Process Engineer II, Manufacturing Process Validation & Equipment Qualification

Lantheus (NASDAQ: LNTH) is the leading radiopharmaceutical-focused company, delivering life-changing science to enable clinicians to Find, Fight and Follow disease to deliver better patient outcomes. Headquartered in Massachusetts with offices in New Jersey, Canada, Germany, Sweden, Switzerland and United Kingdom, Lantheus has been providing radiopharmaceutical solutions for nearly 70 years.

Today, we're expanding our portfolio and pipeline across oncology, neurology and cardiology. Through recent acquisitions, along with strategic partnerships across the life sciences ecosystem, we are accelerating our efforts to advance precision medicine and improve patient outcomes around the world.

At Lantheus we are purpose-driven, and every employee plays a vital role in our success. We're dedicated to cultivating a high-growth, forward-thinking culture where innovation thrives and diverse perspectives drive meaningful progress.

Join us and be part of a company where your contributions make a real impact, because we know someone's health is in our hands.

Summary of role

We are seeking a Process Engineer II who will be responsible for providing technical support for pharmaceutical and radiopharmaceutical manufacturing operations throughout the product lifecycle. This role serves as a subject matter expert for manufacturing processes, supporting technology transfer, process validation, equipment qualification, investigations, process monitoring, and continuous improvement initiatives. The Process Engineer II is responsible for planning, executing, and maintaining validation activities to support pharmaceutical and/or radiopharmaceutical manufacturing operations. This role acts as a study director for assigned process validation activities and ensures manufacturing processes, equipment, utilities, automation systems, cleaning, and sterilization processes remain in a validated state and compliant with applicable regulatory requirements.

The Process Engineer II works independently while collaborating closely with Manufacturing, Engineering, Quality, MSAT, and external partners to support project execution, inspection readiness, and continuous improvement of the process validation program.

This position is based in Springfield, New Jersey and requires a presence on-site three days per week, and open to applicants authorized to work for any employer within the United States.

Responsibilities

• Serve as the technical owner for assigned manufacturing processes, providing engineering support throughout the product lifecycle from technology transfer through commercial manufacturing.
• Support the design, implementation, qualification, and lifecycle management of manufacturing equipment, utility systems, automation systems, and facility infrastructure used in GMP operations.
• Author and review technical documentation including system definitions, user requirements, risk assessments, qualification and validation documentation, engineering studies, investigations, and technical reports. The role would support creation of URS, SIA, risk assessments, design qualifications, verification packages, and performance qualification activities.
• Lead and support commissioning, qualification, verification, performance qualification, requalification, and process validation activities using risk-based validation and good engineering practices.
• Responsible for execution of process validation activities, including authoring and reviewing validation protocols, coordinating and/or executing protocol execution, and authoring final validation reports.
• Provide on-floor technical support during engineering, clinical, process validation, and commercial manufacturing campaigns to ensure safe, compliant, and reliable execution of manufacturing operations.
• Provide process validation support for manufacturing processes, equipment, utilities, automation systems, cleaning, and sterilization to support routine operations and facility or process change projects.
• Represent the Process Validation function on cross‑functional project teams and provide regular updates on validation status, schedule adherence, and identified risks.
• Ensure validation protocols and reports are developed, executed, and approved in compliance with applicable validation guidelines, cGMP requirements, and global regulatory expectations (e.g., FDA, EMA, PIC/S).
• Independently collect, organize, analyze, and evaluate validation data and communicate progress, issues, and risks to validation management.
• Participate in project team meetings to ensure validation activities meet established timelines and support business needs.
• Support inspection readiness activities, participate in regulatory agency inspections, and provide audit support as required.
• Collaborate effectively with Manufacturing, Engineering, Quality, MSAT, contractors, consultants, and vendors to ensure coordinated execution of process validation activities.
• Lead continuous improvement initiatives for the process validation program, including revision and creation of validation procedures, templates, and best practices.
• Actively promote safety rules and awareness and demonstrate good safety practices at all times.
• Actively demonstrate Lantheus values of accountability, quality, efficiency, customer service, collaboration, and safety.

Basic 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 the pharmaceutical, biopharmaceutical, or medical device industry.
• Demonstrated hands‑on validation experience with pharmaceutical manufacturing processes and systems including radiopharmaceutical dispensing systems and radiopharmaceutical synthsizers.
• Demonstrated knowledge of cGMP requirements, pharmaceutical process validation practices, and change control processes.
• Proven ability to author clear and compliant technical documentation, including validation protocols, test plans, and reports.

Preferred Qualifications

• Experience supporting aseptic fill‑finish operations and validation of vial filling lines and aseptic manufacturing technologies is preferred.
• Strong organizational, analytical, and problem‑solving skills.
• Strong verbal and written communication skills, including the ability to effectively present validation strategies and outcomes.
• Demonstrated ability to work independently and effectively within cross‑functional teams.
• Experience using project management and documentation tools (e.g., Microsoft Project, Visio, Microsoft Office) is a plus.
• Willingness to work onsite as required to support manufacturing operations.

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

The pay range for this position is between $89, 000 and $148,000 annually.

Actual base pay offered may vary depending on a number of factors such as job-related knowledge, skills and experience. Employees in this position are eligible for a discretionary performance-based cash incentive. Benefits for this position include a comprehensive health benefits package that includes medical, prescription drug, dental, and vision coverage. Other offerings include life and disability benefits, pre-tax accounts, a 401(k) with company contribution, and a variety of other benefits. In addition, employees are eligible for a generous time off package including paid vacation, holidays, sick days, and paid parental leave. Interested candidates can apply at Lantheus.com. Applications for this position will be accepted until December 4, 2026.

Lantheus is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a persons actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression, sexual orientation, marital status, military service and veteran status, disability, protected medical condition as defined by applicable state or local law, genetic information, or any characteristic protected under applicable federal, state, or local laws and ordinances.

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.

Lantheus is an E-Verify Employer.

Applicants have rights under Federal Employment Law: Employee Polygraph Protection Act (EPPA); Family and Medical Leave Act (FMLA)

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