Technical Lead, Cleanroom Certification

Eurofins USA BioPharma Services; Portsmouth (NH); On-site; USD 65,000 - 95,000; Full time

Benefits offered by this job

NSF/ANSI 49 field certifier (optional)

Job summary

Eurofins USA BioPharma Services in Portsmouth, NH seeks a hands-on certifier to train and lead technical staff with growth toward a managerial role. You will certify and requalify cleanrooms, certify biosafety cabinets to NSF/ANSI 49, and author certification reports.

A current certification credential is required (RCP-CT, RCP-SCF, NEBB or AABC) or 2+ years of hands-on cleanroom experience. A high school diploma is required; driving license and ability to lift/test equipment are needed.

Qualifications

• Must hold a current certification credential (e.g., RCP-CT, RCP-SCF, NEBB or AABC)
• ISO 14644 and NSF/ANSI 49 familiarity; USP <797> & <800>, cGMP knowledge a strong plus
• Two+ years hands-on cleanroom certification experience acceptable
• High school diploma or equivalent; technical certification or degree welcome but not required
• Valid driver’s license; ability to lift and position test equipment, work at height

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 causes
• Contribute to test methods and procedures for the service line
• Growth potential to a managerial role

Skills

Cleanroom certification

ISO 14644 knowledge

Regulatory awareness

Driver's license

Education

High school diploma or equivalent

Technical certification or degree welcome

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 Portsmouth, NHare 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.