QC Scientist II / Engineer

Staff Quality Control Environmental Monitoring Engineer

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.

The Drug Product Division (DPD) Greenville, North Carolina site is a multi-purpose pharmaceutical development, manufacturing, and packaging campus. The operation specializes in taking both sterile injectable and oral solid dose drug products from development phase through to commercialization.

The Staff Quality Control Environmental Monitoring Engineer will coordinate the validation environmental monitoring (EM) programs within our pharmaceutical manufacturing facilities. This role involves developing sampling programs in alignment with regulatory standards, coordinating environmental monitoring activities, analyzing data for compliance, and supporting continuous improvement initiatives in previously validated production areas to maintain the highest quality standards.

A Day in the Life:

• Develop and implement EM programs for cleanrooms and controlled environments.
• Coordinate EM validation of air, surface, and personnel samples, including microbiological and particulate sampling.
• Analyze environmental monitoring data to identify trends, ensure compliance with current Good Manufacturing Practices, and implement corrective actions as needed.
• Maintain accurate and detailed records of all monitoring activities, test results, and any deviations or non-conformances.
• Prepare and review comprehensive reports on environmental monitoring results and present findings.
• Investigate and resolve deviations, out-of-specification results, and other quality issues, implementing corrective and preventive actions (CAPAs).
• Collaborate with multi-functional teams, including Quality Assurance (QA), Production, and Engineering.
• Stay engaged with regulatory updates, and advancements in EM technologies and methodologies.

Education:

• Bachelors Degree in Microbiology, Environmental Science, Engineering, or a related field required.
• Equivalent combinations of education, training, and work experience may be considered.

Experience:

• 3+ years proven experience in environmental monitoring within a pharmaceutical or biopharmaceutical manufacturing environment.

Knowledge, Skills, and Abilities:

• Understanding of EM techniques, equipment, and regulatory requirements.
• Familiarity with GMP, FDA, and other regulatory standards for pharmaceutical manufacturing.
• Effective interpersonal skills, both written and verbal.
• Ability to work independently in a fast-paced environment.
• Experience with aseptic processing and cleanroom operations.

Physical Requirements:

Position requires moving about office locations; ability to manipulate (lift, carry, move) objects of light weights up to 25 pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.

What We Offer:

We offer competitive compensation, including annual incentive plan bonus, healthcare, and a range of employee benefits. Employment includes 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!

Compensation:

• Competitive Hourly Pay Rate
• Additional shift differential for 2nd shift and 3rd shift positions
• Annual performance-based bonus
• Annual merit performance-based increase

Excellent Benefits:

• Benefits & Total Rewards | Thermo Fisher Scientific
• Medical, Dental, & Vision benefits-effective Day 1
• Paid Time Off & Designated Paid Holidays
• 401K
• Tuition Reimbursement
• Employee Referral Bonus
• Career Advancement Opportunities

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.