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 were 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. Were 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 someones 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 crossâfunctional 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

• Bachelors 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 handsâon 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 fillâfinish operations and validation of vial filling lines and aseptic manufacturing technologies is preferred.
• Strong organizational analytical and problemâsolving 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 crossâfunctional 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 someones health is in our hands
• Own the solution and make it happen

The pay range for this position is between $89 000 and $148000 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 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 . 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 teamat .

Lantheus is an E-Verify Employer.

Applicants have rights under Federal Employment Law:Employee Polygraph Protection Act (EPPA);Family and Medical Leave Act (FMLA)
For California Applicants:Family Care & Medical Leave & Pregnancy Disability Leave;California Law Prohibits Workplace Discrimination & Harassment;Your Rights and Obligations as a Pregnancy Employee
For Ohio Applicants:Know Your Rights: Equal Employment Opportunity is the Law

Required Experience:

IC