Process Engineer II

Lantheus; Billerica (MA); On-site; USD 85,000 - 110,000; Full time

Job summary

A leading company in medical imaging seeks a Process Engineer II to support the production of radiopharmaceutical products. This role involves ensuring compliance with regulatory standards, providing technical support, and collaborating on process improvements. Ideal candidates should have over 6 years of relevant experience in cGMP environments with a background in engineering or a related field.

Qualifications

• 6+ years experience in pharmaceutical manufacturing, particularly in sterile injectables.
• Strong understanding of cGMPs and medical device regulations.
• Demonstrated ability to conduct investigations and document findings.

Responsibilities

• Provide technical support for manufacturing operations.
• Lead investigations for production deviations and implement improvements.
• Collaborate with cross-functional teams on process changes and validations.

Skills

Problem solving

Technical writing

Data analysis

Interpersonal skills

Education

Bachelor’s degree in Chemical Engineering, Mechanical Engineering, Nuclear Engineering, Chemistry

Tools

Excel

TrackWise

CATSWeb

Job description

Join to apply for the Process Engineer II role at Lantheus

Join to apply for the Process Engineer II role at Lantheus

Lantheus is headquartered in Bedford, Massachusetts with offices in 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.

This position site-based and requires a presence on-site 5 days per week.

Position Summary

We are seeking an experienced and driven Process Engineer II to support commercial and clinical manufacturing of radiopharmaceutical drug products. This position plays a critical role in ensuring robust, compliant, and efficient production processes for sterile injectable and device-combination products. The ideal candidate brings 6+ years of hands-on experience in cGMP manufacturing support, with a strong understanding of sterile drug production, radiopharmaceutical workflows, and medical device quality systems.

Key Responsibilities

• Provide day-to-day technical support to manufacturing operations, ensuring reliable production.
• Lead investigations for moderate- to high-complexity deviations, perform root cause analyses, and implement CAPAs in collaboration with QA and operations teams.
• Author and revise controlled documents, including manufacturing documentation, technical reports, protocols (e.g., process validation, equipment qualification), and risk assessments.
• Support process monitoring, trending, and data analysis activities to drive continuous improvement and maintain a state of control.
• Participate in cross-functional teams for process changes, equipment upgrades, and lifecycle projects, ensuring alignment with regulatory and quality requirements.
• Act as a technical contributor in change control execution, including impact assessments, protocol generation, and implementation planning.
• Support and/or lead multiple technical transfers, scale-ups, and process validation activities.
• Collaborate with stakeholders in Manufacturing, QA, QC, Engineering, and Supply Chain to ensure timely and compliant execution of manufacturing campaigns.
• Ensure compliance with applicable regulations, including 21 CFR Parts 210, 211, 820, EU GMP Annex 1, and radiation safety requirements.
• Support readiness activities for internal and regulatory audits, including documentation review and SME participation.
  
  

Qualifications

• Bachelor’s degree in Chemical Engineering, Mechanical Engineering, Nuclear Engineering, Chemistry, or a related technical field (advanced degree preferred).
• 6+ years of experience in pharmaceutical manufacturing, with a strong focus on sterile injectable or radiopharmaceutical production.
• Solid understanding of cGMPs, aseptic processing, cleanroom operations, and medical device/combination product regulations (21 CFR 210, 21 CFR 211, 21 CFR 820, ISO 13485).
• Demonstrated ability to investigate deviations, problem solve, and execute changes within a quality system framework. Advanced technical writing skills required.
• Hands-on experience with equipment commonly used in sterile fill/finish operations.
• Familiarity with process validation, equipment qualification, and risk management principles.
• Self-starter with strong interpersonal and communication skills; able to work independently and in cross-functional teams.
• Proficiency in Excel, data analysis tools, and electronic document/change control systems (e.g., TrackWise, CATSWeb). Skilled at presenting technical content to technical and non-technical audiences.
  
  

Preferred Experience

• Experience in handling radioactive materials or supporting radiopharmaceutical manufacturing environments.
• Knowledge of lean manufacturing principles and process improvement methodologies.
• Experience in lifecycle management of commercially approved pharmaceutical products and devices.
• Experience in managing large cross-functional projects in a matrix environment.
  
  

Work Environment & Physical Requirements

• Work in cleanroom environments and radiation-controlled areas required.
• Some off-shift or weekend coverage may be needed based on production schedules.
  
  

Core Values

The Ideal Candidate Will Embody Lantheus Core Values

• Let people be their best
• Respect one another and act as one
• Learn, adapt, and win
• Know someone’s health is in our hands
• Own the solution and make it happen
  
  

Lantheus is an equal opportunity employer that provides a workplace free from discrimination. All qualified applicants and employees are considered without regard to race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any other characteristic protected by 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 [e-mail].

Seniority level

• Seniority level

  Not Applicable

Employment type

• Employment type

  Full-time

Job function

• Job function

  Management and Manufacturing

• Industries

  Pharmaceutical Manufacturing

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