Computer Systems Validation Engineer Job at SoTalent, New Hampshire

QklxVnFHeE9CRENKUmY0aER4VFd6RTcyOUE9PQ==
  • SoTalent
  • New Hampshire

Job Description

Computer Systems Validation (CSV) Engineer

📍 Portsmouth, NH (On-site, full-time)

We are seeking a Computer Systems Validation Engineer to support operations within a GMP-regulated environment. This role focuses on implementing industry best practices within GAMP frameworks, ensuring compliance with regulatory requirements, and maintaining validation integrity across critical systems. You’ll also provide guidance to junior team members and act as a subject matter expert during audits and inspections.

Key Responsibilities

  • Lead validation activities, ensuring effective communication, prioritization, and timely delivery.
  • Maintain expertise in 21 CFR Part 11, Data Integrity, ICH Q7A, GAMP , and related regulations.
  • Execute Quality Systems processes: Change Control, Deviations, CAPAs, and Validation Maintenance .
  • Draft and review protocols, risk assessments, test scripts, and GMP documentation.
  • Own and maintain CSV SOPs and departmental procedures.
  • Act as SME during audits and inspections.
  • Mentor and train junior validation team members.

What You’ll Bring

  • Bachelor’s degree in Computer Science, Engineering, or related discipline.
  • 4+ years experience in automation and/or computerized system validation.
  • 2+ years hands-on experience with PLCs, Controls Automation, SCADA, DCS, BAS/BMS, or MES (DeltaV preferred).
  • Prior experience leading/managing validation projects is a plus.
  • Strong knowledge of CAPAs and deviations.
  • Background in biotech, pharma, medical device, or biologics required.
  • Detail-oriented, independent, and deadline-driven.

💡 This is a 100% on-site role in Portsmouth, NH . Relocation within commuting range is required.

Job Tags

Full time, Relocation,

Similar Jobs

Arevna

Commercial Real Estate Associate (Attorney) Job at Arevna

 ..., diversity of thought, and sustained community impact. THE OPPORTUNITY The Charleston office is seeking a Mid-Level Real Estate Associate to strengthen its high-performing real estate practice. This individual will operate as a strategic advisor across a broad... 

U.S. Engineering

Manufacturing Engineer I Job at U.S. Engineering

 ...Manufacturing Engineer I Metalworks Manufacturing Engineer I organizes the work being performed through an in-house technology platform. This includes data collection and communication with a variety of sources and data input, plus estimating. The ME also plays a key... 

Veloci Running

Integrated Marketing Manager Job at Veloci Running

 ...consistent brand voice, as well as campaigns across earned media, influencer partnerships, digital channels, email, retail activations, and events. Own community and partnership management : build partnerships and manage relationships with run clubs, field reps, athletes, &... 

Taylor Bros. Construction Co., Inc.

Retail Fixture Traveling Superintendent Job at Taylor Bros. Construction Co., Inc.

 ...efficiently. Primary Role: Physically assembles and installs retail fixtures (shelving, gondolas, display cases, cabinetry) according to store layouts and construction plans. Focus: Structural setup and alignment for safety, durability, and compliance with building codes... 

San Lorenzo Int'l, Inc.

Order Fulfillment Associate Job at San Lorenzo Int'l, Inc.

 ...Time | Pay based on experience Were a growing company seeking a reliable, detail-oriented individual to join our team as an Order Fulfillment Associate. This position involves processing and packing customer orders from platforms such as Amazon, Etsy, and our own e-...