Jobs at FITS LLC

The Associate Tech Engineering role involves troubleshooting mechanical systems, ensuring compliance with industry standards, and improving engineering processes.

Manage an MES project focused on software integration, ensuring compliance, leading technical meetings, and coordinating cross-functional teams.

Manage capital projects in the pharmaceutical sector, overseeing budgets, schedules, design management, and construction implementation while coordinating with stakeholders and resources.

Supports validation activities and develops Master validation plans. Collaborates with the Process Development team and leads quality improvement efforts, focusing on compliance and system adequacy.

Manage strategic supplier partnerships and contract manufacturers to ensure compliant, cost-effective external supply. Lead supplier negotiations, forecasting, issue resolution, process improvements, and cross-functional supply chain planning.

Provide documentation support for Capital Projects in regulated environments: manage engineering documentation approvals, maintain SOPs and project files, support audits and compliance readiness, handle protocols and change controls, and ensure adherence to GMP, GDP, safety, and company policies while collaborating with cross-functional teams.

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.

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.

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 projects to implement automation in a regulated environment, define project scope, manage vendors, and ensure compliance with procedures.

The Quality Engineer will implement quality engineering processes, support validation/certification, generate test protocols, and ensure adherence to quality engineering standards in the manufacturing of medical devices or pharmaceuticals.

Provide engineering support to production lines, troubleshoot equipment issues, monitor metrics, implement improvements, and document investigations.

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.

Lead and execute validation activities for process changes and equipment modifications in pharmaceutical/medical device manufacturing. Manage validation projects, develop process control strategies, prepare validation documentation, coordinate cross-functional teams, provide training, drive process improvements, and ensure compliance with GMP/GDP, safety, and quality requirements while reporting progress to stakeholders.

Lead engineering for Clean Utilities and deviation services in pharmaceutical and medical device manufacturing. Establish and update company-wide engineering policies, develop large project budgets, conduct advanced technical investigations and research, design and direct engineering/process projects, manage engineering staff, and coordinate cross-functional efforts including GMP investigations and deviation documentation.

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.

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