Technical Lead, Cleanroom Certification

Eurofins BioPharma Product Testing North America; Boston (KY); On-site; USD 70,000 - 95,000; Full time

Benefits offered by this job

Life and disability insurance

401(k) with company match

Paid vacation and holidays

Comprehensive medical, dental, and eye

Job summary

Eurofins USA BioPharma Services is hiring a hands-on certifier to lead cleanroom certification and equipment calibration. You will certify cleanrooms, biosafety cabinets, and fume hoods to NSF/ANSI 49, author certification reports, and maintain calibration traceability while investigating out-of-spec results.

The role offers growth toward managerial responsibilities, with a full-time schedule Mon–Fri, and emphasis on precise documentation and customer collaboration.

Qualifications

• Certified cleanroom testing credentials or equivalent hands-on certification.
• Experience with ISO 14644 and NSF/ANSI 49 is preferred.
• Strong documentation and reporting habits are required.

Responsibilities

• Certify and requalify cleanrooms and controlled environments.
• Certify biosafety cabinets and fume hoods to NSF/ANSI 49.
• Author and sign certification reports.
• Own the instrument set and ensure calibration/traceability.
• Investigate failing results and assist customers in root cause analysis.
• Contribute to test methods and procedures for the service line.
• Growth potential to a managerial role.

Skills

Attention to detail

Documentation habits

Judgement

Physical stamina

Education

CETA / CNBT RCP-CT

CETA / CNBT RCP-SCF

NEBB/CNBT or AABC accreditation

High school diploma or equivalent

Technical certification or related degree welcome

Tools

ISO 14644

NSF/ANSI 49

USP knowledge & cGMP

Job description

Company Description

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.

The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. It also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products.

The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. It also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products.

In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.

In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.

Job Description

This is a hands-on role with high growth potential to train and lead technical stuff.

We are looking for a working certifier who wants a bigger job than the one they have now.

• Certify and requalify cleanrooms and controlled environments.
• Certify biosafety cabinets and fume hoods to NSF/ANSI 49.
• Author and sign the certification reports.
• Own the instrument set and keep it calibrated and traceable.
• Investigate results that fail, and help the customer work out why.
• Contribute to the test methods and procedures for the service line.
• The growth potential to a managerial role.

Qualifications

Must have:

• A current certification credential, in good standing. Any one of the following is enough to start:
• CETA / CNBT Registered Certification Professional – Cleanroom Testing (RCP-CT)
• CETA / CNBT Registered Certification Professional – Sterile Compounding Facilities (RCP-SCF)
• NEBB Cleanroom Performance Testing, or AABC

OR

• Two or more years of hands-on cleanroom certification AND willingness and technical readiness to take the exams
• Working knowledge of ISO 14644 and NSF/ANSI 49. Familiarity with USP and , cGMP or state board of pharmacy requirements is a strong plus.
• Careful, accurate documentation habits.
• Sound judgement on your own.
• High school diploma or equivalent. Technical certification or a degree in a related field is welcome but not required.
• Valid driver's licence and a clean driving record. Able to lift and position test equipment, work at height at filter housings, and stay gowned for long periods.

Optional

• NSF/ANSI 49 accredited biosafety cabinet field certifier.

Additional Information

Positions are full time, working Monday-Friday 8am-5pm, overtime as needed. Candidates currently living within commutable distance to Boston, MA are encouraged to apply.

Excellent full time benefits including comprehensive medical coverage, dental, and vision options

• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays

Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.