Computer Systems Validation Engineer (New Hampshire) Job at SoTalent, New Hampshire

VTZZL1NiL0hSNjJneG1LRXZmMDZLaXlQcVE9PQ==
  • 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. Youll 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 Youll Bring

  • Bachelors 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, Part time, Relocation,

Similar Jobs

Good Samaritan

Nursing Home Administrator - Long Term Care Job at Good Samaritan

 ...provides equipment and supplies to support QAPI efforts. The Administrator is the Compliance Liaison of the facility, with a...  ...required. The ability to be a licensed as a Nursing Home Administrator in the state of practice is required.... 

Kanshe Infotech

SAP FICO - Business Analyst Job at Kanshe Infotech

 ...Job Title: SAP FICO Business Analyst Work Location: Franklin Lakes (Remote) Note: If the candidate resides within 100 km of Parsippany, Troy Hills, or nearby NJ locations , occasional onsite travel is expected. Job Overview We are seeking an experienced... 

Therapy Matters, Inc.

Music Therapist Job at Therapy Matters, Inc.

 ...Job Description Music Therapist Therapy Matters Location: Chandler, AZ (Onsite Role) Compensation: $30$35/hour based on experience and certification status Schedule: Part-Time or PRN (Sessions available Monday-Friday, 8 AM - 7 PM) About Therapy Matters... 

Mosaic Life Care

Certified Nursing Assistant / Patient Care Associate Job at Mosaic Life Care

 ...Details Certified Nursing Assistant / Patient Care Associate Medical Center Full Time / Part Time / PRN Status Day/ Night Pay: $16.97 - $22.07 / hour Summary This position works under the direction of an RN/LPN or Provider and administers... 

Strategic Workforce Development Inc.

FedEx Package Handler Job at Strategic Workforce Development Inc.

Come for a job and stay for a career! FedEx Ground is part of the rapidly growing warehouse and transportation sector that helps keep America,...  ...loading, unloading, and sorting of packages of various sizes.Part time employees work one shift a day; full time employees work two...