Jobs at FITS LLC

The Product Engineer supports production engineering in testing methods, device issues, equipment design, and ensures compliance with quality standards in manufacturing operations.

Manage DeltaV automation upgrade projects in regulated environments, coordinating engineering, IT, and vendors while ensuring compliance and risk mitigation.

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.

Serve as site EH&S liaison for capital projects, ensuring regulatory compliance and process safety integration. Lead PSSRs, MOC, commissioning, inspections, and field oversight. Review designs and equipment for OSHA/EPA/NFPA/ASME/ANSI compliance, collaborate with cross-functional teams, track corrective actions, provide technical guidance on machine safeguarding, hazardous energy, pressure systems and gases, and use EH&S systems to document reviews and controls. Support off-hours shutdowns/startups and travel as needed.

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.

Lead and coordinate design verification for pharmaceutical/medical device projects: develop design requirements, maintain schedules, liaise with A/E firms and construction, oversee verification providers, manage discrepancies, collect metrics, and complete verification closeout.

Manage deviation investigations within GMP/GxP environments, owning major and minor deviations through the full investigation lifecycle. Coordinate cross-functional teams, conduct impact analyses for products/systems/changes, evaluate system and business process feasibility, ensure computerized manufacturing systems meet requirements, and prepare complex project documentation.

Manage NC/CAPA and audit observation processes, perform investigations in ETQ, plan and execute product dispositions, analyze quality trends, lead cross-functional corrective action implementation, and ensure compliance with medical device regulations (FDA 21 CFR, GMP/GDP).

Serve as the primary EH&S liaison for capital projects: review designs, ensure regulatory compliance (OSHA, EPA, NFPA, ASME), coordinate PSSR/MOC/commissioning, conduct field inspections, support shutdowns/startups, provide technical guidance on machine safeguarding, hazardous energy control, pressure systems and gases, and track corrective actions using EH&S digital systems.

Support and implement capital projects for GMP facilities: develop scope and design, obtain permits, manage bidding and budgets, schedule and oversee construction, coordinate with production for shutdowns and tie-ins, control changes, and support commissioning and validation while producing status reports, cost estimates, and resource plans.

Manage and integrate operational readiness schedules for GMP manufacturing startups. Facilitate cross-functional workshops, track readiness activities (PV/CV, training, SOPs, C&Q, automation, materials, EHS), report progress and risks, and maintain GMP-compliant project documentation to support successful facility commissioning and startup.

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.

Manage all phases of equipment transfer and manufacturing projects in a regulated environment: planning, scheduling, budgeting, risk mitigation, C&Q support, cross-functional coordination, and regulatory compliance. Track project costs, resources, and timelines while implementing tools and process improvements to meet quality and client objectives.

The job involves overseeing capital projects, ensuring compliance with regulations, developing project documentation, scheduling, and managing resources while promoting a productive work environment.

Coordinate capital projects in a regulated (pharmaceutical/medical device) environment: support planning and scheduling, contractor coordination, risk assessments, document tracking, status reporting, and GMP/GDP compliance, working with project managers and cross-functional teams to deliver projects on time and on budget.

Support quality and validation activities for medical device manufacturing: perform compliant validation of quality IT systems, coordinate with stakeholders, maintain validation documentation, administer/configure systems, support product transfers with focus on sterilization and final packing, and execute process validation, statistical analysis, PFMEA, and first-time quality efforts.

The Sr. Project Manager will oversee project development and implementation in Capital Projects, managing budgets and cross-functional teams for successful outcomes.

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 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.

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.