MSAT Process Engineer II

About the Company

Lantheus (NASDAQ: LNTH) is the leading radiopharmaceutical-focused company, delivering life-changing science to enable clinicians to Find, Fight and Follow disease for better patient outcomes. Headquartered in Massachusetts with offices in New Jersey, Canada, Germany, Sweden, Switzerland, and the United Kingdom, Lantheus has provided radiopharmaceutical solutions for nearly 70 years. The company is expanding its portfolio and pipeline across oncology, neurology, and cardiology through acquisitions and strategic partnerships to advance precision medicine globally.

Lantheus fosters a high-growth, forward-thinking culture where innovation thrives and diverse perspectives drive progress. Employees play a vital role in the company’s success, contributing to meaningful impact in healthcare.

About the Role

The ideal candidate will have a strong background in assessing and processing quality events, including deviations, CAPA plans, and investigations. This role involves collaborating across multiple teams to guide and execute projects, optimize processes, and manage changes related to components, raw materials, and packaging. The individual will support Procurement in addressing supply shortages and serve as a subject matter expert for aseptic processes, components, and visual inspection.

This position is based in Billerica, MA, requires on-site presence, and is open to applicants authorized to work for any employer in the United States.

Responsibilities

• Provide day-to-day technical support to manufacturing operations to ensure 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, and EU GMP Annex 1.
• Support readiness activities for internal and regulatory audits, including documentation review and SME participation.
• Actively demonstrate Lantheus’ core values.

Requirements

• 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 focus on sterile injectable or radiopharmaceutical production.
• Solid understanding of cGMPs, aseptic processing, cleanroom operations, and medical device/combination product regulations (21 CFR 210, 211, 820, ISO 13485).
• Demonstrated ability to investigate deviations, problem-solve, and execute changes within a quality system framework.
• Advanced technical writing skills.
• 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.
• Expertise with GMP documentation requirements in a regulated environment.

Other Requirements

• Work in cleanroom environments required.
• Some off-shift or weekend coverage may be needed based on production schedules.
• Proficiency with Microsoft Word, Excel, PowerPoint, and Project is required.
• Must exhibit high levels of personal integrity, quality, and professionalism when representing Lantheus externally.
• Travel may be required, including overnight travel to Lantheus and CMO locations, dictated by product needs and project deliverables.

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.

Pay

The pay range for this position is between $89,000 and $148,000 annually. Actual base pay offered may vary depending on job-related knowledge, skills, and experience. Employees in this position are eligible for a discretionary performance-based cash incentive and, depending on the role level, may also be eligible for a discretionary annual equity award.

Benefits

• Comprehensive health benefits package, including medical, prescription drug, dental, and vision coverage.
• Life and disability benefits.
• Pre-tax accounts (e.g., FSA, HSA).
• 401(k) with company contribution.
• Generous time off package, including paid vacation, holidays, sick days, and paid parental leave.