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Validation & Engineering Group, Inc. · 4 months ago

ATL01-090425 Process & Serialization Engineer (PA)

Allentown, PA

Full-time

Onsite

Mid, Senior Level

3+ years exp

Validation & Engineering Group, Inc. (V&EG) is a leading technical services provider specializing in high-quality services for the Biotechnology and Pharmaceutical industries. They are seeking a Process & Serialization Engineer to support engineering initiatives, serialization systems, and process optimization to enhance efficiency, quality, and compliance in pharmaceutical operations.

BiotechnologyConsultingProfessional ServicesQuality Assurance

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

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

Qualification

Serialization systemsLean ManufacturingSix SigmaTechnical writingOptelTracelinkCodesoftMechanical aptitudeProcess improvementTrainingCommunication skillsMentoringProject management

Required

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