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

R2o1anMxeExTV3pkN2dBL3A3bWQzMld4YUE9PQ==
  • 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

Tenet-AZ Region

Pharmacist Job at Tenet-AZ Region

 ...Rotating Shifts)\n Location: Abrazo Arrowhead Campus, 67th Ave & W Union Hills Dr, Glendale, AZ \n About the Role \n We are seeking...  ...and dispense medications in compliance with federal, state, and local laws, including controlled substance regulations. \n... 

Technology Security Associates, Inc.

Program Protection Security Analyst Job at Technology Security Associates, Inc.

 ...Job Description Job Description Program Protection Security Analyst Technology Security Associates (TSA) is seeking a Program Protection Security Analyst (Journeyman level) to support our government customer at NAS Patuxent River, MD. This is a fully onsite position... 

FedEx

Seasonal Package Handler - Part Time (Warehouse like) Job at FedEx

 ...IMMEDIATE OPENINGS! Come for a job and stay for a career! Federal Express Corporation (FEC) is part of the rapidly growing warehouse and transportation sector that helps keep America, and our economy, moving. Be part of a winning team and workplace community that cares... 

CyberCoders

Site Safety and Health Officer Job at CyberCoders

 ...Site Safety and Health Officer (SSHO) Position Overview We are seeking a dedicated Site Safety and Health Officer (SSHO) to ensure compliance with safety regulations and standards on our civil construction projects. The SSHO will play a critical role in promoting... 

Crisp Regional

Certified Nursing Assistant - Crisp Agency Job at Crisp Regional

 ...Position Summary: Up to 16-week Contract Under the leadership of the departmental Nursing Director and the supervision of a licensed nurse, the Agency Certified Nursing Assistant provides culturally sensitive, developmentally appropriate patient care. The Agency...