Job Description & Details
This is a hands-on, highly regulatory-focused contract role for someone who knows pharma compliance inside and out. You will be stepping into a hybrid setup requiring three days a week on-site in Rahway to keep critical systems compliant with strict FDA mandates.
What You'll Actually Be Doing
You will spend your days driving Computer System Validation and Computer Software Assurance for major capital and strategic projects. Expect to spend a lot of time authoring, reviewing, and approving validation lifecycle documents while partnering with cross-functional teams to manage change controls and risk assessments. You'll act as the technical unit approving SDLC deliverables and keeping compliance metrics tight across shopfloor, enterprise, and lab systems.
The Core Tech Stack
You need deep, practical fluency in GAMP 5, FDA 21 CFR Part 11, and EU GMP Annex 11. Success here relies on your ability to apply risk-based validation and CSA principles rather than blindly following heavy paperwork, alongside solid execution of the Software Development Lifecycle and change management processes within GMP environments.
Interview Expectations
The hiring manager is going to probe how you handle real-world deviations during a tight project timeline, looking to see if you can balance compliance rigidity with practical risk management. They will also likely present a scenario involving a legacy system update to test your grasp on applying GAMP 5 and CSA principles without breaking regulatory protocols.
Application Advice
Make sure your resume explicitly highlights your hands-on work with 21 CFR Part 11, GAMP 5, and CSA methodologies within pharma or biotech settings. Drop specific keywords like 'SDLC', 'change control', 'deviation processes', and 'capital projects' right into your experience bullets so you easily clear the ATS filter.