Perspective Therapeutics · 2 hours ago
Computer Systems Validation Engineer
Bloomington, IN
Full-time
Onsite
Senior Level
$100K/yr - $140K/yr
5+ years expPerspective Therapeutics is a start-up GMP-compliant Radioligand Therapy pharmaceutical manufacturing facility, seeking a Computer Systems Validation Engineer. The role involves executing software validation activities, ensuring compliance with regulatory requirements, and supporting the Engineering department as the site grows.
Health CareMedicalTherapeutics
Hiring Manager
Randy Gilbert
Responsibilities
Execute all computer system validation start-up activities, including production, quality, safety, and facility software to support GMP radiopharmaceutical manufacturing
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
Understand equipment and regulatory requirements to ensure the software properly supports their functions
Ensure compliance with cGMP, FDA, OSHA, and other regulatory requirements through effective management of validation, change controls, CAPA, and deviation activities
Develop and implement robust software validation programs
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
Work closely with vendors for procurement, installation, and validation of new software, ensuring alignment with site objectives and compliance standards
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
Author supporting documentation for qualification activities: URSs, FRSs, DSs, FAT/SAT Protocols, IQ/OQ/PQ Protocols, Traceability Matrices, related SOPs
Provides support for internal and FDA audits
Qualification
Required
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
Adherence to project timelines may require overtime work on evenings, weekends, and/or holidays
Ability to travel up to 10% domestically
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
Preferred
Direct experience with radiopharmaceutical or RLT facilities strongly preferred
Lean Six Sigma Green Belt or equivalent certification preferred
Knowledge of cGMP requirements preferred
Company
Perspective Therapeutics
Perspective Therapeutics focuses on advancing cancer treatments employing radiation, radiopharmaceuticals, and imaging technology.
51-200 employees
H1B Sponsorship
Perspective Therapeutics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
Funding
Current Stage
Public CompanyTotal Funding
$432.6MKey Investors
National Institutes of Health
2026-02-02Post Ipo Equity· $175M
2024-05-24Post Ipo Equity· $80M
2024-03-04Post Ipo Equity· $87.4M
Leadership Team
Thijs Spoor
Chief Executive Officer
Joel Sendek
Chief Financial Officer
Recent News
2026-02-02
2026-02-02
FiercePharma
2026-01-12
Company data provided by crunchbase