Jobs at FITS LLC

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.

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).

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 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 support automation projects for pharmaceutical capital projects: coordinate vendors/integrators, troubleshoot PLC/HMI/SCADA/DCS installations, monitor schedules, prepare status reports, update technical documentation, support commissioning/qualification (FAT/SAT, CSV, PQ), and collaborate with Quality, EHS, IT, and Manufacturing.

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.

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.

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.

Provide EHS program governance for manufacturing projects: support project leaders, monitor activities, develop and present safety metrics and training, forecast and mitigate safety risks, ensure regulatory compliance, enforce contractor safety, monitor indicators, support incident investigations, and drive corrective actions and safety initiatives.

Lead automation projects for pharmaceutical manufacturing: manage vendors/integrators, troubleshoot PLC/HMI/SCADA/DCS systems, oversee commissioning/qualification (FAT/SAT, CSV, PQ), coordinate cross-functional teams, monitor schedules/budgets, support audits and CAPAs.

Lead and execute capital projects in a regulated manufacturing environment. Interpret design documents, coordinate contractors and vendors, manage project documentation (change controls, business cases, schedules), prepare progress reports, resolve drawing/disciplines conflicts, and support system turnover and inspections while ensuring quality, communication, and compliance across stakeholders.

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 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.

Lead engineering for pharmaceutical capital projects: develop scopes, design criteria and specs; review drawings and 3D models; manage procurement, contractors, schedules, commissioning, validation and compliance with GMP/FDA/OSHA; perform field inspections, change control, risk mitigation, and ensure projects meet cost, quality and timeline objectives.

Maintain, edit, archive, and coordinate engineering drawings and related documentation. Lead drawing revision and approval workflows, manage project reporting and communication, ensure adherence to client systems and procedures, keep training current, and provide additional drafting and coordination support for regulated pharmaceutical/biotech capital projects.

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.

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.

Manage daily supply chain operations for pharmaceutical/medical device materials ensuring cGMP compliance. Oversee receipt, storage, transport, master production scheduling, demand/supply coordination, business continuity, and regulatory interactions. Implement process improvements, SOP/CAPA documentation, and partner with internal teams and suppliers to meet performance targets.