Engineer III, 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, like protecting the environment, making sure our food is safe or helping find cures for cancer.

DESCRIPTION:
Join our validation engineering team, where you'll ensure product quality and regulatory compliance across pharmaceutical manufacturing operations. As a Validation Engineer III, you'll lead complex validation projects for equipment, processes, utilities, and computer systems while collaborating with cross-functional teams to maintain GMP standards. You'll contribute to continuous improvement initiatives, support team members, and provide technical expertise during client and regulatory audits. This role offers professional growth opportunities as you help enable life-changing therapies through robust validation strategies and execution.

REQUIREMENTS:

• Bachelor's Degree in Engineering, Life Sciences, Chemistry or related technical field. Advanced degree preferred

• 5 years of experience in validation in pharmaceutical/biotech manufacturing or comparable regulated industry. 3 years of experience in validation in pharmaceutical/biotech manufacturing or comparable regulated industry with an advanced degree

• Experience writing and executing validation protocols, including IQ/OQ/PQ documentation

• Expertise in risk assessment methodologies and statistical analysis

• Experience leading complex validation projects and coordinating cross-functional teams

• Advanced problem-solving abilities and root cause analysis experience

• Experience with regulatory inspections and client audits preferred

Knowledge, Skills, Abilities:

• Strong knowledge of cGMP regulations, including FDA, EMA and ISO requirements

• Proficiency with validation of manufacturing equipment, utilities, cleaning processes and computer systems

• Strong technical writing and documentation skills

• Excellent verbal/written communication and interpersonal skills

• Proficiency with relevant software tools (MS Office, statistical packages, validation systems)

• Knowledge of lean manufacturing and continuous improvement methodologies

• Ability to work in cleanroom environments when required

• Flexibility to work extended hours or alternate shifts based on project needs