Laboratory Instrument System Administrator

Eurofins BioPharma Product Testing North America; Lancaster (Lancaster County); On-site; USD 85,000 - 105,000; Full time

Benefits offered by this job

Medical coverage

Dental insurance

Vision insurance

Life and disability insurance

401(k) match

Paid vacation and holidays

Job summary

Eurofins USA BioPharma Services in Lancaster, PA seeks a Subject Matter Expert to maintain validated state of instruments and software, perform troubleshooting, and implement CAPA. The role involves qualification testing, software configuration for electronic records, and enforcement of GMP/GLP with a focus on data integrity.

You will review vendor documentation, support validation testing, assist with training, and help integrate new instrumentation into data centre workflows.

Qualifications

• Bachelor's degree in physical science or related field.
• Directly related experience may be substituted for education.

Responsibilities

• Maintain instrument/software in a validated state; perform troubleshooting and CAPA to resolve issues.
• Coordinate validation testing and provide risk-based rationale for testing approach.
• Review vendor and team documentation; keep organized GMP/GLP compliant records.
• Assist with implementing new internal practices and procedures.
• Provide technical input for validation deliverables and procedures.
• Provide training to system users and admins.

Skills

HPLC analysis

Technical writing

Documentation

Team collaboration

Microsoft Word

Excel

Education

Bachelor's in physical science

Tools

Microsoft Word

Excel

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

• Subject Matter Expert (SME) – Maintain instrument/software in a validated state at all times. Perform assessment, trouble‑shooting, repair. Develop and implement CAPA to resolve issues as needed. Ensure completion of preventative maintenance and routine qualification testing. Install, configure software for electronic record compliance. Perform testing to identify gaps and develop remediation as required. Routinely analyze system logs/audit trails, perform software/firmware upgrades, update user account information, and complete periodic system compliance reviews.
• Validation Testing – Determine and/or assist with determining the approach to test and validate instrumentation. Provide technical and risk‑based rationale to support approach. Coordinate installation and/or execute testing (as required).
• Review testing documentation generated by vendors and/or other team members. Compile and maintain documentation in an organised GXP‑compliant manner to demonstrate status.
• Apply GMP/GLP in all areas of responsibility, as appropriate.
• Compliance – Ensure projects are completed in compliance with existing quality systems. Stay current with client, regulatory, validation, IT, and e‑record regulations and requirements. Assist with implementing new internal practices and procedures.
• Research – Research and on‑board new instrumentation; Assist with integration of instrumentation into existing data centre environments and workflows.
• Technical Writing – Provide technical input for validation deliverables, investigations, and develop/enhance procedures in accordance with established quality programmes.
• Training – Provide training to system users and other admins; Assist with developing training programme and procedures.
• Conduct all activities in a safe and efficient manner.
• Perform other duties as assigned.

Qualifications

• Strong computer, scientific, and organisational skills.
• Excellent communication (oral and written) and attention to detail.
• Ability to work independently and as part of a team, self‑motivation, adaptability, and a positive attitude.
• Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions and comply with company policies.
• Experience in the analysis of therapeutic proteins using various HPLC techniques including IEX, SEC, HIC and RP and CE including ICE and CE.
• Excellent oral and written communication skills.
• Effective documentation skills with the ability to author internal technical reports.
• Experience with Microsoft Word and Excel is required.

Minimum Qualifications

• Bachelor's in physical science (chemistry, engineering, computer science, etc.). Additional years of directly related experience may be considered in lieu of degree (two years of directly‑related industry experience is equivalent to one full‑time year of college in a related major).

Additional Information

Position is Full‑time, Monday‑Friday, 8:00 a.m.–5:00 p.m., with overtime as needed. Candidates currently living within a commutable distance of Lancaster, Pennsylvania are encouraged to apply.

Excellent full‑time benefits include:

• 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.