Validation Engineer III

Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Warehouse

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:
Advanced Degree plus 3 years of experience, or Bachelor's Degree plus 5 years of experience in validation in pharmaceutical/biotech manufacturing or comparable regulated industry
Preferred Fields of Study: Engineering, Life Sciences, Chemistry or related technical field
Strong knowledge of cGMP regulations, including FDA, EMA and ISO requirements
Experience writing and executing validation protocols, including IQ/OQ/PQ documentation
Expertise in risk assessment methodologies and statistical analysis
Proficiency with validation of manufacturing equipment, utilities, cleaning processes and computer systems. Experience with bioreactors, chromatography, autoclaves, fill lines preferred.
Experience leading complex validation projects and coordinating cross-functional teams
Strong technical writing and documentation skills
Advanced problem-solving abilities and root cause analysis experience
Excellent verbal/written communication and interpersonal skills
Proficiency with relevant software tools (MS Office, statistical packages, validation systems)
Experience with regulatory inspections and client audits preferred
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
May require up to 25% travel

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 $83,300.00-$125,000.00.

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: