Senior Process Engineer, Drug Product

Lantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio.

Lantheus is an entrepreneurial, agile, growing organization that provides innovative diagnostics, targeted therapeutics, and artificial intelligence (AI) solutions that empower clinicians to find, fight and follow disease. At Lantheus our purpose and values guide our behaviors in all interactions and play a vital role in creating a dynamic environment that contributes to our success. Every employee is crucial to our success; we respect one another and act as one knowing that someone’s health is in our hands. We believe in helping people be their best and are seeking to bring together a diverse group of individuals with different viewpoints and skill sets to be a part of a productive and inclusive team.

Job Summary

We are seeking a highly skilled and detail-oriented Sr. Process Engineer with significant drug product visual inspection and labeling experience to join our dynamic team at Lantheus. In this role, you will leverage your experience in quality systems, change management, project management, and process improvements to drive compliance, efficiency, and innovation in the visual inspection and labeling processes. This position requires a strong understanding of regulatory requirements, technical excellence, and the ability to work cross-functionally to support critical business initiatives.

Key Responsibilities

• Act as process owner for visual inspection and labeling processes.
• Critically evaluate process data, develop action plans with internal and external stakeholders to proactively optimize production processes.
• Respond to, resolve, and drive to closure quality events in the visual inspection and labeling processes.
• Own process lifecycle management of critical manufacturing operations
• Collaborate with quality, regulatory, and manufacturing teams to evaluate and execute changes, supporting a first-time right approach.
• Plan, execute, and oversee labeling projects from concept through implementation, ensuring alignment with product launch timelines and regulatory requirements.
• Develop project scopes, timelines, and resource plans to ensure seamless coordination with cross-functional teams.
• Collaborate with Manufacturing, Engineering, and Quality Assurance to maintain image library and data analytics/trending of visual inspection program.
• Provide technical expertise and troubleshooting support for visual inspection and labeling issues, including root cause analysis and corrective action planning.
• Support manufacturing labeling operations including support, issue trending, and improvement projects.
• Serve as key liaison between quality assurance, manufacturing, regulatory affairs, and supply chain to align labeling strategies with overall business objectives.
• Support product launches, updates, and regulatory requirements by coordinating with cross-functional teams to achieve timely and compliant product releases.
  
  

Qualifications

• Education: Bachelor’s degree in Engineering or a related field
• Experience: Minimum of 8 years experience in visual inspection and pharmaceutical labeling in GMP environment with specific expertise in sterile injectables and medical devices
  
  

Other Requirements

• This individual should be a self-starter with the ability to work well both independently and in a team environment.
• Demonstrated technical problem-solving skills with root cause analysis tools.
• Direct experience with project management skills.
• Excellent organizational and time management skills.
• Excellent oral & written communication skills.  Demonstrated ability to write and review technical documents and develop and present technical presentation materials.
• Establishes strong inter-departmental relationships and is viewed as a leader and a valuable technical resource to others.
• Direct experience with aseptic/parenteral pharmaceutical process validation methodologies
• Experience with Code of Federal Regulations parts 210 and 211 and supporting regulatory inspections.
  
  

Lantheus is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Lantheus is an E-Verify Employer in the United States. Lantheus will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Lantheus Talent Acquisition team at talentacquisition@lantheus.com.