Computer Validation Specialist - Level 2

Job Title: Computer Systems Validation Specialist (Level 2)Location: Portsmouth, New Hampshire, United StatesIndustry: Pharmaceuticals / Biotechnology / Life Sciences (GMP Manufacturing)Function: Quality Assurance / Computer Systems Validation (CSV) / Automation & EngineeringEmployment Type: Full-timeAbout the RoleWe are seeking a Computer Systems Validation (CSV) Specialist to support the validation, compliance, and lifecycle management of computerized systems within a regulated GMP manufacturing environment. This role is responsible for ensuring that computer systems used in manufacturing and quality operations remain compliant with internal policies, regulatory expectations, and industry standards.You will act as a key CSV representative across projects, supporting validation activities, documentation, testing, and quality system processes while also providing guidance to junior team members.What You'll DoLead and execute CSV activities for new and changing computer systemsPerform risk assessments and evaluate system impact and compliance requirementsReview change controls, validation protocols, and test scriptsDraft, review, and maintain GMP validation documentationSupport validation lifecycle activities for computerized systems (maintenance, updates, requalification)Oversee CSV execution for systems such as DeltaV and SyncadeReview engineering and technical documentation (P&IDs, specifications, SOPs, submittals)Participate in audits and regulatory inspections as CSV SMESupport and execute QA processes including CAPAs, deviations, and change controlsContribute to SOP development and updates for CSV processesAct as CSV project lead for smaller or defined scope projectsProvide mentorship and guidance to junior CSV team membersWhat We're Looking ForBachelor's degree in Computer Science, Engineering, or related technical field0–4 years of experience in Computer Systems Validation (CSV)Experience in biotech, pharmaceutical, or medical device manufacturing environmentsHands-on experience with automation and control systems such as:PLCsSCADADCS (Distributed Control Systems)MES (Manufacturing Execution Systems)BAS / BMS systemsDeltaV (preferred)Experience with GMP quality systems including deviations, CAPAs, and change controlStrong attention to detail and ability to manage multiple priorities and deadlinesAbility to work independently in an onsite GMP environmentNice to HaveExperience supporting validation in regulated manufacturing systemsExposure to large-scale automation or process control environmentsPrior involvement in audits or regulatory inspectionsExperience working in cross-functional engineering and QA teamsCompensation & BenefitsCompetitive salary (based on experience and qualifications)Comprehensive benefits package (medical, dental, vision, retirement)Career development and training opportunitiesExposure to advanced life sciences manufacturing technologiesSupportive and collaborative team environmentWork EnvironmentOnsite role in a GMP manufacturing facility in Portsmouth, NHCross-functional collaboration with QA, Engineering, Automation, and Manufacturing teamsHigh-visibility role supporting validated systems critical to productionWhy ApplyThis role is ideal for someone looking to build or grow a career in Computer Systems Validation within a global life sciences environment. You'll gain exposure to advanced manufacturing systems, regulatory frameworks, and end-to-end validation processes that directly support the production of life-changing therapies.