Validation Engineer

About Curium

Curium is the world's largest nuclear medicine company with more than a century of industry experience. We develop, manufacture and distribute world-class radiopharmaceutical products to help patients around the globe.

With manufacturing facilities across Europe and the United States, Curium delivers SPECT, PET and therapeutic radiopharmaceutical solutions for life-threatening diseases to over 14 million patients annually.

Summary of Position

The Validation Engineer is responsible for driving compliance, supporting validation projects and establishing a risk-based validation strategy to enhance efficiency, regulatory compliance, and operational excellence including Data Integrity for GMP manufacturing and QC Laboratory systems at multiple Curium facilities in North America.

Schedule : Monday – Friday 8am – 5pm

Essential Functions

• Ensure a safe and quality working environment through training, awareness, and compliance to safety guidelines, policies and procedures.
• Maintain operational compliance with US and international regulatory agencies and guidelines (FDA, EU, HC, TGA, PIC / S, ISO, USP, NRC, cGMP, etc.).
• Track and communicate progress of work against milestones.
• Hands-on experience or knowledge of cleaning visual inspection, swabbing and rinse sampling of CIP systems or manufacturing equipment.
• Support authoring and execution of validation life cycle activities such as URS, criticality assessments, risk assessments, FAT, SAT, IOPQ, PPQ, CSV, CV, PV, periodic reviews and re-qualifications for new and existing equipment, facilities and utilities in a pharmaceutical manufacturing and packaging environment.
• Drive project management efforts for validation activities including project resource estimating, scheduling, risk assessment and overall coordination with cross-functional teams (R&D, Operations, Laboratory and Engineering).
• Collect and review validation data and create validation summary reports including generation of exceptions or deviations, as needed.
• Hands-on experience with Kaye Validator, ValProbe or Ellab temperature mapping equipment.
• Generate and review Change Control documents, site validation documents, and site standard operating procedures.
• Maintain current knowledge of federal and state regulations regarding validation and cGMPs and proactively champion validation initiatives to meet same.
• Assist in training and development of validation personnel.
• Perform periodic SOP review and revisions to assure alignment with corporate and regulatory requirements.
• Coordinate or author investigations to determine root causes and actively participate to develop and propose changes to prevent reoccurrence of issues.
• Support the validation function during internal and external audits, providing expert insights and quick resolution to observations or deviations.
• Must be able to travel approximately 25% within US to support validation activities at multiple Curium facilities.

Requirements

Working Conditions

Disclaimer

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.

Equal Opportunity Employer

Curium is an equal opportunity employer and believes everyone deserves respect, dignity and equality. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

Job Segment

Compliance, Facilities, Nuclear Engineering, Medical Technologist, Pharmaceutical, Legal, Operations, Engineering, Healthcare, Science

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