Jobs at FITS LLC

Support health, safety, and project coordination for engineering and construction projects: generate and monitor daily work permits, review safety plans, manage contractor safety and onboarding, maintain safety documentation and reports, participate in safety meetings, and promote safe work practices in the field.

Designs, executes, and interprets experiments for process development; generates robust data; supports formulation and aseptic filling operations; performs process monitoring, data trending, and statistical analysis; leads deviations/investigations and root-cause/product-impact assessments; authors scientific and regulatory reports; collaborates on project teams and may mentor others.

Manage supplier quality for medical device components: qualify and audit suppliers, monitor parts through manufacturing, resolve supplier issues, support Pre‑Market Supplier Quality and NPD collaboration, define receiving inspection and test method validation, and drive continuous improvement.

Lead engineering validation and equipment design projects for pharmaceutical clients. Develop procedures, supervise a small engineering team, coordinate cross-functional stakeholders, manage budgets and consultants, and deliver complex validation and design solutions on schedule and within quality constraints.

Lead engineering work for assembly and packaging manufacturing: develop and improve processes, supervise small engineering teams, manage projects, coordinate cross-functional stakeholders, and deliver validated, reliable equipment and documentation.

Support planning and execution of pharmaceutical capital projects from initiation through closeout. Coordinate engineering, manufacturing, maintenance, validation, quality, and automation teams. Manage schedules, budgets, risks, procurement, contractor coordination, equipment installation, commissioning/qualification, and ensure GMP and engineering standards compliance.

Provide technical and sustaining engineering support for medical device manufacturing. Recommend and implement process/equipment modifications, ensure regulatory compliance, develop statistical/process control methods, conduct feasibility and validation work, and collaborate with product design to optimize production yields.

Reviews and approves pharmaceutical manufacturing quality documentation, validation protocols, investigations, CAPAs, change controls, risk assessments, alarms, work orders, and environmental reports. Leads investigations and site audits, supports incident triage, automation, facilities, and environmental programs, represents QA on new product introduction teams, manages quality procedures, and authorizes lot disposition and shipment. The role requires pharmaceutical or regulated-industry experience, bilingual English and Spanish communication, project management skills, and flexibility across morning and afternoon shifts.

Support and maintain quality standards and protocols for medical device manufacturing. Collaborate with engineering and production to design inspection and test methods, perform QA testing and statistical analysis, investigate nonconforming materials, and implement corrective actions. May focus on incoming materials, production control, product evaluation, or reliability.

Lead capital projects for pharmaceutical/medical device manufacturing facilities from design through operational verification. Act as owners representative, manage budgets, schedules, contractors, safety, quality, and regulatory compliance. Conduct site walkdowns, oversee construction of process trains and clean utilities, review change orders, and maintain stakeholder communication.

Lead planning, execution, and closeout of enterprise security camera and low-voltage IT projects. Manage schedules, budgets, vendors, contractors, cross-functional teams, risks, testing, change control, quality, and compliance while reporting progress to leadership.

Lead and author investigations for manufacturing quality issues in a regulated biotech/pharma environment. Manage deviations, complaints, NC/CAPA, process monitoring, trend analysis, root cause evaluations, and procedure ownership. Provide troubleshooting, training support, and ensure timely closure of corrective actions.

Lead technical strategy and delivery for robotics and ASRS across sites: define architectures, establish standards, integrate PLC/HMI/safety/robotics with WMS/WES/WCS/EMS, oversee OT/IT decisions, manage FAT/SAT/commissioning, drive root-cause resolution, ensure functional safety, and supervise OEMs/integrators through handover and sustainment.

Manage supplier quality for medical device components: qualify and audit suppliers, monitor parts through manufacturing, support pre‑market supplier quality for NPD, define inspection and test method validation, and collaborate on control plans and sampling strategies to ensure GMP and regulatory compliance.

Support fermentation manufacturing and validation activities in a pharmaceutical/medical device environment. Provide technical troubleshooting, equipment installation/operation support, process optimization, documentation, CAPA and change control, and training. Participate in process validation, preventive maintenance planning, safety procedures (e.g., LOTO), and daily operations including 24/7 technical support and team meetings.

Support quality engineering for new products and processes: validate and certify processes, equipment, software and facilities; generate test protocols and qualification reports; review quality documents and change controls; develop SOPs and technical transfers; use risk management tools to prevent failures and ensure GMP/GDP compliance while supporting cross-functional projects.

Manage pharmaceutical manufacturing quality systems, including change control, procedure updates, process validation, batch records, nonconformance triage, CAPA execution, investigations, trend monitoring, and quarterly process reports. Provide troubleshooting support, assess process performance, establish monitoring parameters and control limits, support training, and ensure timely closure of quality actions. The role requires collaboration with manufacturing operations and scientific expertise in a regulated environment.

The C&Q Lead will manage overall commissioning and qualification planning, coordinate multidisciplinary meetings, ensure compliance, handle change control, and oversee documentation related to CQV activities in the pharmaceutical industry.

This role involves supporting quality assurance in manufacturing, including compliance, systems validation, and IT systems integration, requiring communication and teamwork.

Coordinates procurement for an asset management project by creating and tracking purchase orders, processing requisitions, sourcing and negotiating with suppliers, monitoring budgets, expediting deliveries, supporting contracts, maintaining records, ensuring policy compliance, and preparing procurement reports. The role collaborates with project, finance, operations, and technical teams and requires procurement experience in the pharmaceutical or medical device industry.