Engineer II, Computer Systems Validation

Thermo Fisher

Greenville, NC

JOB DETAILS
SKILLS
Allen-Bradley, Analysis Skills, Automation, Automation Engineering, Automation Systems, Biology, Biotech and Pharmaceutical, Capital Project, Change Management, Chemistry, Communication Skills, Computer Systems, Continuous Improvement, Control Systems, Current Good Manufacturing Practice (cGMP), DeltaV, Detail Oriented, Distributed Control Systems (DCS), Drug Development, Drug Manufacturing, FDA (Food and Drug Administration), GMP (Good Manufacturing Practices), Gap Analysis, Industry Standards, Maintain Compliance, Manufacturing, Manufacturing Analysis, Manufacturing Automation, Manufacturing Equipment, Manufacturing Systems, Microsoft Office, Multitasking, Operational Improvement, Problem Solving Skills, Process Validation, Programmable Logic Controller (PLC), Requirements Validation/Verification, Risk Analysis, Supervisory Control and Data Acquisition (SCADA), System Lifecycle, System Validation, Systems Engineering, Team Player, Technical Writing, Test Requirements, Validation Documentation, Validation Plan, Writing Skills
LOCATION
Greenville, NC
POSTED
3 days ago
Engineer II, Computer Systems Validation (CSV)

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.

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.

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

About the Company

T

Thermo Fisher

Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science. Our mission is to enable our customers to make the world healthier, cleaner and safer. With revenues of nearly $11 billion, we have approximately 37,000 employees and serve customers within pharmaceutical and biotech companies, hospitals and clinical diagnostic labs, universities, research institutions and government agencies, as well as in environmental and process control industries. We create value for our key stakeholders through two premier brands, Thermo Scientific and Fisher Scientific, which offer a unique combination of continuous technology development and the most convenient purchasing options. Our products and services help accelerate the pace of scientific discovery, and solve analytical challenges ranging from complex research to routine testing to field applications.

All of our employees share a common set of values - Integrity, Intensity, Innovation and Involvement. Our ability to grow year after year is driven by our ability to attract, develop and retain world-class people who will thrive in our environment and share in our desire to improve mankind by enabling our customers to make the world healthier, cleaner and safer.

If you share in our values and if you're looking for an employer who is strongly committed to developing talent and rewarding achievement, come grow with us at Thermo Fisher Scientific.

Thermo Fisher Scientific is an Equal Employment Opportunity and Affirmative Action employer.

COMPANY SIZE
10,000 employees or more
INDUSTRY
All
WEBSITE
https://corporate.thermofisher.com/en/home.html