Computer Systems Validation Engineer

Perspective Therapeutics•Chicago, IL

10h•Onsite

About The Position

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.

Requirements

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
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
Experience with MS Office Suite required
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.

Nice To Haves

Direct experience with radiopharmaceutical or RLT facilities strongly preferred
Lean Six Sigma Green Belt or equivalent certification preferred.

Responsibilities

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.