Validation Engineer

Validation Engineer (CQV and CSV)

Location: Southwest Florida, onsite

Type: Full-time, direct hire

About the opportunity

A growing, clinical-stage oncology company is building its GMP capabilities and is hiring a hands-on Validation Engineer. You'll shape the validation program from the ground up: writing the Validation Master Plan, setting the strategy, and qualifying the systems, equipment, utilities and facilities that will support new cancer therapies.

This is not a role where you run one piece of a large validation department. You'll own both equipment qualification and computer system validation, work directly with Quality leadership, and see your work go all the way from the requirements document to the final report.

What you'll do

• Plan, write and execute commissioning, qualification and validation for lab equipment, manufacturing equipment, utilities and facilities, following ISPE C&Q (2nd Edition) and FDA expectations
• Write and maintain the Validation Master Plan, project validation plans, SOPs and process flow diagrams
• Lead system impact assessments and equipment classification, using a risk-based approach
• Write and execute the full qualification document set: URS/SRS, design reviews, DQ, IQ, OQ, PQ, traceability matrices and summary reports, making good use of vendor documentation
• Own computer system validation for GxP systems (GAMP 5 Category 4 and 5): validation plans, requirements, functional and configuration specs, risk assessments, test scripts, traceability matrices, summary reports and periodic reviews
• Assess systems against 21 CFR Part 11 and data integrity (ALCOA+) requirements, including access controls, audit trails, electronic signatures, backup and recovery, and record retention
• Support cleaning validation, process validation and temperature mapping
• Manage deviations, change control assessments and requalification to keep systems in a validated state
• Work with QA, IT, Engineering, Manufacturing, the lab and Facilities to define requirements and acceptance criteria

What you bring

• Bachelor's degree in engineering, computer science, life sciences or a related field
• 5+ years of equipment qualification and validation in pharma, biotech or medical devices
• 3+ years of hands-on computer system validation, including GAMP 5 Category 4 and 5 systems
• Experience across several of these areas: lab systems and equipment, manufacturing equipment, utilities, cleaning validation, process validation, temperature mapping
• Strong knowledge of GAMP 5, the ISPE C&Q lifecycle, 21 CFR Part 11 and data integrity principles
• Excellent technical writing, with a track record of producing audit-ready documentation
• Able to work independently, manage several projects at once and solve complex equipment deviations

Nice to have

• Experience starting up a new facility or building a validation program from scratch
• Experience with radiopharmaceuticals, aseptic processing, isolators or hot cells [confirm with client]
• Validation consulting background with exposure to several sites

Why this role

• Build the validation program yourself instead of maintaining someone else's
• High visibility and direct access to leadership at a company with a growing clinical pipeline
• Work on therapies aimed at hard-to-treat cancers

To apply or learn more, send your resume to [email protected] . All inquiries are handled confidentially.