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 710 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.