Quality Engineer - Clinical Labeling

Location: Bohemia, New York, United States of America

Category: Quality & Regulatory

Employment Type: Full time

Work Schedule

Environmental Conditions

Job Description

Quality Engineer - Clinical Labeling

Division / Site Specific Information

The Bohemia, NY site is a key Thermo Fisher Scientific Global Label Services location, specializing in clinical trial labeling design, production, translation, and regulatory support for pharmaceutical and biotechnology companies.

As a core Global Label Services site, Bohemia delivers fast, high-quality clinical trial labeling through integrated design, printing, inspection, translation, and regulatory support. The site enables accelerated global studies with advanced OCR inspection, temperature-specific labeling expertise, and dedicated clinical labeling project management.

Discover Impactful Work

As part of Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. In this role, you will help ensure quality excellence and regulatory compliance across clinical manufacturing operations—supporting our Mission to enable customers to make the world healthier, cleaner, and safer.

You’ll collaborate across functions to uphold the highest quality standards while helping deliver clinical trial materials that support life-changing therapies worldwide.

Day in the Life

• Ensure compliance with cGMP, ISO 9001, and applicable global regulatory requirements (FDA, EMA, etc.)

• Maintain and improve Quality Management Systems (QMS) to ensure consistent quality performance

• Lead and support deviation investigations, root cause analysis, and CAPA implementation

• Manage and participate in change control activities and risk assessments (FMEA)

• Support internal and external audits, including regulatory inspections and customer audits

• Partner cross-functionally to resolve quality issues and drive continuous improvement initiatives

• Support validation and qualification activities in alignment with ISPE principles

• Utilize quality tools, metrics, and statistical analysis to monitor and improve processes

• Communicate effectively with internal teams, external customers, and regulatory bodies

Keys to Success

Education

• Advanced degree with 3+ years of relevant experience, or

• Bachelor’s degree with 5+ years of relevant experience

• Engineering, Life Sciences, Chemistry, or a related technical discipline (required)

Experience

• Experience in quality assurance within a regulated industry (pharmaceutical, medical device, or biotech)

• Hands-on experience with:

  • CAPA and deviation management

  • Change control processes

  • Risk management and FMEA

  • Document control systems

  • Internal and external auditing

• Experience supporting validation and qualification protocols

• ASQ certifications (CQE, CQA) strongly preferred

Knowledge, Skills, Abilities

Knowledge

• Strong understanding of cGMP, ISO standards, and global regulatory expectations

• Familiarity with ISPE validation and qualification concepts

• Knowledge of statistical analysis and quality tools

Skills

• Advanced problem-solving and root cause analysis

• Strong project management and organizational skills

• Proficiency with quality management systems and MS Office

• Excellent verbal and written communication skills

Abilities

• Ability to work independently while collaborating across functions

• High attention to detail with the ability to maintain a broader quality perspective

• Strong interpersonal skills to effectively partner with internal and external stakeholders

Benefits

We offer competitive remuneration, an annual incentive plan bonus, healthcare, and a comprehensive total rewards package. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization and outstanding career and development prospects.

Benefits include:

• Medical, Dental, & Vision benefits – effective Day 1

• Paid Time Off & Designated Paid Holidays

• Retirement Savings Plan

• Tuition Reimbursement

Relocation assistance is not provided

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

Must be able to pass a comprehensive background check, including drug screening

Compensation and Benefits

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