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