Computer Validation Specialist - Level 2

Computer Validation Specialist - Level 2 at SoTalent Computer Validation Specialist - Level 2 at SoTalent in Rye, New Hampshire Posted in 1 day ago.

Type:

full-time

Job Description:

Job Title:

Computer Systems Validation Specialist (Level 2)

Location:

Portsmouth, New Hampshire, United States Industry:

Pharmaceuticals / Biotechnology / Life Sciences (GMP Manufacturing)

Function:

Quality Assurance / Computer Systems Validation (CSV) /

Automation & Engineering Employment Type:

Full-time About the Role We 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 Do Lead and execute CSV activities for new and changing computer systems Perform risk assessments and evaluate system impact and compliance requirements Review change controls, validation protocols, and test scripts Draft, review, and maintain GMP validation documentation Support validation lifecycle activities for computerized systems (maintenance, updates, requalification) Oversee CSV execution for systems such as DeltaV and Syncade Review engineering and technical documentation (P&IDs, specifications, SOPs, submittals) Participate in audits and regulatory inspections as CSV SME Support and execute QA processes including CAPAs, deviations, and change controls Contribute to SOP development and updates for CSV processes Act as CSV project lead for smaller or defined scope projects Provide mentorship and guidance to junior CSV team members What We're Looking For Bachelor's degree in Computer Science, Engineering, or related technical field 0-4 years of experience in Computer Systems Validation (CSV) Experience in biotech, pharmaceutical, or medical device manufacturing environments Hands-on experience with automation and control systems such as: PLCs

SCADA DCS

(Distributed Control Systems) MES (Manufacturing Execution Systems)

BAS / BMS

systems DeltaV (preferred) Experience with GMP quality systems including deviations, CAPAs, and change control Strong attention to detail and ability to manage multiple priorities and deadlines Ability to work independently in an onsite GMP environment Nice to Have Experience supporting validation in regulated manufacturing systems Exposure to large-scale automation or process control environments Prior involvement in audits or regulatory inspections Experience working in cross-functional engineering and QA teams Compensation & Benefits Competitive salary (based on experience and qualifications) Comprehensive benefits package (medical, dental, vision, retirement) Career development and training opportunities Exposure to advanced life sciences manufacturing technologies Supportive and collaborative team environment Work Environment Onsite role in a GMP manufacturing facility in Portsmouth, NH Cross-functional collaboration with QA, Engineering, Automation, and Manufacturing teams High-visibility role supporting validated systems critical to production Why Apply This 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.