ATL01-090425 Process & Serialization Engineer (PA)

Validation & Engineering Group, Inc. (V&EG) is a leading technical services provider specializing in high-quality Commissioning & Qualification, Validation, Compliance, Quality Assurance, and Engineering services for the Biotechnology, Pharmaceutical, Advanced Therapies, Medical Device, and Chemical (API) industries.

We are seeking a talented, dedicated individual committed to working under the highest ethical standards for the following position:

• Process & Serialization Engineer

Position Overview:
We are seeking a Process Engineer with expertise in process improvement, serialization, and GMP manufacturing environments. This role will support engineering initiatives, serialization systems, and process optimization to enhance efficiency, quality, and compliance in pharmaceutical operations.

Responsibilities:

• Establish a strong focus on long-term continuous improvement activities through collaboration with Engineering and Operations staff.
• Recommend and implement methods to improve efficiency and reduce waste, including workflow redesign, workstation/equipment relocation, and adoption of new technologies.
• Collaborate with Production to address workflow barriers and increase throughput.
• Drive engineering project initiatives to increase machine speeds, reduce labor hours, and minimize reject rates.
• Conduct deviation investigations, change controls, and corrective/preventive actions.
• Standardize machine setups to maximize run speed, quality, and consistency.
• Lead cost-saving initiatives aligned with business objectives and technology investments.
• Utilize Lean, Six Sigma, SMED, and PPI methodologies to improve processes.
• Support technology transfer activities to onboard new and existing clients according to project timelines.
• Develop and maintain technical documentation, including project schedules, specifications, protocols, SOPs, and work instructions.
• Coordinate multiple project tasks from inception to completion using sound project management practices.
• Ensure compliance with GMPs, Good Manufacturing Principles, and company standards of Integrity, Intensity, Innovation, and Involvement.
• Conduct all activities safely and efficiently.

Serialization-Specific Responsibilities:

• Support client onboarding and connectivity activities, including master data coordination.
• Develop and configure Optel recipes for production, integrating client data and label layouts.
• Create and approve serialization labels using Codesoft labeling software.
• Lead testing and validation of serialization equipment and system connectivity.
• Support setup, qualification, and ongoing production use of serialization equipment.
• Learn and master internal systems such as Tracelink, Codesoft, Trackwise, and eDMS.

Requirements/Skills:

• Bachelor of Science degree in Packaging, Mechanical, Electrical Engineering, or related field, with at least 3 years of relevant experience; and/or 7–10 years of equivalent GMP, pharmaceutical, or food industry experience.
• Strong analytical and problem-solving skills with proven ability to manage multiple priorities.
• Proficiency in Lean Manufacturing, Six Sigma, and PPI methodologies.
• Solid baseline of mechanical aptitude (testing may be required).
• Strong technical writing skills; experience with change controls, specifications (URS/FRS/DS), FMEAs, commissioning protocols, SOPs, and work instructions.
• Excellent communication skills (written and verbal), with ability to interact effectively with clients and present technical information.
• Proficient in MS Office applications; advanced Excel and statistical software (e.g., Minitab) preferred.
• Knowledge of pharmaceutical packaging materials and equipment.
• Experience with process improvement and industrial design applications in job-shop or batch manufacturing environments.
• Skilled at training, mentoring, and collaborating with cross-functional teams.
• Proficiency with serialization systems (Optel, Tracelink, Codesoft) strongly preferred.