Lab Systems Engineer - Cell Therapy (Hybrid- Devens, MA)

Lab Systems Engineer – Cell Therapy (Hybrid- Devens, MA) We are seeking a Lab Systems Engineer – Cell Therapy for a global pharmaceutical company. The focus of the role is to 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. This is a 40-hour per-week, 6-month contract (extensions possible), 50% onsite role in Devens, MA. It is possible that there maybesome weeks when they will need to be onsite more often. This is a W2 role as a Stage 4 Solutions employee. Health benefits and 401K are offered.   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 ServiceNow to review and approve digital changes. 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.  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 novel projects. Duties may include internal compliance or efficiency improvement efforts within department. Mentor other IT Digital Plant staff and provide guidance as necessary.  Requirements:   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 applications Experience with PC build and configuration Experience configuring equipment for GMP manufacturing   Comprehensive 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. 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. BS degree in life sciences, engineering or computer field or equivalent experience. Please submit your resume to our network at https://www.stage4solutions.com/careers/ (please apply to the Lab Systems Engineer – Cell Therapy (Hybrid- Devens, MA) role). Please feel free to forward this project opening to others who may be interested. Stage 4 Solutions is an equal-opportunity employer. We celebrate diversity and are committed to providing employees with an inclusive environment that is free of discrimination and harassment. All employment decisions are based on the job requirements and candidates’ qualifications, without regard to race, color, religion/belief, national origin, gender identity, age, disability, marital status, genetic information, or other applicable legally protected characteristics.  Compensation: $40/hr. - $42.37/hr. #LI-SW1

Salary : $40 - $42