Validation Engineer

Select how often (in days) to receive an alert:

Maryland Heights, MO, United States, 63043

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. Our proven heritage combined with a pioneering approach are the hallmarks to deliver innovation, excellence and unparalleled service.

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. The name ‘Curium’ honors the legacy of pioneering radioactive researchers Marie and Pierre Curie, after whom the radioactive element curium was named and emphasizes our focus on nuclear medicine. The tagline ‘Life Forward’ represents our commitment to securing a brighter future for all those we serve:
An enhanced quality of care for our patients. A trusted partner to our customers. A supportive employer to our valued team.

The Validation Engineer is responsible for driving compliance, supporting validation projects and establishing risk-based validation strategy to enhance efficiency, regulatory, compliance and operational excellence including Data Integrity for GMP manufacturing and QC Laboratory systems at multi facilities of Curium located in North America. The candidate will support the execution of validation activities for one or more of the following areas:
Cleaning Validation and Facility, Utility, Equipment, and System Qualification (CTUs, RABS, Isolators, Fill-Finish Lines, Lyophilization, Autoclaves, Vial Washers, Dehydrogenation ovens, Visual Inspection and Packaging Labelers, WFI, Clean Steam, HVAC, Dehumidifiers).

Schedule:
Monday – Friday 8am – 5pm

• Ensure a safe and quality working environment through training, awareness, and compliance to safety guidelines, policies and procedures.
• Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. 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 including but not limited to: 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, Val Probe, 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.

• Bachelor Degree in related life sciences or Engineering required. Work experience will be considered in lieu of degree.
• Three (3) or more years of relevant…