Writes and executes validation plans and protocols. Performs qualification and validation status assessments. Provides validation support to cross-functional project teams to ensure radiopharmaceutical manufacturing and packaging / labeling processes and support systems are in compliance with company validation guidelines and current industry practices.
Key Responsibilities/Essential Functions
- Act as study director responsible for driving the completion of validation activities, including writing and reviewing protocols, executing and/or coordinating protocol execution, and writing final reports.
- Provide guidance and assistance as needed to resolve sterilizer and control temperature chamber requalification issues, assuring timely and clear communication to stakeholders and assistance with documentation of events in the Quality Management System (QMS).
- Represent Validation Group on project teams and report progress and adherence to the schedule, as required.
- Ensure proper validation protocols and reports are developed and followed to ensure compliance with LMI validation guidelines, pharmaceutical industry requirements and regulations (e.g., FDA, EMA, PIC/s).
- Work independently to collect, organize and evaluate validation data and keep validation management informed of progress and any obstacles.
- Proactively review validation status of current equipment, systems, utilities and facilities in order to perform documented periodic validation assessments, risk analyses and identify remedial activity.
- Support inspection readiness, participate in regulatory agency inspections and provide audit support, as required.
- Build a strong working relationship with other departments and contribute to a high performance culture.
- Collaborate well with project team and work efficiently in a team environment. Communicate effectively with management, contractors, validation consultants and vendors.
- Actively promote safety rules and awareness. Demonstrates good safety practices at all times including the appropriate use of protective equipment. Report and take initiative to correct safety & environmental hazards.
- Actively demonstrate the Lantheus values of accountability, quality, efficiency, customer service, collaboration and safety.
- BS degree in science or engineering and a minimum of 5 years validation experience in the pharmaceutical, biopharmaceutical or medical device industry.
- Demonstrated proficiency and knowledge of cGMPs, pharmaceutical industry validation practices, and change control practices required.
- Hands on validation experience with pharmaceutical manufacturing equipment, including sterilizers and depyrogenation ovens, equipment and component cleaning, controlled environments and pharmaceutical utilities.
- Demonstrated ability to effectively write technical documents, including test plans, protocols and reports.
- Strong organization and communication skills along with sufficient computer skills to effectively work with documentation applications such as Microsoft Word and Excel.
- Demonstrated ability to work independently and in cross-functional teams.
- Knowledge of project management tools is a plus.