Process Engineer II – Validation & Equipment Qualification

Lantheus Brand; Springfield (NJ); Hybrid; USD 89,000 - 148,000; Full time

Job summary

Lantheus is seeking a Process Engineer II for their Springfield, New Jersey site. The role provides technical support for pharmaceutical and radiopharmaceutical manufacturing across the product lifecycle and serves as a subject matter expert in validation, tech transfer, and process monitoring.

The successful candidate will collaborate with Manufacturing, Engineering, Quality, MSAT, and external partners, while maintaining validated state of processes, equipment, and utilities.

Qualifications

• Bachelor’s degree in engineering, Life Sciences, or a related scientific discipline.
• Minimum of 3+ years of process and/or equipment validation experience in pharma/biopharma/medical devices.
• Hands-on validation experience with pharmaceutical manufacturing processes and systems including radiopharmaceutical dispensing systems.

Responsibilities

• Serve as technical owner for assigned manufacturing processes through tech transfer to commercial manufacturing.
• Support design, qualification, and lifecycle management of equipment, utilities, automation, and facility infrastructure in GMP operations.
• Author and review validation documentation, URS, risk assessments, and qualification/validation reports.
• Lead commissioning, qualification, verification, and performance qualification activities with risk-based validation practices.
• Execute process validation protocols and final reports, coordinating protocol execution.
• Provide on-floor technical support during campaigns to ensure safe, compliant manufacturing operations.
• Support validation activities for processes, equipment, utilities, automation, cleaning, and sterilization.
• Represent Validation in cross-functional teams and report risks and progress regularly.
• Ensure protocols/reports meet cGMP and global regulatory expectations (FDA, EMA, PIC/S).
• Participate in inspection readiness and regulatory inspections as required.
• Promote continuous improvement and update validation procedures and templates.
• Demonstrate safety and uphold Lantheus values in daily work.

Skills

Verbal communication

Written communication

Analytical skills

Problem-solving

Education

Bachelor’s degree in engineering or Life Sciences

Tools

Microsoft Project

Visio

Microsoft Office

Job description

Lantheus is seeking a Process Engineer II for their Springfield, New Jersey site. The role provides technical support for pharmaceutical and radiopharmaceutical manufacturing across the product lifecycle and serves as a subject matter expert in validation, tech transfer, and process monitoring.

The successful candidate will collaborate with Manufacturing, Engineering, Quality, MSAT, and external partners, while maintaining validated state of processes, equipment, and utilities.