Senior Engineer - Lab Systems, Cell Therapy_26-00995

Job Title: Senior Engineer – Lab Systems, Cell TherapyJob ID:26-00995Locations: 100% onsite at Devens, MADuration: 6 MonthsWork Schedule: Mon-Fri 8 am-5 pmTop Skills:Experience in the pharmaceutical industry working in a regulated GMP environmentExperience with the administration of IT/computer systemsExperience with PC build and configurationExperience in configuring equipment for GMP manufacturingSummary:Provide support and enhancements for the administration of benchtop instrumentation applications, PC hardware, and IT administrative tools within a GxP environment. Support would encompass various instrument types such as cellometers, plate readers, and flow cytometers throughout the site which include laboratory and manufacturing areas.Responsibilities:Coordinate Lead and support administration of quality and laboratory applications including their software development life cycle activities and technical support.Review and approve validation lifecycle documents as part of CSV activities, supporting the risk assessments, specifications, pre- and post-approval of qualification testing.Participates in regulatory audits as Digital Plant secondary representative and assists in generating responses to audit observations.Provides IT quality support to Devens CTF Digital Plant team through quality review and approval of investigations or change controls, deviation ownership of computerized system events, and CSV activities.Interact with Infinity (Quality Management System) to enter deviations and associated actions, investigations and associated root cause analysis, supporting data, corrective action/preventative action (CAPA) and effectiveness reviews as needed.Interact with ServiceNow to review and approve digital changes.Provide quality support of Digital Plant programs and system maintenance activities.Responsible for routine completion of quality events, quality actions, risk assessments, and other compliance documentation.Ability to support on-call deviations on a rotational basis.Ensure that Digital Plant standard operating procedures (SOPs) and procedural methodologies employed to maintain the validated state are regularly reviewed and updated, as needed.Assist in development of appropriate validation methodologies in collaboration with Operations Management and Quality Assurance for Client projects.Duties may include internal compliance or efficiency improvement efforts within department.Mentor other IT Digital Plant staff and provide guidance as necessary.Qualifications:BS degree in life sciences, engineering or computer field or equivalent experience.Minimum of 2 years of experience working in regulated industries such as Biotech, Pharmaceutical, and Medical Devices familiarity supporting benchtop instruments and applications within a GxP compliant manufacturing or laboratory setting.Demonstrated track record of IT Support in a fast-paced regulated environment supporting benchtop instruments, quality and lab applicationsComprehensive knowledge of Data Integrity guidance, GxP compliance, Software Development Life Cycle, and Good Documentation Practices.Comprehensive knowledge of SOPs, cGMPs and other compliance requirements and regulatory guidelines (FDA, EU) and the know how to work and manage within a regulatory environment.Demonstrated leadership skills and the ability to negotiate in a complex environment.Excellent verbal and written communication skills.The ability to plan and lead small and medium-sized projects and enhancements.Self-driven and capable of prioritizing.Understanding of network, databases, servers, and PCs.Understanding of administration and usage of Waters NuGenesis, FCS Express, Veeva Document Management System, Infinity, ServiceNow, and emerging technology is preferred.Ability to apply lean and OpEx principles.Represent the department before our stakeholders, regulatory agencies, and managementContact:Sunny Rajput | sunny.r@sunrisesys.com | URL: www.sunrisesys.comCompany DescriptionFounded in 1990, Sunrise Systems is an award winning IT/Professional Staffing firm to Fortune 500 and State/Local Government Agencies.

Salary : $42 - $43