R-01346131 Engineer III, Computer Systems Validation

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office

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 a Validation 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 on automation 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 for equipment, processes, utilities, and computer systems, with emphasis on CSV

• Evaluate and support change management for existing manufacturing systems and automation platforms

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

• Perform and lead risk assessments, gap analyses, and validation assessments

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

• Independently manage validation projects and coordinate cross-functional teams

• Provide technical expertise during regulatory inspections and client audits

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

• Contribute to continuous 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 of 4 years of validation experience in pharmaceutical/biotech manufacturing or comparable regulated industry

• Strong knowledge of cGMP regulations (FDA, EMA, ISO)

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

• Experience writing and executing IQ/OQ/PQ validation protocols

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

• Proven ability to lead validation projects and work cross-functionally

• Strong technical writing and documentation skills

• Experience with risk 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 to capital (CapEx) projects

• Experience with regulatory inspections and client audits

• Knowledge of lean 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