* 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 organized GXP compliant manner to demonstrate status.
* Applies 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 center environments and workflows
* Technical Writing - Provide technical input for validation deliverables, investigations, and develop/enhance procedures in accordance with established quality programs
* Training - Provide training to system users and other admins; Assist with developing training program and procedures
* Conducts all activities in a safe and efficient manner
* Performs other duties as assigned
Strong computer, scientific, and organizational 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
* The candidate must have effective documentation skills with the ability to author internal technical reports
* Experience with Microsoft Word and Excel is required, 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 related major)
Company DescriptionEurofins 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 Organization 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 Organizations. It also has a rapidly developing
Additional InformationPosition is full-time, Monday - Friday, 8am - 5pm. Candidates currently living within a commutable distance of Lancaster, PA 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.
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