Engineer III, Computer Systems Validation

Work Schedule

Environmental Conditions

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.

Description:

Join our validation engineering team as aValidation Engineer III (Computer Systems Validation – CSV), where you will ensure product quality and regulatory compliance across pharmaceutical manufacturing operations.

In this role, you will lead and execute validation activities with a strong focus onautomation systems, computerized systems, and change management for existing commercial manufacturing lines. You will evaluate system and process changes, determine validation impact, and drive qualification strategies to ensure compliance with cGMP requirements.

You will collaborate cross-functionally with automation, manufacturing, and quality teams while serving as a technical resource during regulatory inspections and client audits. This role requires a high level of independence, technical expertise, and the ability to lead complex validation efforts.

A Day in the Role:

• Lead validation activities forequipment, processes, utilities, and computer systems, with emphasis on CSV

• Evaluate and supportchange management for existing manufacturing systems and automation platforms

• Author, review, and execute validation documentation includingIQ/OQ/PQ protocols and qualification plans

• Perform and leadrisk assessments, gap analyses, and validation assessments

• Collaborate with automation engineers on systems such asPLC, SCADA, DCS, DeltaV, and Allen-Bradley platforms

• Independently manage validation projects and coordinate cross-functional teams

• Provide technical expertise duringregulatory inspections and client audits

• Mentor junior team members and support knowledge sharing across the team

• Contribute tocontinuous improvement and operational excellence initiatives

Requirements:

• 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

• Minimum of4 years of validation experience in pharmaceutical/biotech manufacturing or comparable regulated industry

• Strong knowledge ofcGMP regulations (FDA, EMA, ISO)

• Experience withComputer Systems Validation (CSV), CQV, or automation validation

• Experience writing and executingIQ/OQ/PQ validation protocols

• Experience withautomation and control systems (PLC, SCADA, DCS, DeltaV, Allen-Bradley)

• Proven ability tolead validation projects and work cross-functionally

• Strong technical writing and documentation skills

• Experience withrisk assessment methodologies and statistical analysis

• Advanced problem-solving and root cause analysis skills

• Excellent verbal and written communication skills

• Proficiency with MS Office and validation-related systems

Preferred:

• Experience supporting or contributing tocapital (CapEx) projects

• Experience withregulatory inspections and client audits

• Knowledge oflean manufacturing and continuous improvement methodologies

Additional Information:

• Ability to work in cleanroom environments as required

• Flexibility to support extended hours or off-shift work during project activities or shutdowns

• May require up to 25% travel