ability to communicate effectively with coworkers and staff. Ability to work independently or with other team members to accomplish company goals. Ability to exercise good judgment, initiative, and organization. Ability to comprehend and accomplish tasks according to guidance and instructions from Management/Supervision. Ability to work in an office and manufacturing environment. Ability to walk and/or stand for extended periods of time while performing manufacturing floor activities. Ability to lift or move objects when required for job duties. Ability to visually distinguish colors, depth, peripheral vision, and focus under various lighting conditions.

Pay:

$70,000.00 - $75,000.00 per year

Benefits:

401(k) matching Dental insurance Employee assistance program Health insurance Life insurance Paid time off Vision insurance Ability to

Commute:

Royston, GA 30662 (Required)

Work Location:

In person