Process Engineer Jobs

About The Position

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 with project management and documentation tools such as Microsoft Project, Visio, and Microsoft Office.
• Willingness to work onsite as required to support manufacturing operations.

Responsibilities

• Serve as technical owner for assigned manufacturing processes, supporting engineering needs 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 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 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 support safe, compliant, and reliable operations.
• Provide process validation support for manufacturing processes, equipment, utilities, automation systems, cleaning, and sterilization during 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 identified risks.
• Ensure validation protocols and reports comply with applicable validation guidelines, cGMP requirements, and global regulatory expectations, including FDA, EMA, and PIC/S.
• Collect, organize, analyze, and evaluate validation data, and communicate progress, issues, and risks to validation management.
• Participate in project team meetings to help 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 revising and creating 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

• 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.
• Discretionary performance-based cash incentive.