Validation Engineer

Validation Engineer

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).

Work 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.
• 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.

Requirements

• Bachelors 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. Minimum of two (2) years of validation experience with sterile processes 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.
• Familiarity with Radiopharmaceutical processing is highly preferred.
• 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.

Primary job location is in Noblesville, but occasional travel is required to Missouri to support the qualification activities at our Maryland Heights facility.

Working Conditions: Willingness to work in plant producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels. Responsibilities include the ability to lift up to 70 pounds, kneeling, crouching, twisting the upper body, walking, bending, stooping, pushing, pulling, reaching, must be able to physically negotiate stairs and evacuation ladders with or without accommodation, wear and operate safety equipment, enter vessels, and inspect equipment. Material handling devices (e.g., hand truck, fork truck, and conveyors) are used when possible, however, use of proper lifting and movement techniques is necessary to prevent injury. Must be willing to wear a variety of Personal Protective Equipment (PPE) and hearing protection as needed. May be required to sit or stand for long periods of 8+ hours a day while performing duties. Must possess good hand-eye coordination; close attention to detail is required. Must be able to work indoors and outdoors with exposure to mechanical/moving parts, hazards including corrosive, flammable and toxic material, dust, dirt, odors, and irritants. Willingness to complete safety training within allotted timeframes, and work in a team-based environment. Must be able to work outside of regular work hours, including off shift, weekend, and holiday work as business needs require.