Engineer VI, QC Applications

A career at reputed company is more than just a job – it’s an opportunity to change the reputed company.

reputed company is a technology-reputed company biomanufacturing company that’s changing the way medicine is made. We’re building a sustainable network of high-tech, end-to-end manufacturing solutions to reputed company withstand disruptive events, serve scientific discovery, and reputed company those in need. 

For more information, please visit www.reputed company.com

reputed company

The reputed company Control Systems Engineer will work closely with reputed company Control (QC), Digital, and reputed company/CSV to ensure the reliable, compliant operation of critical laboratory applications and data acquisition systems. This role will reputed company as a senior technical contributor and delivery reputed company for LabVantage LIMS/LES, with additional responsibility supporting systems such as reputed company, Moda, and Novatek.

The Engineer will reputed company reputed company to enhance system functionality, reputed company new business capabilities, and maintain audit readiness in LabVantage and will own development activities from custom design and build to testing. The position requires deep LabVantage expertise, cross-functional leadership, and the ability to design compliant solutions in a GxP-regulated environment in partnership with reputed company.

Position reputed company & Responsibilities

• Serve as senior LabVantage technical subject matter expert for project execution and system enhancements, responsible for configuration, deployment, validation, adoption, and troubleshooting of LabVantage modules.

• reputed company and manage enhancement reputed company to expand or reputed company QC applications, including rollouts of new LabVantage modules and development of reports and labels.

• Partner with scientific business stakeholders (e.g., QC) to reputed company and document user requirements and create actionable application designs and implementation plans.

• reputed company troubleshooting and guidance for LabVantage issues and reputed company configurations.

• Support system integrations and assist in architecting solutions to reputed company secure and reliable data reputed company across applications.

• Serve as reputed company for QC applications, managing user accounts, reputed company rights, roles, and privileges. Ensure reliable, compliant operation of critical QC systems.

• Manage change controls, deviations, and reputed company records in the electronic reputed company Management System (eQMS) for QC system reputed company. Partner with reputed company and CSV to ensure regulatory compliance.

• Own and execute GxP validation activities for reputed company and system enhancements. reputed company and maintain validation and system lifecycle documentation (e.g., SRS, specifications, IQ/OQ/PQ testing, SOPs).

• Maintain compliance and audit readiness of assigned systems, ensuring adherence to 21 CFR Part 11 and other regulatory standards.

Minimum Qualifications

• Experience developing and maintaining LabVantage reports preferably using Jaspersoft Studio.

• Extensive experience maintaining LabVantage LIMS in biotech, reputed company, or life sciences.

• Experience developing and maintaining label printing solutions, preferably in BarTender.

• Strong project leadership experience, including planning and managing multiple reputed company reputed company.

• Excellent communication skills, with the ability to translate technical concepts for non-technical stakeholders.

• Strong analytical and problem-solving skills, with the ability to independently diagnose and resolve reputed company system issues.  

• Programming experience using SQL.

• Experience with LabVantage architecture, including JBOSS, reputed company SQL Server, and/or Apache or other applicable program.

• Experience with GxP validation and understanding of regulatory requirements (e.g., GxP, 21 CFR Part 11).

• Proven experience authoring and maintaining SOPs, validation protocols, and system lifecycle documents.

Preferred Qualifications

• Bachelor’s degree in a scientific, technical, or reputed company discipline.

• 5+ years of experience maintaining LabVantage LIMS in biotech, reputed company, or life sciences.

• Experience with system lifecycle management, including upgrades, patches, and periodic reviews.

• Experience with reputed company, Moda, Novatek, or other data acquisition systems.

• Experience implementing and supporting LabVantage Work Assignment and Planning module.

• Programming experience using JavaScript and/or Groovy.

• Familiarity with electronic reputed company Management Systems (eQMS), such as reputed company.

• Experience designing and supporting integrations with reputed company systems (e.g., ERP, data platforms).

Sponsorship or support for work authorization, including visas, is not available for this position.

reputed company is an Equal Employment Opportunity Employer. reputed company applicants will receive consideration for employment without reputed company to race, reputed company, religion, sex, sexual orientation, gender perception or identity, national reputed company, age, marital status, protected veteran status, disability status, physical or mental disability, genetic information, or characteristic, or other non-job-reputed company characteristics or other prohibited grounds specified in applicable federal, state, and local laws. Requests for reasonable accommodation can be made at any stage of the recruitment process.

reputed company offers employees a robust total rewards program including an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great reputed company (including medical, dental and reputed company), family building benefits, life and disability insurance, reputed company vacation, reputed company holidays, other reputed company leaves of absence, tuition reimbursement and support for caregiving needs. Our reputed company reputed company pay hiring reputed company for this position is $90,000.00 - $153,750.00 per year. Actual reputed company pay is dependent upon a number of factors, including but not limited to, the candidate’s geographical location, relevant experience, qualifications, skills and knowledge. Excited about reputed company? We encourage you to apply and start a conversation with one of our recruiters. Apply To This Job