Technical Lead, Cleanroom Certification

Eurofins USA BioPharma Services; Raleigh (NC); On-site; USD 70,000 - 100,000; Full time

Benefits offered by this job

Life and disability insurance

401(k) with company match

Paid vacation and holidays

Job summary

Eurofins USA BioPharma Services is seeking a hands-on certifier to lead cleanroom certification and qualification efforts. The role involves certifying biosafety cabinets and fume hoods to NSF/ANSI 49, authoring certification reports, and owning the instrument set while maintaining calibration and traceability.

The position offers growth toward a managerial role and requires current credentialing in good standing, plus several years of related experience. Raleigh-area commute is expected.

Qualifications

• Must have a current certification credential in good standing.
• Two or more years of hands-on cleanroom certification experience is a strong plus.
• Familiarity with ISO 14644 and NSF/ANSI 49; USP <797> and <800> knowledge is a plus.

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 keep it calibrated and traceable.
• Investigate results that fail and help customers determine root cause.
• Contribute to test methods and procedures for the service line.
• Grow into a managerial role.

Education

High school diploma or equivalent

Job 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.

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.

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 <797> and <800>, cGMP or state board of pharmacy requirements is a strong plus.

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, workingMonday-Friday 8am-5pm,overtime as needed. Candidates currentlyliving within commutable distance to Raleigh, NCare 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.