Process Engineer II: Validation & Equipment Qualification

Lantheus; Springfield (NJ); On-site; USD 89,000 - 148,000; Full time

Benefits offered by this job

Health benefits

401(k) plan

Paid time off

Parental leave

Job summary

Lantheus, a leading radiopharmaceutical company, seeks a Process Engineer II to provide technical support for pharmaceutical and radiopharmaceutical manufacturing across the product lifecycle. You will serve as a subject matter expert for processes, supporting technology transfer, validation, equipment qualification, investigations, process monitoring, and continuous improvement initiatives.

The role is based in Springfield, NJ with on-site presence three days per week.

Qualifications

• Bachelor’s degree in engineering, life sciences, or related field.
• 3+ years of process and/or equipment validation experience in pharma/biopharma/medical devices.
• Hands-on validation experience with pharmaceutical manufacturing processes and systems.
• Knowledge of cGMP and change control processes.
• Ability to author clear, compliant technical documentation.

Responsibilities

• Serve as the technical owner for assigned manufacturing processes through the product lifecycle.
• Design, implement, qualify, and manage lifecycle of equipment, utilities, automation, and facility infrastructure.
• Author and review validation documentation and risk assessments.
• Lead commissioning, qualification, verification, and process validation activities.
• Execute validation protocols and author final validation reports.
• Provide on-floor technical support during campaigns to ensure compliant operations.
• Support validation for processes, equipment, utilities, automation, cleaning, and sterilization.
• Represent validation on cross-functional teams and report status and risks.
• Ensure protocols/reports comply with validation guidelines, cGMP, and regulatory expectations.
• Collect, analyze, and communicate validation data and progress to management.
• Participate in project meetings to meet timelines and business needs.
• Support inspection readiness and regulatory audits as required.
• Collaborate with Manufacturing, Engineering, Quality, MSAT, contractors, and vendors.
• Lead continuous improvement for the validation program and update procedures.
• Promote safety and demonstrate Lantheus values.

Skills

Process validation

Documentation

cGMP knowledge

Problem solving

Cross-functional collaboration

Education

Bachelor’s degree in engineering or life sciences

Tools

Microsoft Project

Visio

Microsoft Office

Job description

Lantheus, a leading radiopharmaceutical company, seeks a Process Engineer II to provide technical support for pharmaceutical and radiopharmaceutical manufacturing across the product lifecycle. You will serve as a subject matter expert for processes, supporting technology transfer, validation, equipment qualification, investigations, process monitoring, and continuous improvement initiatives.

The role is based in Springfield, NJ with on-site presence three days per week.