Process Engineer II, Manufacturing Process Validation & Equipment Qualification

Lantheus • Springfield, NJ

2d • $89,000 - $148,000 • Hybrid

About The Position

Lantheus is seeking a Process Engineer II to provide technical support for pharmaceutical and radiopharmaceutical manufacturing operations throughout the product lifecycle. The role serves as a subject matter expert for manufacturing processes and supports technology transfer, process validation, equipment qualification, investigations, process monitoring, and continuous improvement. The engineer plans, executes, and maintains validation activities and serves as study director for assigned process validation work, ensuring that manufacturing processes, equipment, utilities, automation systems, cleaning, and sterilization processes remain validated and comply with applicable regulatory requirements.

The role works independently and collaborates with Manufacturing, Engineering, Quality, MSAT, and external partners on project execution, inspection readiness, and improvement of the process validation program. The position is based in Springfield, New Jersey, and requires on-site presence three days per week. Applicants must be authorized to work for any employer in the United States.

Requirements

• Bachelor’s degree in engineering, Life Sciences, or a related scientific discipline.
• At least 3 years of process and/or equipment validation experience in the pharmaceutical, biopharmaceutical, or medical device industry.
• Hands-on validation experience with pharmaceutical manufacturing processes and systems, including radiopharmaceutical dispensing systems and radiopharmaceutical synthesizers.
• Knowledge of cGMP requirements, pharmaceutical process validation practices, and change control processes.
• Ability to author clear and compliant technical documentation, including validation protocols, test plans, and reports.

Nice To Haves

• Experience supporting aseptic fill-finish operations and validation of vial filling lines and aseptic manufacturing technologies.
• Strong organizational, analytical, and problem-solving skills.
• Strong verbal and written communication skills, including the ability to present validation strategies and outcomes effectively.
• Ability to work independently and effectively within cross-functional teams.
• Experience using project management and documentation tools such as Microsoft Project, Visio, and Microsoft Office.
• Willingness to work on-site as required to support manufacturing operations.

Responsibilities

• Serve as technical owner for assigned manufacturing processes and provide engineering support 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 documents, engineering studies, investigations, and technical reports; support URS, SIA, design qualification, verification packages, and performance qualification activities.
• Lead and support commissioning, qualification, verification, performance qualification, requalification, and process validation using risk-based validation and good engineering practices.
• Execute process validation activities, including authoring and reviewing protocols, coordinating or executing protocol work, and authoring final validation reports.
• Provide on-floor technical support during engineering, clinical, process validation, and commercial manufacturing campaigns to promote safe, compliant, and reliable operations.
• Provide process validation support for manufacturing processes, equipment, utilities, automation systems, cleaning, and sterilization in routine operations and facility or process change projects.
• Represent Process Validation on cross-functional project teams and provide updates on validation status, schedule adherence, and risks.
• Ensure validation protocols and reports comply with applicable validation guidelines, cGMP requirements, and global regulatory expectations, including FDA, EMA, and PIC/S expectations.
• 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 timelines and business needs.
• Support inspection readiness, participate in regulatory agency inspections, and provide audit support as required.
• Collaborate with Manufacturing, Engineering, Quality, MSAT, contractors, consultants, and vendors to coordinate process validation activities.
• Lead continuous improvement initiatives for the process validation program, including creating and revising validation procedures, templates, and best practices.
• Promote safety rules and awareness and demonstrate good safety practices.
• Demonstrate Lantheus values of accountability, quality, efficiency, customer service, collaboration, and safety.

Benefits

• Discretionary performance-based cash incentive.
• Comprehensive health benefits package including medical, prescription drug, dental, and vision coverage.
• Life and disability benefits.
• Pre-tax accounts.
• 401(k) with company contribution.
• Other benefits.
• Paid vacation, holidays, and sick days.
• Paid parental leave.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level