Job Description & Details
This is a specialized consulting gig focused entirely on compliance and validation within the pharmaceutical space, specifically dealing with chromatography data systems. If you know your way around computer software assurance and data integrity frameworks, this is a straightforward contract that lets you lean heavily on your regulated industry background without getting bogged down in endless greenfield development.
What You'll Actually Be Doing
Your day-to-day will revolve around ensuring that complex lab systems, specifically Empower or equivalent HPLC software, are fully compliant and ready for inspection. You'll spend a lot of time writing validation documentation, orchestrating test strategies using risk-based CSA methodologies, and wrestling with Quality Management System processes like handling deviations, CAPA resolution, and managing change controls when system configurations inevitably shift.
The Core Tech Stack
You need absolute fluency in Computer Software Assurance (CSA) and Computer Systems Validation (CSV) principles applied specifically to life sciences. Experience with Empower or similar HPLC chromatography data software is non-negotiable here, alongside a deep, practical understanding of GxP, 21 CFR Part 11, EU Annex 11, and ALCOA+ data integrity rules. The team is relying on your familiarity with ISPE guidelines to streamline testing without cutting corners on regulatory scrutiny.
Interview Expectations
Expect the hiring manager to ask you to walk through a scenario where an unexpected deviation occurred during the validation of a chromatography data system, and how you handled the resulting CAPA and change control. They aren't looking for textbook definitions; they want to hear how you balance rigorous compliance with realistic project timelines under audit pressure. They will likely also test your grasp of risk-based CSA testing versus traditional heavy-documentation CSV to see if you can actually save time while maintaining quality.
Application Advice
When you submit your resume via email, make sure your formatting explicitly calls out your hands-on experience with Empower and specific regulatory frameworks like 21 CFR Part 11 and ALCOA+. Don't just list them as keywords; write bullet points that demonstrate how you managed validation documentation and QMS processes in past pharma gigs. Since the application relies on an email drop, clearly layout your current location, visa status, availability, and expected hourly rate right in your cover note to avoid unnecessary back-and-forth.