Validation Engineer

Position Summary

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. This includes managing Data Integrity for GMP manufacturing and QC Laboratory systems at multi-facility operations 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, Depyrogenation ovens, Visual Inspection and Packaging Labelers, WFI, Clean Steam, HVAC, Dehumidifiers).

Work Schedule: Monday – Friday, 8:00 AM – 5:00 PM
Primary Location: Noblesville, IN (with approximately 25% domestic travel required to support qualification activities at other company facilities).

Essential Functions
Ensure a safe and quality working environment through training, awareness, and compliance with safety guidelines, policies, and procedures.
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 the progress of work against milestones.
Apply 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 R&D, Operations, laboratory, and Engineering).
Collect and review validation data and create validation summary reports, including the generation of exceptions or deviations as needed.
Utilize temperature mapping equipment (such as Kaye Validator, ValProbe, or Ellab).
Generate and review Change Control documents, site validation documents, and site Standard Operating Procedures (SOPs).
Maintain current knowledge of federal and state regulations regarding validation and cGMPs and proactively champion validation initiatives to meet the same.
Assist in the training and development of validation personnel.
Perform periodic SOP reviews 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 insights and quick resolution to observations or deviations.

Requirements
Education: Bachelor’s Degree in a related life sciences or Engineering field required. Equivalent professional work experience will be considered in lieu of a degree.
Experience:
Three (3) or more years of relevant validation experience required.
Minimum of two (2) years of validation experience specifically with sterile processes required.
Familiarity with Radiopharmaceutical processing is highly preferred.
Technical Skills: Working knowledge of global cGMPs (including EU standards), Validation Life Cycle, and pharmaceutical manufacturing requirements. Familiarity with sterile manufacturing/packaging facilities and operations.
Core Competencies: Results-oriented, able to make decisions and prioritize work per business needs in a fast-paced environment. Strong written and verbal communication, problem-solving, organization, and time management skills. Proficiency in Microsoft Office suite, statistical software, and Quality Documentation Management software.

Equal Opportunity Employer/Veterans/Disabled

Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State or local law; and Holiday pay upon meeting eligibility criteria. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs which are direct hire to a client

To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit https://www.entegee.com/candidate-privacy-information-statement/

The Company will consider qualified applicants with arrest and conviction records.
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