Validation Engineer II

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards

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 collaborative team as a Validation Engineer II at Thermo Fisher Scientific, where you'll contribute to global healthcare and scientific advancement. In this role, you'll be responsible for ensuring compliance, quality, and operational excellence across our facilities through comprehensive validation activities. Working with advanced technologies and diverse teams, you'll help maintain high standards in pharmaceutical manufacturing, laboratory operations, and quality control.

REQUIREMENTS:
• Advanced degree with no prior experience required, Bachelor's degree plus 2 years of validation experience in GMP/regulated environment, or High School Diploma with 4+ years of experience.
• Preferred Fields of Study: Engineering, Life Sciences, Chemistry, or related technical field
• Valid driver's license with ability to travel up to 25% as needed
• Comprehensive knowledge of cGMP, FDA regulations, and industry standards (ISO, GAMP5)
• Strong technical writing skills for validation documentation
• Experience with IQ/OQ/PQ protocols and execution
• Proficiency in risk assessment and gap analysis
• Experience managing validation projects independently
• Strong data analysis and problem-solving capabilities
• Clear verbal and written communication skills
• Proficient in Microsoft Office applications
• Knowledge of calibration and metrology principles
• Experience with automation systems and computer system validation
• Ability to work in cleanroom environments when required
• Effective interpersonal skills for team collaboration
• Ability to manage multiple projects
• Experience with quality management systems and documentation
• Knowledge of statistical analysis and process control methods
• Consistent record of completing projects on schedule in a deadline-oriented environment

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

Other

Relocation assistance is not provided.

Must be legally authorized to work in the United States now and in the future, without sponsorship.

Must be able to pass a comprehensive background check, which includes a drug screening.

Compensation and Benefits

The salary range estimated for this position based in Massachusetts is $66,000.00–$99,000.00.

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs

• Employee assistance and family support programs, including commuter benefits and tuition reimbursement

• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy

• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan

• Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards