Computer System Validation (CSV) Engineer Job at Katalyst Healthcares and Life Sciences, Boston, MA

TjI4L1lEakx0cVh5eFd1QXFBY05QUjk3Mnc9PQ==
  • Katalyst Healthcares and Life Sciences
  • Boston, MA

Job Description

Responsibilities: Lead and execute CSV activities across GxP-regulated systems (LIMS, MES, ERP, etc. Author and maintain validation deliverables: URS, FS, DS, IQ, OQ, PQ, and traceability matrices. Ensure systems comply with 21 CFR Part 11, EU Annex 11, and GAMP 5. Support system implementations, upgrades, and periodic reviews. Collaborate with QA, IT, and business users to drive validation strategy. Participate in audits and inspections to demonstrate compliance. Requirements: Bachelor's degree in computer science, Engineering, Life Sciences, or related field. 2+ years of hands-on CSV experience in pharma, biotech, or medical device environments. Strong working knowledge of GxP, FDA regulations, and SDLC methodologies. Experience validating cloud-based or SaaS GxP systems is a plus. Excellent documentation, communication, and collaboration skills. Katalyst Healthcares and Life Sciences

Job Tags

Similar Jobs

Westfield State University

Security Patrol Officer (5326C), University Police - 75494 (San Francisco) Job at Westfield State University

 ...Security Patrol Officer (5326C), University Police - 75494 About Berkeley At the University of California, Berkeley, we are dedicated to fostering a community where everyone feels welcome and can thrive. Our culture of openness, freedom and belonging make it a special... 

Gateway Group Personnel

Paralegal Job at Gateway Group Personnel

 ...Job Description We have an East Memphis client who is searching for a Paralegal with estate planning and probate experience. Job Description: Assisting attorneys with trust and probate administration, including meeting with clients, trustees and family members... 

Performance Foodservice

Entry Level CDL Driver - Class B - Black River Produce Job at Performance Foodservice

 ...Growth opportunities performing essential work to support Americas food distribution system Safe and inclusive working environment,...  ..., and respect Position Purpose: Food and food service delivery Drivers fulfill a critical role in the countrys food supply chain... 

RecruitWell

CRNA - Anesthesiology job available in Muskegon, Michigan Job at RecruitWell

Job Description Muskegon, Michigan, CRNA Job Clinical Role: Do you know someone that might be a good fit for this position? Please ask about our generous referral fees! This state-of-the-art hospital is designated as a Level 2 trauma center and has 20 operating...

Detroit Medical Center

Registered Nurse (RN) - Director Perioperative Job at Detroit Medical Center

 ...Job Description Detroit Medical Center is seeking a Registered Nurse (RN) Director Perioperative for a nursing job in Hamtramck, Michigan. Job Description & Requirements ~ Specialty: Perioperative ~ Discipline: RN ~ Duration: Ongoing ~36 hours per week...