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:
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
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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