Engineer II, Computer Systems Validation

Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Job Description
Job Description
As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges.
About the Business
Join our Pharma Services Group (PSG)—a global leader providing integrated drug development and manufacturing solutions to pharmaceutical and biotech companies. Our Greenville, North Carolina site specializes in sterile and oral solid dose (OSD) manufacturing, supported by advanced technologies and a highly collaborative team environment.
Discover Impactful Work
As an Engineer II, Computer Systems Validation (CSV), you will support validation activities tied to automation systems, manufacturing equipment, and computerized systems across the site. This role is primarily focused on change management and validation of existing commercial manufacturing systems, ensuring compliance and operational readiness.
You will partner closely with automation, manufacturing, and quality teams to evaluate system changes, determine validation requirements, and execute qualification activities that maintain regulatory compliance and product quality.
A Day in the Life
Evaluate changes to existing manufacturing systems, equipment, and related databases
Support change management activities for commercial production lines
Author and execute validation documentation including IQ/OQ/PQ protocols and qualification plans
Perform risk assessments, validation assessments, and gap analyses to determine testing requirements
Collaborate with automation and engineering teams to qualify system changes
Support validation of automation and control systems (PLC, SCADA, DCS, DeltaV, etc.)
Ensure compliance with cGMP, FDA, and industry standards
Maintain accurate and compliant validation documentation
Participate in continuous improvement and operational excellence initiatives
Work Schedule & Environment
Standard schedule: Monday–Friday, 8:00 AM – 5:00 PM
Flexibility required to support off-hours work during shutdowns or system availability windows
Fully onsite role in Greenville, NC
Work may occur in manufacturing or controlled environments as needed
Keys to Success
Education (Required)
Bachelor’s degree in Engineering, Life Sciences, Chemistry, or related technical field
Equivalency:
Equivalent combinations of education, training, and relevant experience may be considered in place of a degree
Experience (Preferred, Not Required)
Approximately 2 years of experience in validation, CSV, or a GMP-regulated environment
Internship, co-op, or academic project experience in validation, automation, or regulated industries will also be considered
Knowledge, Skills, Abilities
Foundational understanding of cGMP and regulated environments
Exposure to Computer Systems Validation (CSV), CQV, or automation validation
Familiarity with automation/control systems (e.g., PLCs, SCADA, DCS, DeltaV, Allen-Bradley)
Ability to support development of validation protocols (IQ/OQ/PQ)
Strong technical writing and documentation skills
Basic understanding of risk assessments and gap analysis
Strong analytical and problem-solving skills
Effective communication and collaboration skills
Ability to manage multiple tasks in a fast-paced environment
Proficiency with Microsoft Office tools
Preferred Qualifications
Experience working with automation engineers or manufacturing systems
Exposure to change management processes in regulated environments
Familiarity with quality systems and validation lifecycle documentation
Competencies
Detail-oriented
Collaborative team player
Adaptable and flexible
Strong communicator
Quality and compliance focused
Additional Information
Role is primarily focused on Computer Systems Validation (CSV), with potential exposure to capital projects as business needs evolve
This position is not expected to independently lead full-scale capital validation projects at this level
Designed to support growth and development with guidance from experienced team members