Validation engineer - united states, mahmud-e eraqi
Our client, an engineering, automation, and integration company, is currently seeking 3 junior-level validation engineers for contract to hire in lexington, massachusetts for their biopharma group. these positions will begin in june/july 2022.
essential duties and job functions
validation engineer
reviews validation packets for completeness and accuracy, sound rationale, compliance with validation policies and procedures, and accurate data analysis. compares results against acceptance criteria and bring exceptions and deviations to management's attentionmaintains appropriate validation documentation and files in accordance with regulatory requirements and internal procedureseffectively apply validation methodology and standardssupport, investigate and troubleshoot problems and determine solutionsprovide technical assistance during investigations of process /equipment / cleaning / validation issues. generate and resolve validation deviations / protocol discrepanciesÂ
knowledge, experience, and skills
demonstrates understanding and application of validation principles, concepts, and practices, and standards.demonstrates proficiency in current good manufacturing practices (gmps) and safety regulations.demonstrates knowledge of pharmaceutical and biotech processes, and root cause failure analysis.demonstrates knowledge in steam sterilization principles and autoclave cycle development.demonstrates excellent verbal, written, and interpersonal communication skills.proficient in microsoft office applications3+ years of relevant experience and a bs or ba or related fields.2+ years of relevant experience and a ma or mba.has previous experience in biotech or pharmaceuticals industry.has previous experience in validation in highly regulated manufacturing environments.established experience with kaye validator, ellab, or other thermal mapping instruments required.
with over 90 years' combined experience, nes fircroft (nes) is proud to be the world's leading engineering staffing provider spanning the oil & gas, power & renewables, infrastructure, life sciences, mining, automotive and chemicals sectors worldwide.with more than 100 offices in 45 countries, we are able to provide our clients with the engineering and technical expertise they need, wherever and whenever it is needed. we offer contractors far more than a traditional recruitment service, supporting with everything from securing visas and work permits, to providing market-leading benefits packages and accommodation, ensuring they are safely and compliantly able to support our clients.
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