Process Engineer II, Manufacturing Process Validation & Equipment Qualification

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.

• 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.