Validation Engineer II

Thermo Fisher Scientific•Plainville, MA

1d•$66,000 - $99,000•Onsite

About The Position

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
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.

Responsibilities

Ensuring compliance, quality, and operational excellence across our facilities through comprehensive validation activities.
Working with advanced technologies and diverse teams.
Helping maintain high standards in pharmaceutical manufacturing, laboratory operations, and quality control.

Benefits

Competitive remuneration
Annual incentive plan bonus
Healthcare
A range of employee benefits
Innovative, forward-thinking organization
Outstanding career and development prospects
Exciting company culture that stands for integrity, intensity, involvement, and innovation!
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
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