Curium Pharma · 2 days ago
Validation Engineer
Maryland Heights, MO
Full-time
Onsite
Mid Level
3+ years expCurium Pharma is a company focused on pharmaceutical manufacturing and quality control. The Validation Engineer will be responsible for driving compliance and supporting validation projects while establishing risk-based validation strategies to enhance operational excellence in GMP manufacturing and QC Laboratory systems.
Pharmaceutical
Hiring Manager
Michael Gruen
Responsibilities
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, 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
Qualification
Required
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 experience required
Working knowledge of global cGMPs (to include EU standards), Validation Life Cycle and pharmaceutical manufacturing requirements
Familiarity with the Sterile manufacturing and packaging facilities and operations
Results-oriented, able to make decisions and prioritize work per business needs in a fast-paced environment
Strong written and verbal communication skills, problem solving, organization and time management skills
Strong computer competencies including proficiency in Microsoft suite products, statistical software and Quality Documentation Management software
Must be able to travel approximately 25% within US to support validation activities at multiple Curium facilities
Preferred
Familiarity with Radiopharmaceutical processing is highly preferred
Company
Curium Pharma
Curium is a world-class nuclear medicine solutions provider with over 100 years of industry experience.
1001-5000 employees
Funding
Current Stage
Late StageTotal Funding
unknown2017-04-06Acquired
Leadership Team
Benoit Woessmer
CEO PET Europe
Michael Patterson
Chief Executive Officer - North America
Recent News
Curium US LLC
2025-12-03
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