Engineer II, Computer Systems Validation

JOB DESCRIPTION

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