Computer Systems Validation Engineer Job at BW Design Group, Boston, MA

cHFCTnZrYXZWMytYQTJBVzlPZlM0b0RnZ0E9PQ==
  • BW Design Group
  • Boston, MA

Job Description

Join to apply for the Computer Systems Validation Engineer role at BW Design Group When you join Design Group as a Computer Systems Validation Engineer, you become part of a team that challenges you and supports your growth. In this role, you will collaborate with industry experts to help leading companies solve complex problems. You will join our Regulatory Compliance Practice, working alongside seasoned leaders, technical specialists, and subject matter experts to deliver high-quality, consistent solutions to our clients. What You’ll Do Interface with clients and take responsibility for preparing and executing computer system validation documents for various control and production systems. Develop and execute validation test scripts, including SFATs, HFATs, traceability matrices, IQs, and OQs. Participate in good documentation practices (cGMP and FDA CQV). Read engineering documents, prioritize tasks, and manage multiple projects simultaneously. Communicate effectively both verbally and in writing. Make a daily impact with your skills, strengthening relationships with clients and team members. What You’ll Bring At least four years of validation experience in regulated industries such as pharmaceutical, biotech, or medical devices. Knowledge of FDA Data Integrity requirements, risk assessments, and gap analyses. Understanding of GAMP and 21 CFR Part 11. Experience with software lifecycle documentation like FRSs, SDSs, HDSs, and configuration specs. Hands-on experience with platforms like Emerson DeltaV, Syncade, Allen Bradley PLC, Wonderware, OSI PI, or Rockwell. Knowledge of laboratory systems and CSV for process control in clean utilities and bioprocessing. Understanding of biologic operations, including fermentation and purification. Willingness to travel for project needs, including installation, startup, and industry events. Bachelor’s degree in engineering, computer science, or related field. Our culture emphasizes mutual respect, integrity, and individual growth. We support your professional development through mentorship, development plans, and career resources. Join us to build a rewarding career surrounded by talented professionals who will support your growth as both an engineer and leader. #J-18808-Ljbffr BW Design Group

Job Tags

Similar Jobs

NurseRecruiter

ADVANCED PRACTICE PROVIDER (NP & PA) - NOW 10K Sign On!!! Job at NurseRecruiter

ADVANCED PRACTICE PROVIDER (NP & PA) - NOW 10K Sign On!!!Are you looking for a career you can feel good about? We hire only those that...  ...a variety of views, perspectives, and backgrounds are integral parts of our company's success.We believe that work is more than a... 

Trillium Staffing

Apprentice Electrician Job at Trillium Staffing

 ...Job Description Job Description Apply Apprentice Electrician Kaufman, Texas - Posted on June 20, 2025 Published By Olivia Barnes Trillium Construction is now seeking Apprentice Electricians in Kaufman, TX! Pay rate is up to $31 per hour depending on... 

OneSparQ

Radio Field Technician (JOB ID 1428) Job at OneSparQ

 ...Additional Skills: (not required) Experience with camera systems such as Avigilon, Pelco, or comparable brands Background in low-voltage systems, electronics training, soldering, and interpreting electronic schematics Hands-on experience with car audio wiring... 

Kelly Services Inc.

12952 - Kelly Education Recruiting and Onboarding Manager - Orlando, FL Job at Kelly Services Inc.

Together we change lives.Kelly is a team of experts driven by our belief that the impact of the right person in the right job is limitless...  ...Collaborating closely with recruiters, clients, and client services teams to understand talent needs and proactively address... 

Meals Now

Catering Delivery Driver in Wichita, Kansas Job at Meals Now

 ...individuals who excel in customer service and are eager to manage catered food deliveries from a diverse range of restaurants within your...  ...representing our brand. To qualify, you must possess a valid driver's license, have current insurance, reliable transportation, a...