Computer Systems Validation Engineer

Objective

As the Computer System Validation (CSV) Engineer for Perspective Therapeutics in Bloomingdale, IL, you will be executing all software validation activities for a brand-new start-up GMP-compliant Radioligand Therapy (RLT) pharmaceutical manufacturing facility. You will be responsible for ensuring that all software is designed, installed, tested, and maintained in good compliance with global regulatory requirements (cGMP, FDA, ISO, EU, etc.). You will follow the established CQV (Commissioning, Qualification, Validation) strategy for all systems to be used at the site, author governing documents (such as software specific SOPs), manage vendors and internal stakeholders, and ensure successful transition from project execution to GMP operations.

The CSV Engineer will amass all software SME knowledge; they will support the Engineering department as the site grows and matures. Also, this position will be a key role in providing support for internal and FDA audits.

Essential Functions

• Facility Start-Up: Execute all computer system validation start-up activities, including production, quality, safety, and facility software to support GMP radiopharmaceutical manufacturing. Establish software specific standard operating procedures, and workflows required to transition from start-up to steady-state manufacturing. Support initial regulatory inspections and audits associated with facility start-up and first product launches.
• CQV Strategy: Work with Project Managers and stakeholders to define and align qualification strategies with equipment lead times to ensure continuous CSV activities are being executed while adhering to aggressive timelines.
• Maintenance & Calibration: Understand equipment and regulatory requirements to ensure the software properly supports their functions. Provide subject matter expertise for production and facilities software (CMMS, EMS/BMS, etc.).
• Compliance & Validation: Ensure compliance with cGMP, FDA, OSHA, and other regulatory requirements through effective management of validation, change controls, CAPA, and deviation activities. Aid the site through regulatory inspections with zero observations. Author and execute Change Controls through the Quality Management System. Create and revise SOP documentation governing operation and facility practices.
• Qualification Improvements: Develop and implement robust software validation programs. Drive continuous improvement initiatives using lean manufacturing and Six Sigma methodologies to optimize efficiency.
• Cross-Functional Collaboration: Collaborate with key internal stakeholders such as Production, Quality, Environment Health & Safety, to support site operations in resolving engineering challenges, and ensuring timely project execution.
• Vendor Management: Work closely with vendors for procurement, installation, and validation of new software, ensuring alignment with site objectives and compliance standards. Trainer and access management of third-party contractors and vendors.
• Equipment & Systems: Familiarize yourself with the following types of software: Product Synthesizers, Lead-Shielded Isolators, Dispensing Systems, Dose Calibrators, Visual Inspection machines, Particle Counters & Air Samplers, BSCs & Fume Hoods, CMMS (BMRAM), BMS, EMS, Production software, Access Controls, etc.
• Documentation: Author supporting documentation for qualification activities: URSs, FRSs, DSs, FAT/SAT Protocols, IQ/OQ/PQ Protocols, Traceability Matrices, related SOPs
• Other: Provides support for internal and FDA audits.

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education/Experience

• Bachelor's degree (required) in Chemical, Mechanical, Industrial Engineering, or related field
• Minimum of 5 years of experience in an engineering role within the pharmaceutical or life sciences industry
• Direct experience with radiopharmaceutical or RLT facilities strongly preferred
• Proven expertise in computer system validation, and compliance with FDA and GMP standards
• Experience with project management, including design, and validation of manufacturing and packaging lines
• Strong knowledge of BMRAM, EMS, BMS, Salesforce, and other relevant engineering management systems
• Lean Six Sigma Green Belt or equivalent certification preferred.
• Experience with MS Office Suite required

Knowledge / Skill / Ability

• Strong interpersonal skills and the ability to communicate effectively verbally and via email
• Understanding of project accounting, project planning, execution and startup
• Experience with equipment to support GMP and non-GMP operations, packaging equipment and engineering system controls (e.g. HVAC systems, utility systems)
• Familiarity with Computerized Maintenance Management Systems
• Knowledge of safety procedures for working in a hazardous environment (chemical or radiological) as demonstrated through prior experience
• Knowledge of cGMP requirements preferred
• Adherence to project timelines may require overtime work on evenings, weekends, and/or holidays.
• Ability to travel up to 10% domestically.

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Must be willing to work in a facility producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels
• Mechanical aptitude required; manual dexterity for manipulating small items; ability to lift up to 50 lbs. and to handle frequent crawling, stooping, crouching, and kneeling
• Must be willing to wear a variety of personal protective equipment
• May be required to sit or stand for long periods of 8+ hours a day while performing duties
• Willingness to complete safety training within allotted timeframes, and work in a team-based environment

Perspective Therapeutics provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

For information on Perspective Therapeutics, visit our website at: www.perspectivetherapeutics.com.