Computer System Validation Manager Jobs in Boca Raton, FL

The Quality Control (QC) Instrumentation and Validation Supervisor is responsible for managing the lifecycle, qualification, maintenance, and compliance support of QC laboratory equipment, instrumentation, and computerized systems. This position provides technical leadership for equipment validation, computer system validation (CSV), laboratory improvements, and regulatory compliance initiatives.

The role ensures that QC laboratory systems remain qualified, reliable, and compliant with applicable GMP, FDA, and industry standards. The position collaborates cross-functionally with Quality Assurance, QC, Manufacturing, Engineering, Regulatory, and other departments to support business objectives while minimizing operational impact.

Salary: 85k a year

• Provide technical validation support for QC laboratory equipment, instrumentation upgrades, replacements, and modifications.
• Develop, execute, review, and approve validation and qualification documentation, including:
• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Performance Qualification (PQ)
• Computer System Validation (CSV) documentation
• Prepare validation protocols, reports, risk assessments, and supporting documentation.
• Perform and oversee field activities, including project coordination, audits, sampling activities, testing requests, protocol execution, and data collection.
• Support computerized laboratory systems, including data acquisition systems, chromatographic data systems, and laboratory information management systems.

• Manage QC instrumentation lifecycle activities, including installation, qualification, calibration, maintenance, troubleshooting, and retirement.
• Coordinate and document equipment troubleshooting, corrective actions, and preventive maintenance activities.
• Support equipment selection, laboratory system improvements, and technology evaluations.
• Identify opportunities for continuous improvement of QC laboratory processes and systems.

• Support QA, Manufacturing, and Compounding validation activities as required.
• Develop, issue, and execute validation protocols, summary reports, and associated documentation.
• Review validation data, perform data analysis, summarize results, and prepare validation conclusions.
• Develop remediation plans and support implementation of corrective actions when required.
• Assist with the development and maintenance of Master Validation Plans.
• Provide backup support to Validation Engineers and Validation leadership.

• Support laboratory compliance with FDA regulations, GMP requirements, and applicable industry standards.
• Participate in internal and external audits and regulatory inspections.
• Author, review, and approve quality documents, including:
• Standard Operating Procedures (SOPs)
• Change Controls
• Deviations
• Investigations
• Risk Assessments
• Corrective and Preventive Actions (CAPA)
• Maintain current knowledge of regulatory expectations and industry best practices.

• Promote safe laboratory practices and compliance with applicable safety requirements.
• Provide coaching, technical guidance, and training related to QC equipment and instrumentation.
• Collaborate effectively with cross-functional teams to achieve department and company objectives.
• Demonstrate leadership through effective communication, problem-solving, and team development.

• Bachelor’s degree in Chemistry, Pharmaceutical Sciences, Biology, Engineering, or a related scientific discipline.
• Minimum of 10 years of relevant hands-on experience in analytical laboratory environments, pharmaceutical manufacturing, or regulated industries; equivalent combinations of education and experience may be considered.
• Strong background in analytical chemistry, including:
• Wet chemistry
• Chromatography
• Spectroscopy
• Pharmaceutical instrumental analysis
• Extensive experience with laboratory instrumentation, troubleshooting, and qualification activities, including:
• HPLC
• GC
• FTIR
• Other analytical laboratory systems
• Experience with equipment validation, method validation, method transfer, and commercial manufacturing support.
• Knowledge of computerized system lifecycle principles and software quality assurance practices in regulated environments.
• Working knowledge of GMP requirements, including 21 CFR Parts 210 and 211.
• Familiarity with FDA expectations, ICH guidelines, and applicable compounding regulations is preferred.

• Strong technical understanding of analytical instrumentation and laboratory systems.
• Ability to troubleshoot complex scientific and technical problems.
• Strong critical thinking and decision-making abilities.
• Excellent organizational skills with the ability to manage multiple priorities.
• Ability to work independently with minimal supervision.
• Strong written and verbal communication skills.
• Ability to collaborate effectively across departments and organizational levels.
• Strong coaching, mentoring, and leadership abilities.
• Ability to influence decisions, negotiate solutions, and manage competing priorities.
• Demonstrated ability to work successfully in a fast-paced, regulated environment.

Working knowledge of Microsoft Office Suite, including Excel, Word, and PowerPoint. Experience with laboratory and quality systems software is preferred, including:

• OpenLab
• MicroLab
• SphereFlash
• Soleris
• QBench
• MasterControl
• ElementalMachines
• Other laboratory data management or computerized quality systems

• Ability and willingness to travel periodically for business purposes.
• Flexibility to work extended hours when required to support business needs.
• Ability to sit or stand for extended periods, including up to eight hours per day.
• Ability to wear required personal protective equipment (PPE), including respiratory and hearing protection, when entering regulated facility areas.
• Correctable vision to 20/40 or better.
• Ability to lift and carry up to 25 pounds.

• Experience supporting regulatory inspections and agency interactions.
• Experience leading validation projects in pharmaceutical, biotechnology, or regulated manufacturing environments.
• Demonstrated success managing cross-functional technical projects.
• Experience implementing laboratory improvements and continuous improvement initiatives.